{
"NDC": [
{
"NDCCode": "17856-4069-4",
"PackageDescription": "4.8 mL in 1 CUP (17856-4069-4) ",
"NDC11Code": "17856-4069-04",
"ProductNDC": "17856-4069",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenytoin",
"NonProprietaryName": "Phenytoin",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20040408",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040521",
"LabelerName": "ATLANTIC BIOLOGICALS CORP.",
"SubstanceName": "PHENYTOIN",
"StrengthNumber": "125",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-09-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210125",
"SamplePackage": "N"
},
{
"NDCCode": "17856-4069-1",
"PackageDescription": "125 mL in 1 CUP (17856-4069-1)",
"NDC11Code": "17856-4069-01",
"ProductNDC": "17856-4069",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenytoin",
"NonProprietaryName": "Phenytoin",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20040408",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040521",
"LabelerName": "Atlantic Biologicals Corps",
"SubstanceName": "PHENYTOIN",
"StrengthNumber": "125",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0498-4069-01",
"PackageDescription": "1 KIT in 1 KIT (0498-4069-01) * .4 mL in 1 POUCH * .9 g in 1 PACKET (0498-0730-01) * .9 g in 1 PACKET * 1.4 mL in 1 PACKET * 2 TABLET in 1 PACKET (0498-2001-01) * 30 mL in 1 BOTTLE (0498-0100-01) ",
"NDC11Code": "00498-4069-01",
"ProductNDC": "0498-4069",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "4069 First Aid Kit",
"NonProprietaryName": "4069 First Aid Kit",
"DosageFormName": "KIT",
"RouteName": "OPHTHALMIC; ORAL; TOPICAL",
"StartMarketingDate": "20181018",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Honeywell Safety Products USA, INC",
"Status": "Deprecated",
"LastUpdate": "2019-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20181018",
"SamplePackage": "N"
},
{
"NDCCode": "37662-4069-4",
"PackageDescription": "10000 PELLET in 1 BOTTLE, GLASS (37662-4069-4) ",
"NDC11Code": "37662-4069-04",
"ProductNDC": "37662-4069",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Strontium Nitricum",
"NonProprietaryName": "Strontium Nitricum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231002",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "STRONTIUM NITRATE",
"StrengthNumber": "1",
"StrengthUnit": "[hp_M]/1",
"Status": "Active",
"LastUpdate": "2023-10-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231002",
"SamplePackage": "N"
},
{
"NDCCode": "0093-4069-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0093-4069-01) ",
"NDC11Code": "00093-4069-01",
"ProductNDC": "0093-4069",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prazosin Hydrochloride",
"NonProprietaryName": "Prazosin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20070118",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071745",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "PRAZOSIN HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20070222",
"SamplePackage": "N",
"IndicationAndUsage": "Prazosin hydrochloride capsules USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal 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, including this drug. Control of high blood pressure 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 blood pressure 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 blood pressure 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 blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure 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 blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Prazosin hydrochloride capsules USP can be used alone or in combination with other antihypertensive drugs such as diuretics or beta-adrenergic blocking agents.",
"Description": "Prazosin hydrochloride, USP a quinazoline derivative, is the first of a new chemical class of antihypertensives. It is the hydrochloride salt of 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is. C19H21N5O4HCl M.W. 419.87. It is a white, crystalline substance, slightly soluble in water and isotonic saline. Each capsule for oral administration, contains prazosin hydrochloride, USP equivalent to 1 mg, 2 mg or 5 mg of prazosin. Inactive ingredients include: anhydrous lactose, magnesium stearate, and pregelatinized starch. Additional inactive ingredients for the gelatin capsule include: 1 mg (Ivory): D&C Yellow No. 10 and titanium dioxide; 2 mg (Pink): FD&C Blue No. 1, FD&C Red No. 40, D&C Red No. 28, and titanium dioxide; 5 mg (Light Blue): FD&C Blue No. 1 and titanium dioxide."
},
{
"NDCCode": "0093-4069-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (0093-4069-05) ",
"NDC11Code": "00093-4069-05",
"ProductNDC": "0093-4069",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prazosin Hydrochloride",
"NonProprietaryName": "Prazosin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20070118",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071745",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "PRAZOSIN HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20070118",
"SamplePackage": "N",
"IndicationAndUsage": "Prazosin hydrochloride capsules USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal 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, including this drug. Control of high blood pressure 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 blood pressure 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 blood pressure 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 blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure 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 blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Prazosin hydrochloride capsules USP can be used alone or in combination with other antihypertensive drugs such as diuretics or beta-adrenergic blocking agents.",
"Description": "Prazosin hydrochloride, USP a quinazoline derivative, is the first of a new chemical class of antihypertensives. It is the hydrochloride salt of 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is. C19H21N5O4HCl M.W. 419.87. It is a white, crystalline substance, slightly soluble in water and isotonic saline. Each capsule for oral administration, contains prazosin hydrochloride, USP equivalent to 1 mg, 2 mg or 5 mg of prazosin. Inactive ingredients include: anhydrous lactose, magnesium stearate, and pregelatinized starch. Additional inactive ingredients for the gelatin capsule include: 1 mg (Ivory): D&C Yellow No. 10 and titanium dioxide; 2 mg (Pink): FD&C Blue No. 1, FD&C Red No. 40, D&C Red No. 28, and titanium dioxide; 5 mg (Light Blue): FD&C Blue No. 1 and titanium dioxide."
},
{
"NDCCode": "0093-4069-52",
"PackageDescription": "250 CAPSULE in 1 BOTTLE (0093-4069-52) ",
"NDC11Code": "00093-4069-52",
"ProductNDC": "0093-4069",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prazosin Hydrochloride",
"NonProprietaryName": "Prazosin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20070118",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071745",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "PRAZOSIN HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20070222",
"SamplePackage": "N",
"IndicationAndUsage": "Prazosin hydrochloride capsules USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal 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, including this drug. