{
"NDC": [
{
"NDCCode": "58118-0812-8",
"PackageDescription": "30 CAPSULE in 1 BLISTER PACK (58118-0812-8)",
"NDC11Code": "58118-0812-08",
"ProductNDC": "58118-0812",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170727",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090705",
"LabelerName": "Clinical Solutions Wholesale, LLC",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2018-11-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "11822-0812-8",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (11822-0812-8) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "11822-0812-08",
"ProductNDC": "11822-0812",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pain Relief",
"ProprietaryNameSuffix": "Extra Strength",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19930402",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Rite Aid Corporation",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2024-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "19930402",
"EndMarketingDatePackage": "20240923",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to:headachemuscular achesbackachethe common coldtoothacheminor pain of arthritispremenstrual and menstrual cramps. temporarily reduces fever."
},
{
"NDCCode": "60905-0812-0",
"PackageDescription": "8.8 mL in 1 BOTTLE (60905-0812-0) ",
"NDC11Code": "60905-0812-00",
"ProductNDC": "60905-0812",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Teint Couture Everwear 24h Wear Satin Finish Full Coverage And Comfort Broad Spectrum Spf 20 P200",
"NonProprietaryName": "Octinoxate, Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190401",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "LVMH Fragrance Brands",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
"StrengthNumber": "30; 17.5",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-10-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190401",
"SamplePackage": "Y",
"IndicationAndUsage": "helps prevent sunburn if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions."
},
{
"NDCCode": "80491-0812-8",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (80491-0812-8) / 10 TABLET, FILM COATED in 1 BLISTER PACK (80491-0812-7) ",
"NDC11Code": "80491-0812-08",
"ProductNDC": "80491-0812",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tryvio",
"NonProprietaryName": "Aprocitentan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240320",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA217686",
"LabelerName": "Idorsia Pharmaceuticals Ltd",
"SubstanceName": "APROCITENTAN",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2024-06-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240320",
"SamplePackage": "N",
"IndicationAndUsage": "TRYVIO, in combination with other antihypertensive drugs, is indicated for the treatment of hypertension, to lower blood pressure (BP) in adult patients who are not adequately controlled on other drugs. Lowering BP reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes. There are no controlled trials demonstrating reduction of risk of these events with TRYVIO. Control of high BP should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve BP goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is BP reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher BPs, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from BP 2 reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower BP goal.",
"Description": "TRYVIO (aprocitentan) is an ERA. The chemical name of aprocitentan is N-[5-(4-bromophenyl)-6- [2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-sulfamide. It has a molecular formula of C16H14Br2N6O4S and a molecular weight of 546.2 g/mol. The structural formula is. Aprocitentan is a white to off-white powder that is insoluble in water. TRYVIO is available as film-coated 12.5 mg strength tablets for oral administration. The inactive ingredients in TRYVIO are croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The film coating contains the following inactive ingredients: hydroxypropyl cellulose, iron oxide black, iron oxide red, iron oxide yellow, polyvinyl alcohol, silica colloidal hydrated, talc, titanium dioxide, and triethyl citrate."
},
{
"NDCCode": "16110-812-30",
"PackageDescription": "1 TUBE in 1 CARTON (16110-812-30) > 30 g in 1 TUBE",
"NDC11Code": "16110-0812-30",
"ProductNDC": "16110-812",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluoroplex",
"NonProprietaryName": "Fluorouracil",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19931203",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA016988",
"LabelerName": "Almirall, LLC",
"SubstanceName": "FLUOROURACIL",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "19931203",
"SamplePackage": "N",
"IndicationAndUsage": "FLUOROPLEX Cream is indicated for the topical treatment of multiple actinic (solar) keratoses.",
"Description": "FLUOROPLEX® (fluorouracil) 1% Topical Cream is an antineoplastic/antimetabolite product for dermatological use. Fluorouracil has the empirical formula C4H3FN2O2 and a molecular weight of 130.08. It is sparingly soluble in water and slightly soluble in alcohol. The pH is approximately 8.5. Structural Formula. Fluorouracil. Chemical Name:2,4(1H,3H)-Pyrimidinedione, 5-fluoro-. FLUOROPLEX 1% Topical Cream contains. Active Ingredient: fluorouracil 1.0%. Inactive Ingredients: benzyl alcohol, emulsifying wax, isopropyl myristate, mineral oil, purified water, and sodium hydroxide."
},
{
"NDCCode": "24208-812-05",
"PackageDescription": "1 BOTTLE, DISPENSING in 1 CARTON (24208-812-05) > 5 mL in 1 BOTTLE, DISPENSING",
"NDC11Code": "24208-0812-05",
"ProductNDC": "24208-812",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Timoptic",
"NonProprietaryName": "Timolol Maleate",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20161230",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018086",
"LabelerName": "Bausch & Lomb Incorporated",
"SubstanceName": "TIMOLOL MALEATE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2022-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20161230",
"SamplePackage": "N",
"IndicationAndUsage": "TIMOPTIC Ophthalmic Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.",
"Description": "TIMOPTIC® (timolol maleate ophthalmic solution) is a non-selective beta-adrenergic receptor blocking agent. Its chemical name is (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. The optical rotation of timolol maleate is. Its molecular formula is C13H24N4O3SC4H4O4 and its structural formula is. Timolol maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water; sparingly soluble in ethanol; slightly soluble in chloroform; practically insoluble in ether. TIMOPTIC is stable at room temperature. TIMOPTIC Ophthalmic Solution is supplied as a sterile, isotonic, buffered, aqueous solution of timolol maleate in two dosage strengths. Each mL of TIMOPTIC 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). The pH of the solution is approximately 7, and the osmolality is 260-340 mOsm/kg. Each mL of TIMOPTIC 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: monobasic and dibasic sodium phosphate, sodium hydroxide to adjust pH, and purified water. Benzalkonium chloride 0.01% is added as preservative."
},
{
"NDCCode": "37000-812-01",
"PackageDescription": "30 mL in 1 BOTTLE, PLASTIC (37000-812-01) ",
"NDC11Code": "37000-0812-01",
"ProductNDC": "37000-812",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vicks Nyquil",
"ProprietaryNameSuffix": "Severe Cold And Flu",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, And Phenylephrine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20130722",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "650; 20; 12.5; 10",
"StrengthUnit": "mg/30mL; mg/30mL; mg/30mL; mg/30mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201013",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves common cold/flu symptoms: 1 nasal congestion, 2 sinus congestion & pressure, 3 cough due to minor throat & bronchial irritation, 4 cough to help you sleep, 5 minor aches & pains, 6 headache, 7 fever, 8 sore throat, 9 runny nose & sneezing, 10 reduces swelling of nasal passages, 11 temporarily restores freer breathing through the nose, 12 promotes nasal and/or sinus drainage."
},
{
"NDCCode": "37000-812-04",
"PackageDescription": "4 BOTTLE, PLASTIC in 1 PACKAGE (37000-812-04) / 30 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "37000-0812-04",
"ProductNDC": "37000-812",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vicks Nyquil",
"ProprietaryNameSuffix": "Severe Cold And Flu",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, And Phenylephrine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20130722",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "650; 20; 12.5; 10",
"StrengthUnit": "mg/30mL; mg/30mL; mg/30mL; mg/30mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210713",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves common cold/flu symptoms: 1 nasal congestion, 2 sinus congestion & pressure, 3 cough due to minor throat & bronchial irritation, 4 cough to help you sleep, 5 minor aches & pains, 6 headache, 7 fever, 8 sore throat, 9 runny nose & sneezing, 10 reduces swelling of nasal passages, 11 temporarily restores freer breathing through the nose, 12 promotes nasal and/or sinus drainage."
},
{
"NDCCode": "37000-812-08",
"PackageDescription": "236 mL in 1 BOTTLE, PLASTIC (37000-812-08) ",
"NDC11Code": "37000-0812-08",
"ProductNDC": "37000-812",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vicks Nyquil",
"ProprietaryNameSuffix": "Severe Cold And Flu",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, And Phenylephrine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20130722",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "650; 20; 12.5; 10",
"StrengthUnit": "mg/30mL; mg/30mL; mg/30mL; mg/30mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130722",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves common cold/flu symptoms: 1 nasal congestion, 2 sinus congestion & pressure, 3 cough due to minor throat & bronchial irritation, 4 cough to help you sleep, 5 minor aches & pains, 6 headache, 7 fever, 8 sore throat, 9 runny nose & sneezing, 10 reduces swelling of nasal passages, 11 temporarily restores freer breathing through the nose, 12 promotes nasal and/or sinus drainage."
},
{
"NDCCode": "37000-812-12",
"PackageDescription": "354 mL in 1 BOTTLE, PLASTIC (37000-812-12) ",
"NDC11Code": "37000-0812-12",
"ProductNDC": "37000-812",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vicks Nyquil",
"ProprietaryNameSuffix": "Severe Cold And Flu",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, And Phenylephrine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20130722",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "650; 20; 12.5; 10",
"StrengthUnit": "mg/30mL; mg/30mL; mg/30mL; mg/30mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130722",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves common cold/flu symptoms: 1 nasal congestion, 2 sinus congestion & pressure, 3 cough due to minor throat & bronchial irritation, 4 cough to help you sleep, 5 minor aches & pains, 6 headache, 7 fever, 8 sore throat, 9 runny nose & sneezing, 10 reduces swelling of nasal passages, 11 temporarily restores freer breathing through the nose, 12 promotes nasal and/or sinus drainage."
},
{
"NDCCode": "37000-812-24",
"PackageDescription": "2 BOTTLE, PLASTIC in 1 PACKAGE (37000-812-24) / 354 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "37000-0812-24",
"ProductNDC": "37000-812",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vicks Nyquil",
"ProprietaryNameSuffix": "Severe Cold And Flu",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, And Phenylephrine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20130722",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "650; 20; 12.5; 10",
"StrengthUnit": "mg/30mL; mg/30mL; mg/30mL; mg/30mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130722",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves common cold/flu symptoms: 1 nasal congestion, 2 sinus congestion & pressure, 3 cough due to minor throat & bronchial irritation, 4 cough to help you sleep, 5 minor aches & pains, 6 headache, 7 fever, 8 sore throat, 9 runny nose & sneezing, 10 reduces swelling of nasal passages, 11 temporarily restores freer breathing through the nose, 12 promotes nasal and/or sinus drainage."
},
{
"NDCCode": "42799-812-01",
"PackageDescription": "237 mL in 1 BOTTLE, PLASTIC (42799-812-01) ",
"NDC11Code": "42799-0812-01",
"ProductNDC": "42799-812",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisolone Sodium Phosphate",
"NonProprietaryName": "Prednisolone Sodium Phosphate",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20111111",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203559",
"LabelerName": "Edenbridge Pharmaceuticals LLC.",
"SubstanceName": "PREDNISOLONE SODIUM PHOSPHATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20111111",
"SamplePackage": "N",
"IndicationAndUsage": "Prednisolone Sodium Phosphate Oral Solution (10 mg Prednisolone per 5 mL), Prednisolone Sodium Phosphate Oral Solution (15 mg Prednisolone per 5 mL), Prednisolone Sodium Phosphate Oral Solution (20 mg Prednisolone per 5 mL) and Prednisolone Sodium Phosphate (25 mg Prednisolone per 5 mL) are indicated in the following conditions. 1. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adult and pediatric populations with: seasonal or perennial allergic rhinitis; asthma; contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions. 2. Dermatologic Diseases. Pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative erythroderma; mycosis fungoides. 3. Edematous States. To induce diuresis or remission of proteinuria in nephrotic syndrome in adults with lupus erythematosus and in adults and pediatric populations, with idiopathic nephrotic syndrome, without uremia. 4. Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance); congenital adrenal hyperplasia; hypercalcemia associated with cancer; nonsuppurative thyroiditis. 5. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in: ulcerative colitis; regional enteritis. 6. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adults; selected cases of secondary thrombocytopenia; acquired (autoimmune) hemolytic anemia; pure red cell aplasia; Diamond-Blackfan anemia. 7. Neoplastic Diseases. For the treatment of acute leukemia and aggressive lymphomas in adults and children. 8. Nervous System. Acute exacerbations of multiple sclerosis. 9. Ophthalmic Diseases. Uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids; temporal arteritis; sympathetic ophthalmia. 10. Respiratory Diseases. Symptomatic sarcoidosis; idiopathic eosinophilic pneumonias; fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy; asthma (as distinct from allergic asthma listed above under \"Allergic States\"), hypersensitivity pneumonitis, idiopathic pulmonary fibrosis, acute exacerbations of chronic obstructive pulmonary disease (COPD), and Pneumocystis carinii pneumonia (PCP) associated with hypoxemia occurring in an HIV (+) individual who is also under treatment with appropriate anti-PCP antibiotics. Studies support the efficacy of systemic corticosteroids for the treatment of these conditions: allergic bronchopulmonary aspergillosis, idiopathic bronchiolitis obliterans with organizing pneumonia. 11. Rheumatic Disorders. As adjunctive therapy for short term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low dose maintenance therapy); ankylosing spondylitis; acute and subacute bursitis; acute nonspecific tenosynovitis; acute gouty arthritis; epicondylitis. For the treatment of systemic lupus erythematosus, dermatomyositis (polymyositis), polymyalgia rheumatica, Sjogren's syndrome, relapsing polychondritis, and certain cases of vasculitis. 12. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block, tuberculosis with enlarged mediastinal lymph nodes causing respiratory difficulty, and tuberculosis with pleural or pericardial effusion (appropriate antituberculous chemotherapy must be used concurrently when treating any tuberculosis complications); trichinosis with neurologic or myocardial involvement; acute or chronic solid organ rejection (with or without other agents).",
"Description": "Prednisolone Sodium Phosphate Oral Solution (10 mg Prednisolone per 5 mL), Prednisolone Sodium Phosphate Oral Solution (15 mg Prednisolone per 5 mL), Prednisolone Sodium Phosphate Oral Solution (20 mg Prednisolone per 5 mL) and Prednisolone Sodium Phosphate Oral Solution (25 mg Prednisolone per 5 mL) are dye free, pale to light yellow solutions. Each 5 mL (teaspoonful) of Prednisolone Sodium Phosphate Oral Solution contains 13.4 mg prednisolone sodium phosphate (10 mg prednisolone base),20.2 mg prednisolone sodium phosphate (15 mg prednisolone base), 26.9 mg prednisolone sodium phosphate (20 mg prednisolone base) or 33.6 mg prednisolone sodium phosphate (25 mg prednisolone base) in a palatable, aqueous vehicle. Inactive Ingredients: Prednisolone Sodium Phosphate Oral Solution (10 mg Prednisolone per 5 mL), Prednisolone Sodium Phosphate Oral Solution (15 mg Prednisolone per 5 mL), Prednisolone Sodium Phosphate Oral Solution (20 mg Prednisolone per 5 mL) and Prednisolone Sodium Phosphate Oral Solution (25 mg Prednisolone per 5 mL) contains the following inactive ingredients: anti-bitter mask, corn syrup, edetate disodium, glycerin, grape flavor, hydroxyethylcellulose, methylparaben, potassium phosphate dibasic, potassium phosphate monobasic, purified water, and sodium saccharin. Prednisolone sodium phosphate occurs as white or slightly yellow, friable granules or powder. It is freely soluble in water; soluble in methanol; slightly soluble in alcohol and in chloroform; and very slightly soluble in acetone and in dioxane. The chemical name of prednisolone sodium phosphate is pregna-1,4-diene-3,20-dione,11,17-dihydroxy-21-(phosphonooxy)- disodium salt, (11b)-. The empirical formula is C 21H 27Na 2O 8P; the molecular weight is 484.39. Its chemical structure is:. Pharmacological Category: Glucocorticoid."
},
{
"NDCCode": "42858-812-12",
"PackageDescription": "120 mL in 1 BOTTLE, PLASTIC (42858-812-12) ",
"NDC11Code": "42858-0812-12",
"ProductNDC": "42858-812",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Morphine Sulfate",
"NonProprietaryName": "Morphine Sulfate",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20170622",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206308",
"LabelerName": "Rhodes Pharmaceuticals L.P.",
"SubstanceName": "MORPHINE SULFATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2023-10-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20170622",
"SamplePackage": "N",
"IndicationAndUsage": "Morphine Sulfate Oral Solution is indicated for the management of acute and chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) is indicated for the relief of acute and chronic pain in opioid-tolerant patients. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.2)], reserve Morphine Sulfate Oral Solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]. : 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
"Description": "Morphine Sulfate Oral Solution is an opioid agonist, available in 10 mg per 5 mL (2 mg/mL), 20 mg per 5 mL (4 mg/mL), and 100 mg per 5 mL (20 mg/mL) strengths for oral administration. The chemical name is 7,8-didehydro-4,5 alpha-epoxy-17 methyl-morphinan-3,6 alpha-diol sulfate (2:1) (salt) pentahydrate. The molecular weight is 758.83. Its molecular formula is (C17H21NO3)2∙H2SO4∙5H20, and it has the following chemical structure. Morphine sulfate USP is a white to off-white crystalline powder or a fine white to light yellow powder. It is soluble in water and slightly soluble in alcohol, but is practically insoluble in chloroform or ether. The octanol:water partition coefficient of morphine is 1.42 at physiologic pH and the pKa is 7.9 for the tertiary nitrogen (the majority is ionized at pH 7.4). For the 10 mg per 5 mL (2 mg/mL) strength: Each 5 mL of oral solution contains 10 mg of morphine sulfate, USP and the following inactive ingredients: water, sorbitol solution, glycerin, anhydrous citric acid, sodium benzoate, white chocolate flavor, edetate disodium, FD&C Red No. 40 and if necessary, sodium hydroxide, and/or hydrochloric acid to adjust pH. For the 20 mg per 5 mL (4 mg/mL) strength: Each 5 mL of oral solution contains 20 mg of morphine sulfate, USP and the following inactive ingredients: water, sorbitol solution, glycerin, anhydrous citric acid, methylparaben, propylparaben, sodium benzoate, white chocolate flavor, edetate disodium, FD&C Red No. 40 and if necessary, sodium hydroxide, and/or hydrochloric acid to adjust pH. For the 100 mg per 5 mL (20 mg/mL) strength: Each 5 mL of oral solution contains 100 mg of morphine sulfate, USP and the following inactive ingredients: water, sorbitol solution, glycerin, anhydrous citric acid, sodium benzoate, edetate disodium and if necessary, sodium hydroxide, and/or hydrochloric acid to adjust pH."
},
{
"NDCCode": "42858-812-15",
"PackageDescription": "30 mL in 1 BOTTLE, PLASTIC (42858-812-15) ",
"NDC11Code": "42858-0812-15",
"ProductNDC": "42858-812",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Morphine Sulfate",
"NonProprietaryName": "Morphine Sulfate",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20170622",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206308",
"LabelerName": "Rhodes Pharmaceuticals L.P.",
"SubstanceName": "MORPHINE SULFATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2023-10-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20170622",
"SamplePackage": "N",
"IndicationAndUsage": "Morphine Sulfate Oral Solution is indicated for the management of acute and chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) is indicated for the relief of acute and chronic pain in opioid-tolerant patients. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.2)], reserve Morphine Sulfate Oral Solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]. : 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
"Description": "Morphine Sulfate Oral Solution is an opioid agonist, available in 10 mg per 5 mL (2 mg/mL), 20 mg per 5 mL (4 mg/mL), and 100 mg per 5 mL (20 mg/mL) strengths for oral administration. The chemical name is 7,8-didehydro-4,5 alpha-epoxy-17 methyl-morphinan-3,6 alpha-diol sulfate (2:1) (salt) pentahydrate. The molecular weight is 758.83. Its molecular formula is (C17H21NO3)2∙H2SO4∙5H20, and it has the following chemical structure. Morphine sulfate USP is a white to off-white crystalline powder or a fine white to light yellow powder. It is soluble in water and slightly soluble in alcohol, but is practically insoluble in chloroform or ether. The octanol:water partition coefficient of morphine is 1.42 at physiologic pH and the pKa is 7.9 for the tertiary nitrogen (the majority is ionized at pH 7.4). For the 10 mg per 5 mL (2 mg/mL) strength: Each 5 mL of oral solution contains 10 mg of morphine sulfate, USP and the following inactive ingredients: water, sorbitol solution, glycerin, anhydrous citric acid, sodium benzoate, white chocolate flavor, edetate disodium, FD&C Red No. 40 and if necessary, sodium hydroxide, and/or hydrochloric acid to adjust pH. For the 20 mg per 5 mL (4 mg/mL) strength: Each 5 mL of oral solution contains 20 mg of morphine sulfate, USP and the following inactive ingredients: water, sorbitol solution, glycerin, anhydrous citric acid, methylparaben, propylparaben, sodium benzoate, white chocolate flavor, edetate disodium, FD&C Red No. 40 and if necessary, sodium hydroxide, and/or hydrochloric acid to adjust pH. For the 100 mg per 5 mL (20 mg/mL) strength: Each 5 mL of oral solution contains 100 mg of morphine sulfate, USP and the following inactive ingredients: water, sorbitol solution, glycerin, anhydrous citric acid, sodium benzoate, edetate disodium and if necessary, sodium hydroxide, and/or hydrochloric acid to adjust pH."
},
{
"NDCCode": "54859-812-16",
"PackageDescription": "473 mL in 1 BOTTLE (54859-812-16) ",
"NDC11Code": "54859-0812-16",
"ProductNDC": "54859-812",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Conex",
"NonProprietaryName": "Dexbrompheniramine Maleate, Pseudoephedrine Hcl",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20241201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Llorens Pharmaceutical International Division",
"SubstanceName": "PSEUDOEPHEDRINE HYDROCHLORIDE; DEXBROMPHENIRAMINE MALEATE",
"StrengthNumber": "60; 2",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241201",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. : 1 Temporarily relieves nasal congestion due to the common cold, hay fever or other upper repiratory allergies, 2 helps decongest sinus opening and sinus passages, 3 reduces swelling of nasal passages, shrinks swollen membranes, and temporarily restores freer breathing through the nose, 4 temporarily alleviates the following symptoms due to hay fever (allergic rhinitis), 5 runny nose, 6 sneezing, 7 itching of the nose or throat, 8 ithy and watery eyes."
},
{
"NDCCode": "58160-812-11",
"PackageDescription": "10 VIAL in 1 CARTON (58160-812-11) > .5 mL in 1 VIAL (58160-812-01) ",
"NDC11Code": "58160-0812-11",
"ProductNDC": "58160-812",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Kinrix",
"NonProprietaryName": "Diphtheria And Tetanus Toxoids And Acellular Pertussis Adsorbed And Inactivated Poliovirus Vaccine",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20080709",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125260",
"LabelerName": "GlaxoSmithKline Biologicals SA",
"SubstanceName": "BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED)",
"StrengthNumber": "25; 8; 25; 10; 25; 40; 8; 32",
"StrengthUnit": "[iU]/.5mL; ug/.5mL; ug/.5mL; [iU]/.5mL; [iU]/.5mL; [iU]/.5mL; [iU]/.5mL; [iU]/.5mL",
"Pharm_Classes": "Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Diphtheria Toxoid [CS], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Clostridium Tetani Vaccine [EPC], Inactivated Corynebacterium Diphtheriae Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Poliovirus Vaccines [CS], Poliovirus Vaccines [CS], Poliovirus Vaccines [CS], Tetanus Toxoid [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20080709",
"SamplePackage": "N"
},
{
"NDCCode": "58160-812-52",
"PackageDescription": "10 SYRINGE in 1 CARTON (58160-812-52) / .5 mL in 1 SYRINGE (58160-812-43) ",
"NDC11Code": "58160-0812-52",
"ProductNDC": "58160-812",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Kinrix",
"NonProprietaryName": "Diphtheria And Tetanus Toxoids And Acellular Pertussis Adsorbed And Inactivated Poliovirus Vaccine",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20080709",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125260",
"LabelerName": "GlaxoSmithKline Biologicals SA",
"SubstanceName": "CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED); POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED)",
"StrengthNumber": "25; 10; 25; 8; 25; 40; 8; 32",
"StrengthUnit": "[iU]/.5mL; [iU]/.5mL; [iU]/.5mL; ug/.5mL; ug/.5mL; [iU]/.5mL; [iU]/.5mL; [iU]/.5mL",
"Pharm_Classes": "Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Diphtheria Toxoid [CS], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Clostridium Tetani Vaccine [EPC], Inactivated Corynebacterium Diphtheriae Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Poliovirus Vaccines [CS], Poliovirus Vaccines [CS], Poliovirus Vaccines [CS], Tetanus Toxoid [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS]",
"Status": "Active",
"LastUpdate": "2026-05-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20080709",
"SamplePackage": "N",
"IndicationAndUsage": "A single dose of KINRIX is indicated for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis as the fifth dose in the diphtheria, tetanus, and acellular pertussis (DTaP) vaccine series and the fourth dose in the inactivated poliovirus vaccine (IPV) series in children aged 4 through 6 years (prior to the seventh birthday) whose previous DTaP vaccine doses have been with INFANRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) and/or PEDIARIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine] for the first 3 doses and INFANRIX for the fourth dose.",
"Description": "KINRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine) is a noninfectious, sterile, injectable suspension for intramuscular use. Each 0.5 mL dose is formulated to contain 25 Lf of diphtheria toxoid, 10 Lf of tetanus toxoid, 25 mcg of inactivated pertussis toxin (PT), 25 mcg of filamentous hemagglutinin (FHA), 8 mcg of pertactin (69 kiloDalton outer membrane protein), 40 D‑antigen Units (DU) of Type 1 poliovirus (Mahoney), 8 DU of Type 2 poliovirus (MEF‑1), and 32 DU of Type 3 poliovirus (Saukett). The diphtheria, tetanus, and pertussis components of KINRIX are the same as those in INFANRIX and PEDIARIX and the poliovirus component is the same as that in PEDIARIX. The diphtheria toxin is produced by growing Corynebacterium diphtheriae (C. diphtheriae) in Fenton medium containing a bovine extract. Tetanus toxin is produced by growing Clostridium tetani (C. tetani) in a modified Latham medium derived from bovine casein. The bovine materials used in these extracts are sourced from countries which the United States Department of Agriculture (USDA) has determined neither have nor are at risk of bovine spongiform encephalopathy (BSE). Both toxins are detoxified with formaldehyde, concentrated by ultrafiltration, and purified by precipitation, dialysis, and sterile filtration. The acellular pertussis antigens (PT, FHA, and pertactin) are isolated from Bordetella pertussis (B. pertussis) culture grown in modified Stainer-Scholte liquid medium. PT and FHA are isolated from the fermentation broth; pertactin is extracted from the cells by heat treatment and flocculation. The antigens are purified in successive chromatographic and precipitation steps. PT is detoxified using glutaraldehyde and formaldehyde. FHA and pertactin are treated with formaldehyde. Diphtheria and tetanus toxoids and pertussis antigens (inactivated PT, FHA, and pertactin) are individually adsorbed onto aluminum hydroxide. The inactivated poliovirus component of KINRIX is an enhanced potency component. Each of the 3 strains of poliovirus is individually grown in VERO cells, a continuous line of monkey kidney cells, cultivated on microcarriers. Calf serum and lactalbumin hydrolysate are used during VERO cell culture and/or virus culture. Calf serum is sourced from countries the USDA has determined neither have nor are at risk of BSE. After clarification, each viral suspension is purified by ultrafiltration, diafiltration, and successive chromatographic steps, and inactivated with formaldehyde. The 3 purified viral strains are then pooled to form a trivalent concentrate. Diphtheria and tetanus toxoid potency is determined by measuring the amount of neutralizing antitoxin in previously immunized guinea pigs. The potency of the acellular pertussis components (inactivated PT, FHA, and pertactin) is determined by enzyme-linked immunosorbent assay (ELISA) on sera from previously immunized mice. The potency of the inactivated poliovirus component is determined by using the D-antigen ELISA and by a poliovirus-neutralizing cell culture assay on sera from previously immunized rats. Each 0.5 mL dose contains aluminum hydroxide as adjuvant (formulated to contain 0.5 mg aluminum) and ≤4.4 mg of sodium chloride. The aluminum content is measured by assay. Each dose also contains ≤100 mcg of residual formaldehyde and ≤100 mcg of polysorbate 80 (Tween 80). Neomycin sulfate and polymyxin B sulfate are used in the poliovirus vaccine manufacturing process and may be present in the final vaccine at ≤0.05 ng neomycin and ≤0.01 ng polymyxin B per dose. The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex. KINRIX does not contain a preservative."
},
{
"NDCCode": "59310-812-06",
"PackageDescription": "1 POUCH in 1 CARTON (59310-812-06) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER",
"NDC11Code": "59310-0812-06",
"ProductNDC": "59310-812",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Airduo Respiclick",
"NonProprietaryName": "Fluticasone Propionate And Salmeterol",
"DosageFormName": "POWDER, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20170420",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208799",
"LabelerName": "Teva Respiratory, LLC",
"SubstanceName": "FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE",
"StrengthNumber": "113; 14",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170424",
"SamplePackage": "N",
"IndicationAndUsage": "AIRDUO® RESPICLICK® is indicated for the treatment of asthma in adult and pediatric patients aged 12 years and older. AIRDUO RESPICLICK should be used for patients not adequately controlled on a long term asthma control medication such as an inhaled corticosteroid or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long acting beta2-adrenergic agonist (LABA). Limitations of Use:. AIRDUO RESPICLICK is not indicated for the relief of acute bronchospasm.",
"Description": "AIRDUO RESPICLICK 55 mcg/14 mcg, AIRDUO RESPICLICK 113 mcg/14 mcg and AIRDUO RESPICLICK 232 mcg/14 mcg are combinations of fluticasone propionate and salmeterol. Fluticasone Propionate. One active component of AIRDUO RESPICLICK is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11ß,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17ß-carbothioate, 17-propionate, and the following chemical structure. Fluticasone propionate is a white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. Salmeterol Xinafoate. The other active component of AIRDUO RESPICLICK is salmeterol xinafoate, a beta2–adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1‑hydroxy‑2‑naphthoic acid salt of salmeterol. It has the chemical name 4-hydroxy-α -[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-1,3-benzenedimethanol, 1-hydroxy-2-naphthalenecarboxylate and the following chemical structure. Salmeterol xinafoate is a white powder with a molecular weight of 603.8, and the empirical formula is C25H37NO4C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. AIRDUO RESPICLICK. AIRDUO RESPICLICK is a multidose dry powder inhaler (MDPI) for oral inhalation only. It contains fluticasone propionate, salmeterol xinafoate, and lactose monohydrate (which may contain milk proteins). The opening of the mouthpiece cover meters 5.5 mg of the formulation from the device reservoir, which contains 55 mcg, 113 mcg, or 232 mcg of fluticasone propionate, and 14 mcg of salmeterol base (equivalent to 20.3 mcg of salmeterol xinafoate). Patient inhalation through the mouthpiece causes the deagglomeration and aerosolization of the drug particles as the formulation moves through the cyclone component of the device. This is followed by dispersion into the airstream. Under standardized in vitro test conditions, the AIRDUO RESPICLICK inhaler delivers 49 mcg, 100 mcg, or 202 mcg of fluticasone propionate and 12.75 mcg of salmeterol base (equivalent to 18.5 mcg of salmeterol xinafoate), with lactose from the mouthpiece when tested at a flow rate of 85 L/min for 1.4 seconds. The amount of drug delivered to the lung will depend on patient factors such as inspiratory flow profiles. In adult subjects (N=50, aged 18 to 45 years) with asthma, mean peak inspiratory flow (PIF) through the AIRDUO RESPICLICK inhaler was 108.28 L/min (range: 70.37 to 129.24 L/min). In adolescent subjects (N=50, aged 12 to 17 years) with asthma, mean peak inspiratory flow (PIF) through the AIRDUO RESPICLICK inhaler was 106.72 L/min (range: 73.64 to 125.51 L/min)."
},
{
"NDCCode": "59310-812-08",
"PackageDescription": "1 POUCH in 1 CARTON (59310-812-08) > 1 INHALER in 1 POUCH > 60 POWDER, METERED in 1 INHALER",
"NDC11Code": "59310-0812-08",
"ProductNDC": "59310-812",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Airduo Respiclick",
"NonProprietaryName": "Fluticasone Propionate And Salmeterol",
"DosageFormName": "POWDER, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20170420",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208799",
"LabelerName": "Teva Respiratory, LLC",
"SubstanceName": "FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE",
"StrengthNumber": "113; 14",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-02-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20170420",
"SamplePackage": "N",
"IndicationAndUsage": "AIRDUO® RESPICLICK® is indicated for the treatment of asthma in adult and pediatric patients aged 12 years and older. AIRDUO RESPICLICK should be used for patients not adequately controlled on a long term asthma control medication such as an inhaled corticosteroid or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long acting beta2-adrenergic agonist (LABA). Limitations of Use:. AIRDUO RESPICLICK is not indicated for the relief of acute bronchospasm.",
"Description": "AIRDUO RESPICLICK 55 mcg/14 mcg, AIRDUO RESPICLICK 113 mcg/14 mcg and AIRDUO RESPICLICK 232 mcg/14 mcg are combinations of fluticasone propionate and salmeterol. Fluticasone Propionate. One active component of AIRDUO RESPICLICK is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11ß,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17ß-carbothioate, 17-propionate, and the following chemical structure. Fluticasone propionate is a white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. Salmeterol Xinafoate. The other active component of AIRDUO RESPICLICK is salmeterol xinafoate, a beta2–adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1‑hydroxy‑2‑naphthoic acid salt of salmeterol. It has the chemical name 4-hydroxy-α -[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-1,3-benzenedimethanol, 1-hydroxy-2-naphthalenecarboxylate and the following chemical structure. Salmeterol xinafoate is a white powder with a molecular weight of 603.8, and the empirical formula is C25H37NO4C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. AIRDUO RESPICLICK. AIRDUO RESPICLICK is a multidose dry powder inhaler (MDPI) for oral inhalation only. It contains fluticasone propionate, salmeterol xinafoate, and lactose monohydrate (which may contain milk proteins). The opening of the mouthpiece cover meters 5.5 mg of the formulation from the device reservoir, which contains 55 mcg, 113 mcg, or 232 mcg of fluticasone propionate, and 14 mcg of salmeterol base (equivalent to 20.3 mcg of salmeterol xinafoate). Patient inhalation through the mouthpiece causes the deagglomeration and aerosolization of the drug particles as the formulation moves through the cyclone component of the device. This is followed by dispersion into the airstream. Under standardized in vitro test conditions, the AIRDUO RESPICLICK inhaler delivers 49 mcg, 100 mcg, or 202 mcg of fluticasone propionate and 12.75 mcg of salmeterol base (equivalent to 18.5 mcg of salmeterol xinafoate), with lactose from the mouthpiece when tested at a flow rate of 85 L/min for 1.4 seconds. The amount of drug delivered to the lung will depend on patient factors such as inspiratory flow profiles. In adult subjects (N=50, aged 18 to 45 years) with asthma, mean peak inspiratory flow (PIF) through the AIRDUO RESPICLICK inhaler was 108.28 L/min (range: 70.37 to 129.24 L/min). In adolescent subjects (N=50, aged 12 to 17 years) with asthma, mean peak inspiratory flow (PIF) through the AIRDUO RESPICLICK inhaler was 106.72 L/min (range: 73.64 to 125.51 L/min)."
},
{
"NDCCode": "59651-812-08",
"PackageDescription": "120 CAPSULE in 1 BOTTLE (59651-812-08) ",
"NDC11Code": "59651-0812-08",
"ProductNDC": "59651-812",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Icosapent Ethyl",
"NonProprietaryName": "Icosapent Ethyl",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260624",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218949",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "ICOSAPENT ETHYL",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Status": "Active",
"LastUpdate": "2026-07-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260624",
"SamplePackage": "N",
"IndicationAndUsage": "Icosapent ethyl capsules are indicated: : 1 as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. .",
"Description": "Icosapent ethyl, a lipid-regulating agent, is supplied as a 1 gram amber colored, liquid-filled soft gelatin capsule for oral use. Each icosapent ethyl capsule contains 1 gram of icosapent ethyl (in a 1 gram capsule). Icosapent ethyl is an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA). The molecular formula of icosapent ethyl is C22H34O2 and the molecular weight is 330.51. The chemical name for icosapent ethyl is ethyl allcis-5,8,11,14,17-icosapentaenoate with the following chemical structure:. Icosapent ethyl capsules also contain the following inactive ingredients: Gelatin, glycerin, maltitol solution, non – crystallizing sorbitol solution, purified water and vitamin-E."
},
{
"NDCCode": "60267-812-00",
"PackageDescription": "1 KIT in 1 CARTON (60267-812-00) * 10 mL in 1 VIAL, SINGLE-USE (60267-311-10) * 50 mL in 1 VIAL, SINGLE-DOSE (60267-705-50) ",
"NDC11Code": "60267-0812-00",
"ProductNDC": "60267-812",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nithiodote",
"NonProprietaryName": "Sodium Nitrite And Sodium Thiosulfate",
"DosageFormName": "KIT",
"StartMarketingDate": "20110114",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA201444",
"LabelerName": "Hope Pharmaceuticals",
"Status": "Active",
"LastUpdate": "2025-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110114",
"SamplePackage": "N",
"IndicationAndUsage": "NITHIODOTE is indicated for the treatment of acute cyanide poisoning that is judged to be serious or life-threatening. When the diagnosis of cyanide poisoning is uncertain, carefully weigh the potentially life-threatening risks associated with NITHIODOTE against the potential benefits, especially if the patient is not in extremis.",
"Description": "Sodium nitrite, one of the active ingredients in NITHIODOTE has the chemical name nitrous acid sodium salt. The chemical formula is NaNO2 and the molecular weight is 69.0. Sodium thiosulfate, the second active ingredient in NITHIODOTE has the chemical name thiosulfuric acid, disodium salt, pentahydrate. The chemical formula is Na2S2O3∙ 5H2O and the molecular weight is 248.17. The structural formulae are. Structure of Sodium Nitrite. Structure of Sodium Thiosulfate Pentahydrate. NITHIODOTE is a cyanide antidote which contains one 10 mL glass vial of a 3% solution of sodium nitrite injection and one 50 mL glass vial containing a 25% solution of sodium thiosulfate injection. Sodium nitrite injection is a sterile aqueous solution and is intended for intravenous injection. Each vial contains 300 mg of sodium nitrite in 10 mL solution (30 mg/mL). Sodium nitrite injection is a clear solution with a pH between 7.0 and 9.0. Sodium thiosulfate injection is a sterile aqueous solution and is intended for intravenous injection. Each vial contains 12.5 grams of sodium thiosulfate in 50 mL solution (250 mg/mL). Each mL also contains 2.8 mg boric acid and 4.4 mg of potassium chloride. The pH of the solution is adjusted with boric acid and/or sodium hydroxide. Sodium thiosulfate injection is a clear solution with a pH between 7.5 and 9.0."
},
{
"NDCCode": "60687-812-01",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (60687-812-01) / 1 TABLET in 1 BLISTER PACK (60687-812-11) ",
"NDC11Code": "60687-0812-01",
"ProductNDC": "60687-812",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buspirone Hydrochloride",
"NonProprietaryName": "Buspirone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240307",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078888",
"LabelerName": "American Health Packaging",
"SubstanceName": "BUSPIRONE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2024-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240307",
"SamplePackage": "N",
"IndicationAndUsage": "Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets have been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III 1 as follows:. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 Motor tension Shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle. , 2 Autonomic hyperactivity Sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate. , 3 Apprehensive expectation Anxiety, worry, fear, rumination, and anticipation of misfortune to self or others. , 4 Vigilance and scanning Hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling \"on edge,\" irritability, impatience. .",
"Description": "Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride, USP is a white crystalline powder. It is very soluble in water; freely soluble in methanol and in methylene chloride; sparingly soluble in ethanol and in acetonitrile; very slightly soluble in ethyl acetate and practically insoluble in hexanes. Its molecular weight is 422. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The molecular formula C 21H 31N 5O 2HCl is represented by the following structural formula:. Each buspirone hydrochloride tablet intended for oral administration contains 5 mg or 7.5 mg or 10 mg or 15 mg or 30 mg buspirone hydrochloride (equivalent to 4.6 mg, 6.85 mg, 9.1 mg, 13.7 mg, and 27.4 mg of buspirone free base, respectively). In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg and 30 mg tablets are scored so they can be either bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one half of a tablet), or 5 mg (one third of a tablet). A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two thirds of a tablet), 15 mg (one half of a tablet), or 10 mg (one third of a tablet)."
},
{
"NDCCode": "61047-812-73",
"PackageDescription": "236 mL in 1 TUBE (61047-812-73)",
"NDC11Code": "61047-0812-73",
"ProductNDC": "61047-812",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Banana Boat Ultra Defense Sheer Protect",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100319",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "KIK Custom Products",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "2.36; 23.6; 11.8; 1.88; 9.44",
"StrengthUnit": "mL/236mL; mL/236mL; mL/236mL; mL/236mL; mL/236mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "63187-812-07",
"PackageDescription": "7 TABLET, FILM COATED in 1 BOTTLE (63187-812-07) ",
"NDC11Code": "63187-0812-07",
"ProductNDC": "63187-812",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160722",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090478",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Active",
"LastUpdate": "2022-04-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210514",
"SamplePackage": "N",
"IndicationAndUsage": "Cyclobenzaprine HCl tablets USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine HCl should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine HCl has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
"Description": "Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C20H21NHCl and a molecular weight of 311.9. It has a melting point of 217˚C, and a pKa of 8.47 at 25˚C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl, USP is designated chemically as 3-(5H –dibenzo[a,d]cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine HCl USP, 5 mg is supplied as a 5 mg tablet for oral administration. Cyclobenzaprine HCl USP, 10 mg is supplied as a 10 mg tablet for oral administration. Cyclobenzaprine HCl tablets USP, 5 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry beige (hypromellose 6cP, titanium dioxide, PEG 400, iron oxide yellow and iron oxide red). Cyclobenzaprine HCl tablets USP, 10 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry yellow (hypromellose 3cp, hypromellose 6cp, titanium dioxide, PEG 400, iron oxide yellow and polysorbate 80)."
},
{
"NDCCode": "63187-812-10",
"PackageDescription": "10 TABLET, FILM COATED in 1 BOTTLE (63187-812-10) ",
"NDC11Code": "63187-0812-10",
"ProductNDC": "63187-812",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160722",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090478",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Active",
"LastUpdate": "2022-04-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170801",
"SamplePackage": "N",
"IndicationAndUsage": "Cyclobenzaprine HCl tablets USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine HCl should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine HCl has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
"Description": "Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C20H21NHCl and a molecular weight of 311.9. It has a melting point of 217˚C, and a pKa of 8.47 at 25˚C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl, USP is designated chemically as 3-(5H –dibenzo[a,d]cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine HCl USP, 5 mg is supplied as a 5 mg tablet for oral administration. Cyclobenzaprine HCl USP, 10 mg is supplied as a 10 mg tablet for oral administration. Cyclobenzaprine HCl tablets USP, 5 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry beige (hypromellose 6cP, titanium dioxide, PEG 400, iron oxide yellow and iron oxide red). Cyclobenzaprine HCl tablets USP, 10 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry yellow (hypromellose 3cp, hypromellose 6cp, titanium dioxide, PEG 400, iron oxide yellow and polysorbate 80)."
},
{
"NDCCode": "63187-812-12",
"PackageDescription": "12 TABLET, FILM COATED in 1 BOTTLE (63187-812-12) ",
"NDC11Code": "63187-0812-12",
"ProductNDC": "63187-812",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160722",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090478",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Active",
"LastUpdate": "2022-04-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180402",
"SamplePackage": "N",
"IndicationAndUsage": "Cyclobenzaprine HCl tablets USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine HCl should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine HCl has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
"Description": "Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C20H21NHCl and a molecular weight of 311.9. It has a melting point of 217˚C, and a pKa of 8.47 at 25˚C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl, USP is designated chemically as 3-(5H –dibenzo[a,d]cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine HCl USP, 5 mg is supplied as a 5 mg tablet for oral administration. Cyclobenzaprine HCl USP, 10 mg is supplied as a 10 mg tablet for oral administration. Cyclobenzaprine HCl tablets USP, 5 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry beige (hypromellose 6cP, titanium dioxide, PEG 400, iron oxide yellow and iron oxide red). Cyclobenzaprine HCl tablets USP, 10 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry yellow (hypromellose 3cp, hypromellose 6cp, titanium dioxide, PEG 400, iron oxide yellow and polysorbate 80)."
},
{
"NDCCode": "63187-812-15",
"PackageDescription": "15 TABLET, FILM COATED in 1 BOTTLE (63187-812-15) ",
"NDC11Code": "63187-0812-15",
"ProductNDC": "63187-812",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160722",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090478",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Active",
"LastUpdate": "2022-04-14",
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"ProductNdcExcludeFlag": "N",
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"IndicationAndUsage": "Cyclobenzaprine HCl tablets USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine HCl should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine HCl has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
"Description": "Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C20H21NHCl and a molecular weight of 311.9. It has a melting point of 217˚C, and a pKa of 8.47 at 25˚C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl, USP is designated chemically as 3-(5H –dibenzo[a,d]cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine HCl USP, 5 mg is supplied as a 5 mg tablet for oral administration. Cyclobenzaprine HCl USP, 10 mg is supplied as a 10 mg tablet for oral administration. Cyclobenzaprine HCl tablets USP, 5 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry beige (hypromellose 6cP, titanium dioxide, PEG 400, iron oxide yellow and iron oxide red). Cyclobenzaprine HCl tablets USP, 10 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry yellow (hypromellose 3cp, hypromellose 6cp, titanium dioxide, PEG 400, iron oxide yellow and polysorbate 80)."
},
{
"NDCCode": "63187-812-20",
"PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE (63187-812-20) ",
"NDC11Code": "63187-0812-20",
"ProductNDC": "63187-812",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160722",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090478",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Active",
"LastUpdate": "2022-04-14",
"PackageNdcExcludeFlag": "N",
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"IndicationAndUsage": "Cyclobenzaprine HCl tablets USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine HCl should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine HCl has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
"Description": "Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C20H21NHCl and a molecular weight of 311.9. It has a melting point of 217˚C, and a pKa of 8.47 at 25˚C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl, USP is designated chemically as 3-(5H –dibenzo[a,d]cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine HCl USP, 5 mg is supplied as a 5 mg tablet for oral administration. Cyclobenzaprine HCl USP, 10 mg is supplied as a 10 mg tablet for oral administration. Cyclobenzaprine HCl tablets USP, 5 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry beige (hypromellose 6cP, titanium dioxide, PEG 400, iron oxide yellow and iron oxide red). Cyclobenzaprine HCl tablets USP, 10 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry yellow (hypromellose 3cp, hypromellose 6cp, titanium dioxide, PEG 400, iron oxide yellow and polysorbate 80)."
},
{
"NDCCode": "63187-812-21",
"PackageDescription": "21 TABLET, FILM COATED in 1 BOTTLE (63187-812-21) ",
"NDC11Code": "63187-0812-21",
"ProductNDC": "63187-812",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160722",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090478",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
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"LastUpdate": "2022-04-14",
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"IndicationAndUsage": "Cyclobenzaprine HCl tablets USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine HCl should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine HCl has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
"Description": "Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C20H21NHCl and a molecular weight of 311.9. It has a melting point of 217˚C, and a pKa of 8.47 at 25˚C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl, USP is designated chemically as 3-(5H –dibenzo[a,d]cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine HCl USP, 5 mg is supplied as a 5 mg tablet for oral administration. Cyclobenzaprine HCl USP, 10 mg is supplied as a 10 mg tablet for oral administration. Cyclobenzaprine HCl tablets USP, 5 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry beige (hypromellose 6cP, titanium dioxide, PEG 400, iron oxide yellow and iron oxide red). Cyclobenzaprine HCl tablets USP, 10 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry yellow (hypromellose 3cp, hypromellose 6cp, titanium dioxide, PEG 400, iron oxide yellow and polysorbate 80)."
},
{
"NDCCode": "63187-812-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (63187-812-30) ",
"NDC11Code": "63187-0812-30",
"ProductNDC": "63187-812",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160722",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090478",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Active",
"LastUpdate": "2022-04-14",
"PackageNdcExcludeFlag": "N",
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"ListingRecordCertifiedThrough": "20271231",
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"IndicationAndUsage": "Cyclobenzaprine HCl tablets USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine HCl should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine HCl has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
"Description": "Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C20H21NHCl and a molecular weight of 311.9. It has a melting point of 217˚C, and a pKa of 8.47 at 25˚C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl, USP is designated chemically as 3-(5H –dibenzo[a,d]cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine HCl USP, 5 mg is supplied as a 5 mg tablet for oral administration. Cyclobenzaprine HCl USP, 10 mg is supplied as a 10 mg tablet for oral administration. Cyclobenzaprine HCl tablets USP, 5 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry beige (hypromellose 6cP, titanium dioxide, PEG 400, iron oxide yellow and iron oxide red). Cyclobenzaprine HCl tablets USP, 10 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry yellow (hypromellose 3cp, hypromellose 6cp, titanium dioxide, PEG 400, iron oxide yellow and polysorbate 80)."
}
]
}
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<NDCList>
<NDC>
<NDCCode>58118-0812-8</NDCCode>
<PackageDescription>30 CAPSULE in 1 BLISTER PACK (58118-0812-8)</PackageDescription>
<NDC11Code>58118-0812-08</NDC11Code>
<ProductNDC>58118-0812</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170727</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090705</ApplicationNumber>
<LabelerName>Clinical Solutions Wholesale, LLC</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-11-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>11822-0812-8</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (11822-0812-8) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>11822-0812-08</NDC11Code>
<ProductNDC>11822-0812</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pain Relief</ProprietaryName>
<ProprietaryNameSuffix>Extra Strength</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19930402</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Rite Aid Corporation</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<EndMarketingDatePackage>20240923</EndMarketingDatePackage>
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<IndicationAndUsage>temporarily relieves minor aches and pains due to:headachemuscular achesbackachethe common coldtoothacheminor pain of arthritispremenstrual and menstrual cramps. temporarily reduces fever.</IndicationAndUsage>
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<NDC>
<NDCCode>60905-0812-0</NDCCode>
<PackageDescription>8.8 mL in 1 BOTTLE (60905-0812-0) </PackageDescription>
<NDC11Code>60905-0812-00</NDC11Code>
<ProductNDC>60905-0812</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Teint Couture Everwear 24h Wear Satin Finish Full Coverage And Comfort Broad Spectrum Spf 20 P200</ProprietaryName>
<NonProprietaryName>Octinoxate, Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>LVMH Fragrance Brands</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>30; 17.5</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190401</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>helps prevent sunburn if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>80491-0812-8</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (80491-0812-8) / 10 TABLET, FILM COATED in 1 BLISTER PACK (80491-0812-7) </PackageDescription>
<NDC11Code>80491-0812-08</NDC11Code>
<ProductNDC>80491-0812</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tryvio</ProprietaryName>
<NonProprietaryName>Aprocitentan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240320</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA217686</ApplicationNumber>
<LabelerName>Idorsia Pharmaceuticals Ltd</LabelerName>
<SubstanceName>APROCITENTAN</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-06-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240320</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TRYVIO, in combination with other antihypertensive drugs, is indicated for the treatment of hypertension, to lower blood pressure (BP) in adult patients who are not adequately controlled on other drugs. Lowering BP reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes. There are no controlled trials demonstrating reduction of risk of these events with TRYVIO. Control of high BP should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve BP goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is BP reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher BPs, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from BP 2 reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower BP goal.</IndicationAndUsage>
<Description>TRYVIO (aprocitentan) is an ERA. The chemical name of aprocitentan is N-[5-(4-bromophenyl)-6- [2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-sulfamide. It has a molecular formula of C16H14Br2N6O4S and a molecular weight of 546.2 g/mol. The structural formula is. Aprocitentan is a white to off-white powder that is insoluble in water. TRYVIO is available as film-coated 12.5 mg strength tablets for oral administration. The inactive ingredients in TRYVIO are croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The film coating contains the following inactive ingredients: hydroxypropyl cellulose, iron oxide black, iron oxide red, iron oxide yellow, polyvinyl alcohol, silica colloidal hydrated, talc, titanium dioxide, and triethyl citrate.</Description>
</NDC>
<NDC>
<NDCCode>16110-812-30</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (16110-812-30) > 30 g in 1 TUBE</PackageDescription>
<NDC11Code>16110-0812-30</NDC11Code>
<ProductNDC>16110-812</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluoroplex</ProprietaryName>
<NonProprietaryName>Fluorouracil</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19931203</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA016988</ApplicationNumber>
<LabelerName>Almirall, LLC</LabelerName>
<SubstanceName>FLUOROURACIL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19931203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FLUOROPLEX Cream is indicated for the topical treatment of multiple actinic (solar) keratoses.</IndicationAndUsage>
<Description>FLUOROPLEX® (fluorouracil) 1% Topical Cream is an antineoplastic/antimetabolite product for dermatological use. Fluorouracil has the empirical formula C4H3FN2O2 and a molecular weight of 130.08. It is sparingly soluble in water and slightly soluble in alcohol. The pH is approximately 8.5. Structural Formula. Fluorouracil. Chemical Name:2,4(1H,3H)-Pyrimidinedione, 5-fluoro-. FLUOROPLEX 1% Topical Cream contains. Active Ingredient: fluorouracil 1.0%. Inactive Ingredients: benzyl alcohol, emulsifying wax, isopropyl myristate, mineral oil, purified water, and sodium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>24208-812-05</NDCCode>
<PackageDescription>1 BOTTLE, DISPENSING in 1 CARTON (24208-812-05) > 5 mL in 1 BOTTLE, DISPENSING</PackageDescription>
<NDC11Code>24208-0812-05</NDC11Code>
<ProductNDC>24208-812</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Timoptic</ProprietaryName>
<NonProprietaryName>Timolol Maleate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20161230</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018086</ApplicationNumber>
<LabelerName>Bausch & Lomb Incorporated</LabelerName>
<SubstanceName>TIMOLOL MALEATE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-09-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161230</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TIMOPTIC Ophthalmic Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.</IndicationAndUsage>
<Description>TIMOPTIC® (timolol maleate ophthalmic solution) is a non-selective beta-adrenergic receptor blocking agent. Its chemical name is (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. The optical rotation of timolol maleate is. Its molecular formula is C13H24N4O3SC4H4O4 and its structural formula is. Timolol maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water; sparingly soluble in ethanol; slightly soluble in chloroform; practically insoluble in ether. TIMOPTIC is stable at room temperature. TIMOPTIC Ophthalmic Solution is supplied as a sterile, isotonic, buffered, aqueous solution of timolol maleate in two dosage strengths. Each mL of TIMOPTIC 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). The pH of the solution is approximately 7, and the osmolality is 260-340 mOsm/kg. Each mL of TIMOPTIC 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: monobasic and dibasic sodium phosphate, sodium hydroxide to adjust pH, and purified water. Benzalkonium chloride 0.01% is added as preservative.</Description>
</NDC>
<NDC>
<NDCCode>37000-812-01</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, PLASTIC (37000-812-01) </PackageDescription>
<NDC11Code>37000-0812-01</NDC11Code>
<ProductNDC>37000-812</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vicks Nyquil</ProprietaryName>
<ProprietaryNameSuffix>Severe Cold And Flu</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, And Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130722</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>The Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>650; 20; 12.5; 10</StrengthNumber>
<StrengthUnit>mg/30mL; mg/30mL; mg/30mL; mg/30mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201013</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves common cold/flu symptoms: 1 nasal congestion, 2 sinus congestion & pressure, 3 cough due to minor throat & bronchial irritation, 4 cough to help you sleep, 5 minor aches & pains, 6 headache, 7 fever, 8 sore throat, 9 runny nose & sneezing, 10 reduces swelling of nasal passages, 11 temporarily restores freer breathing through the nose, 12 promotes nasal and/or sinus drainage.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>37000-812-04</NDCCode>
<PackageDescription>4 BOTTLE, PLASTIC in 1 PACKAGE (37000-812-04) / 30 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>37000-0812-04</NDC11Code>
<ProductNDC>37000-812</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vicks Nyquil</ProprietaryName>
<ProprietaryNameSuffix>Severe Cold And Flu</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, And Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130722</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>The Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>650; 20; 12.5; 10</StrengthNumber>
<StrengthUnit>mg/30mL; mg/30mL; mg/30mL; mg/30mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210713</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves common cold/flu symptoms: 1 nasal congestion, 2 sinus congestion & pressure, 3 cough due to minor throat & bronchial irritation, 4 cough to help you sleep, 5 minor aches & pains, 6 headache, 7 fever, 8 sore throat, 9 runny nose & sneezing, 10 reduces swelling of nasal passages, 11 temporarily restores freer breathing through the nose, 12 promotes nasal and/or sinus drainage.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>37000-812-08</NDCCode>
<PackageDescription>236 mL in 1 BOTTLE, PLASTIC (37000-812-08) </PackageDescription>
<NDC11Code>37000-0812-08</NDC11Code>
<ProductNDC>37000-812</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vicks Nyquil</ProprietaryName>
<ProprietaryNameSuffix>Severe Cold And Flu</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, And Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130722</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>The Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>650; 20; 12.5; 10</StrengthNumber>
<StrengthUnit>mg/30mL; mg/30mL; mg/30mL; mg/30mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130722</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves common cold/flu symptoms: 1 nasal congestion, 2 sinus congestion & pressure, 3 cough due to minor throat & bronchial irritation, 4 cough to help you sleep, 5 minor aches & pains, 6 headache, 7 fever, 8 sore throat, 9 runny nose & sneezing, 10 reduces swelling of nasal passages, 11 temporarily restores freer breathing through the nose, 12 promotes nasal and/or sinus drainage.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>37000-812-12</NDCCode>
<PackageDescription>354 mL in 1 BOTTLE, PLASTIC (37000-812-12) </PackageDescription>
<NDC11Code>37000-0812-12</NDC11Code>
<ProductNDC>37000-812</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vicks Nyquil</ProprietaryName>
<ProprietaryNameSuffix>Severe Cold And Flu</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, And Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130722</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>The Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>650; 20; 12.5; 10</StrengthNumber>
<StrengthUnit>mg/30mL; mg/30mL; mg/30mL; mg/30mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130722</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves common cold/flu symptoms: 1 nasal congestion, 2 sinus congestion & pressure, 3 cough due to minor throat & bronchial irritation, 4 cough to help you sleep, 5 minor aches & pains, 6 headache, 7 fever, 8 sore throat, 9 runny nose & sneezing, 10 reduces swelling of nasal passages, 11 temporarily restores freer breathing through the nose, 12 promotes nasal and/or sinus drainage.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>37000-812-24</NDCCode>
<PackageDescription>2 BOTTLE, PLASTIC in 1 PACKAGE (37000-812-24) / 354 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>37000-0812-24</NDC11Code>
<ProductNDC>37000-812</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vicks Nyquil</ProprietaryName>
<ProprietaryNameSuffix>Severe Cold And Flu</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, And Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130722</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>The Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>650; 20; 12.5; 10</StrengthNumber>
<StrengthUnit>mg/30mL; mg/30mL; mg/30mL; mg/30mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130722</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves common cold/flu symptoms: 1 nasal congestion, 2 sinus congestion & pressure, 3 cough due to minor throat & bronchial irritation, 4 cough to help you sleep, 5 minor aches & pains, 6 headache, 7 fever, 8 sore throat, 9 runny nose & sneezing, 10 reduces swelling of nasal passages, 11 temporarily restores freer breathing through the nose, 12 promotes nasal and/or sinus drainage.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42799-812-01</NDCCode>
<PackageDescription>237 mL in 1 BOTTLE, PLASTIC (42799-812-01) </PackageDescription>
<NDC11Code>42799-0812-01</NDC11Code>
<ProductNDC>42799-812</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prednisolone Sodium Phosphate</ProprietaryName>
<NonProprietaryName>Prednisolone Sodium Phosphate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111111</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203559</ApplicationNumber>
<LabelerName>Edenbridge Pharmaceuticals LLC.</LabelerName>
<SubstanceName>PREDNISOLONE SODIUM PHOSPHATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111111</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Prednisolone Sodium Phosphate Oral Solution (10 mg Prednisolone per 5 mL), Prednisolone Sodium Phosphate Oral Solution (15 mg Prednisolone per 5 mL), Prednisolone Sodium Phosphate Oral Solution (20 mg Prednisolone per 5 mL) and Prednisolone Sodium Phosphate (25 mg Prednisolone per 5 mL) are indicated in the following conditions. 1. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adult and pediatric populations with: seasonal or perennial allergic rhinitis; asthma; contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions. 2. Dermatologic Diseases. Pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative erythroderma; mycosis fungoides. 3. Edematous States. To induce diuresis or remission of proteinuria in nephrotic syndrome in adults with lupus erythematosus and in adults and pediatric populations, with idiopathic nephrotic syndrome, without uremia. 4. Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance); congenital adrenal hyperplasia; hypercalcemia associated with cancer; nonsuppurative thyroiditis. 5. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in: ulcerative colitis; regional enteritis. 6. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adults; selected cases of secondary thrombocytopenia; acquired (autoimmune) hemolytic anemia; pure red cell aplasia; Diamond-Blackfan anemia. 7. Neoplastic Diseases. For the treatment of acute leukemia and aggressive lymphomas in adults and children. 8. Nervous System. Acute exacerbations of multiple sclerosis. 9. Ophthalmic Diseases. Uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids; temporal arteritis; sympathetic ophthalmia. 10. Respiratory Diseases. Symptomatic sarcoidosis; idiopathic eosinophilic pneumonias; fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy; asthma (as distinct from allergic asthma listed above under "Allergic States"), hypersensitivity pneumonitis, idiopathic pulmonary fibrosis, acute exacerbations of chronic obstructive pulmonary disease (COPD), and Pneumocystis carinii pneumonia (PCP) associated with hypoxemia occurring in an HIV (+) individual who is also under treatment with appropriate anti-PCP antibiotics. Studies support the efficacy of systemic corticosteroids for the treatment of these conditions: allergic bronchopulmonary aspergillosis, idiopathic bronchiolitis obliterans with organizing pneumonia. 11. Rheumatic Disorders. As adjunctive therapy for short term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low dose maintenance therapy); ankylosing spondylitis; acute and subacute bursitis; acute nonspecific tenosynovitis; acute gouty arthritis; epicondylitis. For the treatment of systemic lupus erythematosus, dermatomyositis (polymyositis), polymyalgia rheumatica, Sjogren's syndrome, relapsing polychondritis, and certain cases of vasculitis. 12. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block, tuberculosis with enlarged mediastinal lymph nodes causing respiratory difficulty, and tuberculosis with pleural or pericardial effusion (appropriate antituberculous chemotherapy must be used concurrently when treating any tuberculosis complications); trichinosis with neurologic or myocardial involvement; acute or chronic solid organ rejection (with or without other agents).</IndicationAndUsage>
<Description>Prednisolone Sodium Phosphate Oral Solution (10 mg Prednisolone per 5 mL), Prednisolone Sodium Phosphate Oral Solution (15 mg Prednisolone per 5 mL), Prednisolone Sodium Phosphate Oral Solution (20 mg Prednisolone per 5 mL) and Prednisolone Sodium Phosphate Oral Solution (25 mg Prednisolone per 5 mL) are dye free, pale to light yellow solutions. Each 5 mL (teaspoonful) of Prednisolone Sodium Phosphate Oral Solution contains 13.4 mg prednisolone sodium phosphate (10 mg prednisolone base),20.2 mg prednisolone sodium phosphate (15 mg prednisolone base), 26.9 mg prednisolone sodium phosphate (20 mg prednisolone base) or 33.6 mg prednisolone sodium phosphate (25 mg prednisolone base) in a palatable, aqueous vehicle. Inactive Ingredients: Prednisolone Sodium Phosphate Oral Solution (10 mg Prednisolone per 5 mL), Prednisolone Sodium Phosphate Oral Solution (15 mg Prednisolone per 5 mL), Prednisolone Sodium Phosphate Oral Solution (20 mg Prednisolone per 5 mL) and Prednisolone Sodium Phosphate Oral Solution (25 mg Prednisolone per 5 mL) contains the following inactive ingredients: anti-bitter mask, corn syrup, edetate disodium, glycerin, grape flavor, hydroxyethylcellulose, methylparaben, potassium phosphate dibasic, potassium phosphate monobasic, purified water, and sodium saccharin. Prednisolone sodium phosphate occurs as white or slightly yellow, friable granules or powder. It is freely soluble in water; soluble in methanol; slightly soluble in alcohol and in chloroform; and very slightly soluble in acetone and in dioxane. The chemical name of prednisolone sodium phosphate is pregna-1,4-diene-3,20-dione,11,17-dihydroxy-21-(phosphonooxy)- disodium salt, (11b)-. The empirical formula is C 21H 27Na 2O 8P; the molecular weight is 484.39. Its chemical structure is:. Pharmacological Category: Glucocorticoid.</Description>
</NDC>
<NDC>
<NDCCode>42858-812-12</NDCCode>
<PackageDescription>120 mL in 1 BOTTLE, PLASTIC (42858-812-12) </PackageDescription>
<NDC11Code>42858-0812-12</NDC11Code>
<ProductNDC>42858-812</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Morphine Sulfate</ProprietaryName>
<NonProprietaryName>Morphine Sulfate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170622</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206308</ApplicationNumber>
<LabelerName>Rhodes Pharmaceuticals L.P.</LabelerName>
<SubstanceName>MORPHINE SULFATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2023-10-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170622</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Morphine Sulfate Oral Solution is indicated for the management of acute and chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) is indicated for the relief of acute and chronic pain in opioid-tolerant patients. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.2)], reserve Morphine Sulfate Oral Solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]. : 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Morphine Sulfate Oral Solution is an opioid agonist, available in 10 mg per 5 mL (2 mg/mL), 20 mg per 5 mL (4 mg/mL), and 100 mg per 5 mL (20 mg/mL) strengths for oral administration. The chemical name is 7,8-didehydro-4,5 alpha-epoxy-17 methyl-morphinan-3,6 alpha-diol sulfate (2:1) (salt) pentahydrate. The molecular weight is 758.83. Its molecular formula is (C17H21NO3)2∙H2SO4∙5H20, and it has the following chemical structure. Morphine sulfate USP is a white to off-white crystalline powder or a fine white to light yellow powder. It is soluble in water and slightly soluble in alcohol, but is practically insoluble in chloroform or ether. The octanol:water partition coefficient of morphine is 1.42 at physiologic pH and the pKa is 7.9 for the tertiary nitrogen (the majority is ionized at pH 7.4). For the 10 mg per 5 mL (2 mg/mL) strength: Each 5 mL of oral solution contains 10 mg of morphine sulfate, USP and the following inactive ingredients: water, sorbitol solution, glycerin, anhydrous citric acid, sodium benzoate, white chocolate flavor, edetate disodium, FD&C Red No. 40 and if necessary, sodium hydroxide, and/or hydrochloric acid to adjust pH. For the 20 mg per 5 mL (4 mg/mL) strength: Each 5 mL of oral solution contains 20 mg of morphine sulfate, USP and the following inactive ingredients: water, sorbitol solution, glycerin, anhydrous citric acid, methylparaben, propylparaben, sodium benzoate, white chocolate flavor, edetate disodium, FD&C Red No. 40 and if necessary, sodium hydroxide, and/or hydrochloric acid to adjust pH. For the 100 mg per 5 mL (20 mg/mL) strength: Each 5 mL of oral solution contains 100 mg of morphine sulfate, USP and the following inactive ingredients: water, sorbitol solution, glycerin, anhydrous citric acid, sodium benzoate, edetate disodium and if necessary, sodium hydroxide, and/or hydrochloric acid to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>42858-812-15</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, PLASTIC (42858-812-15) </PackageDescription>
<NDC11Code>42858-0812-15</NDC11Code>
<ProductNDC>42858-812</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Morphine Sulfate</ProprietaryName>
<NonProprietaryName>Morphine Sulfate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170622</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206308</ApplicationNumber>
<LabelerName>Rhodes Pharmaceuticals L.P.</LabelerName>
<SubstanceName>MORPHINE SULFATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2023-10-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170622</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Morphine Sulfate Oral Solution is indicated for the management of acute and chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) is indicated for the relief of acute and chronic pain in opioid-tolerant patients. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.2)], reserve Morphine Sulfate Oral Solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]. : 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Morphine Sulfate Oral Solution is an opioid agonist, available in 10 mg per 5 mL (2 mg/mL), 20 mg per 5 mL (4 mg/mL), and 100 mg per 5 mL (20 mg/mL) strengths for oral administration. The chemical name is 7,8-didehydro-4,5 alpha-epoxy-17 methyl-morphinan-3,6 alpha-diol sulfate (2:1) (salt) pentahydrate. The molecular weight is 758.83. Its molecular formula is (C17H21NO3)2∙H2SO4∙5H20, and it has the following chemical structure. Morphine sulfate USP is a white to off-white crystalline powder or a fine white to light yellow powder. It is soluble in water and slightly soluble in alcohol, but is practically insoluble in chloroform or ether. The octanol:water partition coefficient of morphine is 1.42 at physiologic pH and the pKa is 7.9 for the tertiary nitrogen (the majority is ionized at pH 7.4). For the 10 mg per 5 mL (2 mg/mL) strength: Each 5 mL of oral solution contains 10 mg of morphine sulfate, USP and the following inactive ingredients: water, sorbitol solution, glycerin, anhydrous citric acid, sodium benzoate, white chocolate flavor, edetate disodium, FD&C Red No. 40 and if necessary, sodium hydroxide, and/or hydrochloric acid to adjust pH. For the 20 mg per 5 mL (4 mg/mL) strength: Each 5 mL of oral solution contains 20 mg of morphine sulfate, USP and the following inactive ingredients: water, sorbitol solution, glycerin, anhydrous citric acid, methylparaben, propylparaben, sodium benzoate, white chocolate flavor, edetate disodium, FD&C Red No. 40 and if necessary, sodium hydroxide, and/or hydrochloric acid to adjust pH. For the 100 mg per 5 mL (20 mg/mL) strength: Each 5 mL of oral solution contains 100 mg of morphine sulfate, USP and the following inactive ingredients: water, sorbitol solution, glycerin, anhydrous citric acid, sodium benzoate, edetate disodium and if necessary, sodium hydroxide, and/or hydrochloric acid to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>54859-812-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (54859-812-16) </PackageDescription>
<NDC11Code>54859-0812-16</NDC11Code>
<ProductNDC>54859-812</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Conex</ProprietaryName>
<NonProprietaryName>Dexbrompheniramine Maleate, Pseudoephedrine Hcl</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Llorens Pharmaceutical International Division</LabelerName>
<SubstanceName>PSEUDOEPHEDRINE HYDROCHLORIDE; DEXBROMPHENIRAMINE MALEATE</SubstanceName>
<StrengthNumber>60; 2</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. : 1 Temporarily relieves nasal congestion due to the common cold, hay fever or other upper repiratory allergies, 2 helps decongest sinus opening and sinus passages, 3 reduces swelling of nasal passages, shrinks swollen membranes, and temporarily restores freer breathing through the nose, 4 temporarily alleviates the following symptoms due to hay fever (allergic rhinitis), 5 runny nose, 6 sneezing, 7 itching of the nose or throat, 8 ithy and watery eyes.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58160-812-11</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (58160-812-11) > .5 mL in 1 VIAL (58160-812-01) </PackageDescription>
<NDC11Code>58160-0812-11</NDC11Code>
<ProductNDC>58160-812</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Kinrix</ProprietaryName>
<NonProprietaryName>Diphtheria And Tetanus Toxoids And Acellular Pertussis Adsorbed And Inactivated Poliovirus Vaccine</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20080709</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125260</ApplicationNumber>
<LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
<SubstanceName>BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
<StrengthNumber>25; 8; 25; 10; 25; 40; 8; 32</StrengthNumber>
<StrengthUnit>[iU]/.5mL; ug/.5mL; ug/.5mL; [iU]/.5mL; [iU]/.5mL; [iU]/.5mL; [iU]/.5mL; [iU]/.5mL</StrengthUnit>
<Pharm_Classes>Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Diphtheria Toxoid [CS], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Clostridium Tetani Vaccine [EPC], Inactivated Corynebacterium Diphtheriae Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Poliovirus Vaccines [CS], Poliovirus Vaccines [CS], Poliovirus Vaccines [CS], Tetanus Toxoid [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080709</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>58160-812-52</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (58160-812-52) / .5 mL in 1 SYRINGE (58160-812-43) </PackageDescription>
<NDC11Code>58160-0812-52</NDC11Code>
<ProductNDC>58160-812</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Kinrix</ProprietaryName>
<NonProprietaryName>Diphtheria And Tetanus Toxoids And Acellular Pertussis Adsorbed And Inactivated Poliovirus Vaccine</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20080709</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125260</ApplicationNumber>
<LabelerName>GlaxoSmithKline Biologicals SA</LabelerName>
<SubstanceName>CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED); POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
<StrengthNumber>25; 10; 25; 8; 25; 40; 8; 32</StrengthNumber>
<StrengthUnit>[iU]/.5mL; [iU]/.5mL; [iU]/.5mL; ug/.5mL; ug/.5mL; [iU]/.5mL; [iU]/.5mL; [iU]/.5mL</StrengthUnit>
<Pharm_Classes>Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Diphtheria Toxoid [CS], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Clostridium Tetani Vaccine [EPC], Inactivated Corynebacterium Diphtheriae Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Poliovirus Vaccines [CS], Poliovirus Vaccines [CS], Poliovirus Vaccines [CS], Tetanus Toxoid [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080709</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>A single dose of KINRIX is indicated for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis as the fifth dose in the diphtheria, tetanus, and acellular pertussis (DTaP) vaccine series and the fourth dose in the inactivated poliovirus vaccine (IPV) series in children aged 4 through 6 years (prior to the seventh birthday) whose previous DTaP vaccine doses have been with INFANRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) and/or PEDIARIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine] for the first 3 doses and INFANRIX for the fourth dose.</IndicationAndUsage>
<Description>KINRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine) is a noninfectious, sterile, injectable suspension for intramuscular use. Each 0.5 mL dose is formulated to contain 25 Lf of diphtheria toxoid, 10 Lf of tetanus toxoid, 25 mcg of inactivated pertussis toxin (PT), 25 mcg of filamentous hemagglutinin (FHA), 8 mcg of pertactin (69 kiloDalton outer membrane protein), 40 D‑antigen Units (DU) of Type 1 poliovirus (Mahoney), 8 DU of Type 2 poliovirus (MEF‑1), and 32 DU of Type 3 poliovirus (Saukett). The diphtheria, tetanus, and pertussis components of KINRIX are the same as those in INFANRIX and PEDIARIX and the poliovirus component is the same as that in PEDIARIX. The diphtheria toxin is produced by growing Corynebacterium diphtheriae (C. diphtheriae) in Fenton medium containing a bovine extract. Tetanus toxin is produced by growing Clostridium tetani (C. tetani) in a modified Latham medium derived from bovine casein. The bovine materials used in these extracts are sourced from countries which the United States Department of Agriculture (USDA) has determined neither have nor are at risk of bovine spongiform encephalopathy (BSE). Both toxins are detoxified with formaldehyde, concentrated by ultrafiltration, and purified by precipitation, dialysis, and sterile filtration. The acellular pertussis antigens (PT, FHA, and pertactin) are isolated from Bordetella pertussis (B. pertussis) culture grown in modified Stainer-Scholte liquid medium. PT and FHA are isolated from the fermentation broth; pertactin is extracted from the cells by heat treatment and flocculation. The antigens are purified in successive chromatographic and precipitation steps. PT is detoxified using glutaraldehyde and formaldehyde. FHA and pertactin are treated with formaldehyde. Diphtheria and tetanus toxoids and pertussis antigens (inactivated PT, FHA, and pertactin) are individually adsorbed onto aluminum hydroxide. The inactivated poliovirus component of KINRIX is an enhanced potency component. Each of the 3 strains of poliovirus is individually grown in VERO cells, a continuous line of monkey kidney cells, cultivated on microcarriers. Calf serum and lactalbumin hydrolysate are used during VERO cell culture and/or virus culture. Calf serum is sourced from countries the USDA has determined neither have nor are at risk of BSE. After clarification, each viral suspension is purified by ultrafiltration, diafiltration, and successive chromatographic steps, and inactivated with formaldehyde. The 3 purified viral strains are then pooled to form a trivalent concentrate. Diphtheria and tetanus toxoid potency is determined by measuring the amount of neutralizing antitoxin in previously immunized guinea pigs. The potency of the acellular pertussis components (inactivated PT, FHA, and pertactin) is determined by enzyme-linked immunosorbent assay (ELISA) on sera from previously immunized mice. The potency of the inactivated poliovirus component is determined by using the D-antigen ELISA and by a poliovirus-neutralizing cell culture assay on sera from previously immunized rats. Each 0.5 mL dose contains aluminum hydroxide as adjuvant (formulated to contain 0.5 mg aluminum) and ≤4.4 mg of sodium chloride. The aluminum content is measured by assay. Each dose also contains ≤100 mcg of residual formaldehyde and ≤100 mcg of polysorbate 80 (Tween 80). Neomycin sulfate and polymyxin B sulfate are used in the poliovirus vaccine manufacturing process and may be present in the final vaccine at ≤0.05 ng neomycin and ≤0.01 ng polymyxin B per dose. The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex. KINRIX does not contain a preservative.</Description>
</NDC>
<NDC>
<NDCCode>59310-812-06</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (59310-812-06) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER</PackageDescription>
<NDC11Code>59310-0812-06</NDC11Code>
<ProductNDC>59310-812</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Airduo Respiclick</ProprietaryName>
<NonProprietaryName>Fluticasone Propionate And Salmeterol</NonProprietaryName>
<DosageFormName>POWDER, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20170420</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208799</ApplicationNumber>
<LabelerName>Teva Respiratory, LLC</LabelerName>
<SubstanceName>FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE</SubstanceName>
<StrengthNumber>113; 14</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170424</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AIRDUO® RESPICLICK® is indicated for the treatment of asthma in adult and pediatric patients aged 12 years and older. AIRDUO RESPICLICK should be used for patients not adequately controlled on a long term asthma control medication such as an inhaled corticosteroid or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long acting beta2-adrenergic agonist (LABA). Limitations of Use:. AIRDUO RESPICLICK is not indicated for the relief of acute bronchospasm.</IndicationAndUsage>
<Description>AIRDUO RESPICLICK 55 mcg/14 mcg, AIRDUO RESPICLICK 113 mcg/14 mcg and AIRDUO RESPICLICK 232 mcg/14 mcg are combinations of fluticasone propionate and salmeterol. Fluticasone Propionate. One active component of AIRDUO RESPICLICK is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11ß,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17ß-carbothioate, 17-propionate, and the following chemical structure. Fluticasone propionate is a white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. Salmeterol Xinafoate. The other active component of AIRDUO RESPICLICK is salmeterol xinafoate, a beta2–adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1‑hydroxy‑2‑naphthoic acid salt of salmeterol. It has the chemical name 4-hydroxy-α -[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-1,3-benzenedimethanol, 1-hydroxy-2-naphthalenecarboxylate and the following chemical structure. Salmeterol xinafoate is a white powder with a molecular weight of 603.8, and the empirical formula is C25H37NO4C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. AIRDUO RESPICLICK. AIRDUO RESPICLICK is a multidose dry powder inhaler (MDPI) for oral inhalation only. It contains fluticasone propionate, salmeterol xinafoate, and lactose monohydrate (which may contain milk proteins). The opening of the mouthpiece cover meters 5.5 mg of the formulation from the device reservoir, which contains 55 mcg, 113 mcg, or 232 mcg of fluticasone propionate, and 14 mcg of salmeterol base (equivalent to 20.3 mcg of salmeterol xinafoate). Patient inhalation through the mouthpiece causes the deagglomeration and aerosolization of the drug particles as the formulation moves through the cyclone component of the device. This is followed by dispersion into the airstream. Under standardized in vitro test conditions, the AIRDUO RESPICLICK inhaler delivers 49 mcg, 100 mcg, or 202 mcg of fluticasone propionate and 12.75 mcg of salmeterol base (equivalent to 18.5 mcg of salmeterol xinafoate), with lactose from the mouthpiece when tested at a flow rate of 85 L/min for 1.4 seconds. The amount of drug delivered to the lung will depend on patient factors such as inspiratory flow profiles. In adult subjects (N=50, aged 18 to 45 years) with asthma, mean peak inspiratory flow (PIF) through the AIRDUO RESPICLICK inhaler was 108.28 L/min (range: 70.37 to 129.24 L/min). In adolescent subjects (N=50, aged 12 to 17 years) with asthma, mean peak inspiratory flow (PIF) through the AIRDUO RESPICLICK inhaler was 106.72 L/min (range: 73.64 to 125.51 L/min).</Description>
</NDC>
<NDC>
<NDCCode>59310-812-08</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (59310-812-08) > 1 INHALER in 1 POUCH > 60 POWDER, METERED in 1 INHALER</PackageDescription>
<NDC11Code>59310-0812-08</NDC11Code>
<ProductNDC>59310-812</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Airduo Respiclick</ProprietaryName>
<NonProprietaryName>Fluticasone Propionate And Salmeterol</NonProprietaryName>
<DosageFormName>POWDER, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20170420</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208799</ApplicationNumber>
<LabelerName>Teva Respiratory, LLC</LabelerName>
<SubstanceName>FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE</SubstanceName>
<StrengthNumber>113; 14</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-02-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170420</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AIRDUO® RESPICLICK® is indicated for the treatment of asthma in adult and pediatric patients aged 12 years and older. AIRDUO RESPICLICK should be used for patients not adequately controlled on a long term asthma control medication such as an inhaled corticosteroid or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long acting beta2-adrenergic agonist (LABA). Limitations of Use:. AIRDUO RESPICLICK is not indicated for the relief of acute bronchospasm.</IndicationAndUsage>
<Description>AIRDUO RESPICLICK 55 mcg/14 mcg, AIRDUO RESPICLICK 113 mcg/14 mcg and AIRDUO RESPICLICK 232 mcg/14 mcg are combinations of fluticasone propionate and salmeterol. Fluticasone Propionate. One active component of AIRDUO RESPICLICK is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11ß,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17ß-carbothioate, 17-propionate, and the following chemical structure. Fluticasone propionate is a white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. Salmeterol Xinafoate. The other active component of AIRDUO RESPICLICK is salmeterol xinafoate, a beta2–adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1‑hydroxy‑2‑naphthoic acid salt of salmeterol. It has the chemical name 4-hydroxy-α -[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-1,3-benzenedimethanol, 1-hydroxy-2-naphthalenecarboxylate and the following chemical structure. Salmeterol xinafoate is a white powder with a molecular weight of 603.8, and the empirical formula is C25H37NO4C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. AIRDUO RESPICLICK. AIRDUO RESPICLICK is a multidose dry powder inhaler (MDPI) for oral inhalation only. It contains fluticasone propionate, salmeterol xinafoate, and lactose monohydrate (which may contain milk proteins). The opening of the mouthpiece cover meters 5.5 mg of the formulation from the device reservoir, which contains 55 mcg, 113 mcg, or 232 mcg of fluticasone propionate, and 14 mcg of salmeterol base (equivalent to 20.3 mcg of salmeterol xinafoate). Patient inhalation through the mouthpiece causes the deagglomeration and aerosolization of the drug particles as the formulation moves through the cyclone component of the device. This is followed by dispersion into the airstream. Under standardized in vitro test conditions, the AIRDUO RESPICLICK inhaler delivers 49 mcg, 100 mcg, or 202 mcg of fluticasone propionate and 12.75 mcg of salmeterol base (equivalent to 18.5 mcg of salmeterol xinafoate), with lactose from the mouthpiece when tested at a flow rate of 85 L/min for 1.4 seconds. The amount of drug delivered to the lung will depend on patient factors such as inspiratory flow profiles. In adult subjects (N=50, aged 18 to 45 years) with asthma, mean peak inspiratory flow (PIF) through the AIRDUO RESPICLICK inhaler was 108.28 L/min (range: 70.37 to 129.24 L/min). In adolescent subjects (N=50, aged 12 to 17 years) with asthma, mean peak inspiratory flow (PIF) through the AIRDUO RESPICLICK inhaler was 106.72 L/min (range: 73.64 to 125.51 L/min).</Description>
</NDC>
<NDC>
<NDCCode>59651-812-08</NDCCode>
<PackageDescription>120 CAPSULE in 1 BOTTLE (59651-812-08) </PackageDescription>
<NDC11Code>59651-0812-08</NDC11Code>
<ProductNDC>59651-812</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Icosapent Ethyl</ProprietaryName>
<NonProprietaryName>Icosapent Ethyl</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260624</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218949</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>ICOSAPENT ETHYL</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260624</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Icosapent ethyl capsules are indicated: : 1 as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. .</IndicationAndUsage>
<Description>Icosapent ethyl, a lipid-regulating agent, is supplied as a 1 gram amber colored, liquid-filled soft gelatin capsule for oral use. Each icosapent ethyl capsule contains 1 gram of icosapent ethyl (in a 1 gram capsule). Icosapent ethyl is an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA). The molecular formula of icosapent ethyl is C22H34O2 and the molecular weight is 330.51. The chemical name for icosapent ethyl is ethyl allcis-5,8,11,14,17-icosapentaenoate with the following chemical structure:. Icosapent ethyl capsules also contain the following inactive ingredients: Gelatin, glycerin, maltitol solution, non – crystallizing sorbitol solution, purified water and vitamin-E.</Description>
</NDC>
<NDC>
<NDCCode>60267-812-00</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (60267-812-00) * 10 mL in 1 VIAL, SINGLE-USE (60267-311-10) * 50 mL in 1 VIAL, SINGLE-DOSE (60267-705-50) </PackageDescription>
<NDC11Code>60267-0812-00</NDC11Code>
<ProductNDC>60267-812</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nithiodote</ProprietaryName>
<NonProprietaryName>Sodium Nitrite And Sodium Thiosulfate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20110114</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA201444</ApplicationNumber>
<LabelerName>Hope Pharmaceuticals</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-10-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NITHIODOTE is indicated for the treatment of acute cyanide poisoning that is judged to be serious or life-threatening. When the diagnosis of cyanide poisoning is uncertain, carefully weigh the potentially life-threatening risks associated with NITHIODOTE against the potential benefits, especially if the patient is not in extremis.</IndicationAndUsage>
<Description>Sodium nitrite, one of the active ingredients in NITHIODOTE has the chemical name nitrous acid sodium salt. The chemical formula is NaNO2 and the molecular weight is 69.0. Sodium thiosulfate, the second active ingredient in NITHIODOTE has the chemical name thiosulfuric acid, disodium salt, pentahydrate. The chemical formula is Na2S2O3∙ 5H2O and the molecular weight is 248.17. The structural formulae are. Structure of Sodium Nitrite. Structure of Sodium Thiosulfate Pentahydrate. NITHIODOTE is a cyanide antidote which contains one 10 mL glass vial of a 3% solution of sodium nitrite injection and one 50 mL glass vial containing a 25% solution of sodium thiosulfate injection. Sodium nitrite injection is a sterile aqueous solution and is intended for intravenous injection. Each vial contains 300 mg of sodium nitrite in 10 mL solution (30 mg/mL). Sodium nitrite injection is a clear solution with a pH between 7.0 and 9.0. Sodium thiosulfate injection is a sterile aqueous solution and is intended for intravenous injection. Each vial contains 12.5 grams of sodium thiosulfate in 50 mL solution (250 mg/mL). Each mL also contains 2.8 mg boric acid and 4.4 mg of potassium chloride. The pH of the solution is adjusted with boric acid and/or sodium hydroxide. Sodium thiosulfate injection is a clear solution with a pH between 7.5 and 9.0.</Description>
</NDC>
<NDC>
<NDCCode>60687-812-01</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (60687-812-01) / 1 TABLET in 1 BLISTER PACK (60687-812-11) </PackageDescription>
<NDC11Code>60687-0812-01</NDC11Code>
<ProductNDC>60687-812</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buspirone Hydrochloride</ProprietaryName>
<NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240307</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078888</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240307</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets have been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III 1 as follows:. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 Motor tension Shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle. , 2 Autonomic hyperactivity Sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate. , 3 Apprehensive expectation Anxiety, worry, fear, rumination, and anticipation of misfortune to self or others. , 4 Vigilance and scanning Hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge," irritability, impatience. .</IndicationAndUsage>
<Description>Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride, USP is a white crystalline powder. It is very soluble in water; freely soluble in methanol and in methylene chloride; sparingly soluble in ethanol and in acetonitrile; very slightly soluble in ethyl acetate and practically insoluble in hexanes. Its molecular weight is 422. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The molecular formula C 21H 31N 5O 2HCl is represented by the following structural formula:. Each buspirone hydrochloride tablet intended for oral administration contains 5 mg or 7.5 mg or 10 mg or 15 mg or 30 mg buspirone hydrochloride (equivalent to 4.6 mg, 6.85 mg, 9.1 mg, 13.7 mg, and 27.4 mg of buspirone free base, respectively). In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg and 30 mg tablets are scored so they can be either bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one half of a tablet), or 5 mg (one third of a tablet). A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two thirds of a tablet), 15 mg (one half of a tablet), or 10 mg (one third of a tablet).</Description>
</NDC>
<NDC>
<NDCCode>61047-812-73</NDCCode>
<PackageDescription>236 mL in 1 TUBE (61047-812-73)</PackageDescription>
<NDC11Code>61047-0812-73</NDC11Code>
<ProductNDC>61047-812</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Banana Boat Ultra Defense Sheer Protect</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100319</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>KIK Custom Products</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>2.36; 23.6; 11.8; 1.88; 9.44</StrengthNumber>
<StrengthUnit>mL/236mL; mL/236mL; mL/236mL; mL/236mL; mL/236mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63187-812-07</NDCCode>
<PackageDescription>7 TABLET, FILM COATED in 1 BOTTLE (63187-812-07) </PackageDescription>
<NDC11Code>63187-0812-07</NDC11Code>
<ProductNDC>63187-812</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160722</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090478</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-04-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210514</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyclobenzaprine HCl tablets USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine HCl should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine HCl has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
<Description>Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C20H21NHCl and a molecular weight of 311.9. It has a melting point of 217˚C, and a pKa of 8.47 at 25˚C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl, USP is designated chemically as 3-(5H –dibenzo[a,d]cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine HCl USP, 5 mg is supplied as a 5 mg tablet for oral administration. Cyclobenzaprine HCl USP, 10 mg is supplied as a 10 mg tablet for oral administration. Cyclobenzaprine HCl tablets USP, 5 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry beige (hypromellose 6cP, titanium dioxide, PEG 400, iron oxide yellow and iron oxide red). Cyclobenzaprine HCl tablets USP, 10 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry yellow (hypromellose 3cp, hypromellose 6cp, titanium dioxide, PEG 400, iron oxide yellow and polysorbate 80).</Description>
</NDC>
<NDC>
<NDCCode>63187-812-10</NDCCode>
<PackageDescription>10 TABLET, FILM COATED in 1 BOTTLE (63187-812-10) </PackageDescription>
<NDC11Code>63187-0812-10</NDC11Code>
<ProductNDC>63187-812</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160722</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090478</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-04-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyclobenzaprine HCl tablets USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine HCl should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine HCl has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
<Description>Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C20H21NHCl and a molecular weight of 311.9. It has a melting point of 217˚C, and a pKa of 8.47 at 25˚C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl, USP is designated chemically as 3-(5H –dibenzo[a,d]cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine HCl USP, 5 mg is supplied as a 5 mg tablet for oral administration. Cyclobenzaprine HCl USP, 10 mg is supplied as a 10 mg tablet for oral administration. Cyclobenzaprine HCl tablets USP, 5 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry beige (hypromellose 6cP, titanium dioxide, PEG 400, iron oxide yellow and iron oxide red). Cyclobenzaprine HCl tablets USP, 10 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry yellow (hypromellose 3cp, hypromellose 6cp, titanium dioxide, PEG 400, iron oxide yellow and polysorbate 80).</Description>
</NDC>
<NDC>
<NDCCode>63187-812-12</NDCCode>
<PackageDescription>12 TABLET, FILM COATED in 1 BOTTLE (63187-812-12) </PackageDescription>
<NDC11Code>63187-0812-12</NDC11Code>
<ProductNDC>63187-812</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160722</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090478</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-04-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180402</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyclobenzaprine HCl tablets USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine HCl should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine HCl has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
<Description>Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C20H21NHCl and a molecular weight of 311.9. It has a melting point of 217˚C, and a pKa of 8.47 at 25˚C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl, USP is designated chemically as 3-(5H –dibenzo[a,d]cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine HCl USP, 5 mg is supplied as a 5 mg tablet for oral administration. Cyclobenzaprine HCl USP, 10 mg is supplied as a 10 mg tablet for oral administration. Cyclobenzaprine HCl tablets USP, 5 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry beige (hypromellose 6cP, titanium dioxide, PEG 400, iron oxide yellow and iron oxide red). Cyclobenzaprine HCl tablets USP, 10 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry yellow (hypromellose 3cp, hypromellose 6cp, titanium dioxide, PEG 400, iron oxide yellow and polysorbate 80).</Description>
</NDC>
<NDC>
<NDCCode>63187-812-15</NDCCode>
<PackageDescription>15 TABLET, FILM COATED in 1 BOTTLE (63187-812-15) </PackageDescription>
<NDC11Code>63187-0812-15</NDC11Code>
<ProductNDC>63187-812</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160722</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090478</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-04-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyclobenzaprine HCl tablets USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine HCl should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine HCl has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
<Description>Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C20H21NHCl and a molecular weight of 311.9. It has a melting point of 217˚C, and a pKa of 8.47 at 25˚C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl, USP is designated chemically as 3-(5H –dibenzo[a,d]cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine HCl USP, 5 mg is supplied as a 5 mg tablet for oral administration. Cyclobenzaprine HCl USP, 10 mg is supplied as a 10 mg tablet for oral administration. Cyclobenzaprine HCl tablets USP, 5 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry beige (hypromellose 6cP, titanium dioxide, PEG 400, iron oxide yellow and iron oxide red). Cyclobenzaprine HCl tablets USP, 10 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry yellow (hypromellose 3cp, hypromellose 6cp, titanium dioxide, PEG 400, iron oxide yellow and polysorbate 80).</Description>
</NDC>
<NDC>
<NDCCode>63187-812-20</NDCCode>
<PackageDescription>20 TABLET, FILM COATED in 1 BOTTLE (63187-812-20) </PackageDescription>
<NDC11Code>63187-0812-20</NDC11Code>
<ProductNDC>63187-812</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160722</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090478</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-04-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyclobenzaprine HCl tablets USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine HCl should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine HCl has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
<Description>Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C20H21NHCl and a molecular weight of 311.9. It has a melting point of 217˚C, and a pKa of 8.47 at 25˚C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl, USP is designated chemically as 3-(5H –dibenzo[a,d]cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine HCl USP, 5 mg is supplied as a 5 mg tablet for oral administration. Cyclobenzaprine HCl USP, 10 mg is supplied as a 10 mg tablet for oral administration. Cyclobenzaprine HCl tablets USP, 5 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry beige (hypromellose 6cP, titanium dioxide, PEG 400, iron oxide yellow and iron oxide red). Cyclobenzaprine HCl tablets USP, 10 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry yellow (hypromellose 3cp, hypromellose 6cp, titanium dioxide, PEG 400, iron oxide yellow and polysorbate 80).</Description>
</NDC>
<NDC>
<NDCCode>63187-812-21</NDCCode>
<PackageDescription>21 TABLET, FILM COATED in 1 BOTTLE (63187-812-21) </PackageDescription>
<NDC11Code>63187-0812-21</NDC11Code>
<ProductNDC>63187-812</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160722</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090478</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-04-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyclobenzaprine HCl tablets USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine HCl should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine HCl has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
<Description>Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C20H21NHCl and a molecular weight of 311.9. It has a melting point of 217˚C, and a pKa of 8.47 at 25˚C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl, USP is designated chemically as 3-(5H –dibenzo[a,d]cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine HCl USP, 5 mg is supplied as a 5 mg tablet for oral administration. Cyclobenzaprine HCl USP, 10 mg is supplied as a 10 mg tablet for oral administration. Cyclobenzaprine HCl tablets USP, 5 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry beige (hypromellose 6cP, titanium dioxide, PEG 400, iron oxide yellow and iron oxide red). Cyclobenzaprine HCl tablets USP, 10 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry yellow (hypromellose 3cp, hypromellose 6cp, titanium dioxide, PEG 400, iron oxide yellow and polysorbate 80).</Description>
</NDC>
<NDC>
<NDCCode>63187-812-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (63187-812-30) </PackageDescription>
<NDC11Code>63187-0812-30</NDC11Code>
<ProductNDC>63187-812</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160722</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090478</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-04-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyclobenzaprine HCl tablets USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine HCl should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine HCl has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
<Description>Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C20H21NHCl and a molecular weight of 311.9. It has a melting point of 217˚C, and a pKa of 8.47 at 25˚C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl, USP is designated chemically as 3-(5H –dibenzo[a,d]cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine HCl USP, 5 mg is supplied as a 5 mg tablet for oral administration. Cyclobenzaprine HCl USP, 10 mg is supplied as a 10 mg tablet for oral administration. Cyclobenzaprine HCl tablets USP, 5 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry beige (hypromellose 6cP, titanium dioxide, PEG 400, iron oxide yellow and iron oxide red). Cyclobenzaprine HCl tablets USP, 10 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry yellow (hypromellose 3cp, hypromellose 6cp, titanium dioxide, PEG 400, iron oxide yellow and polysorbate 80).</Description>
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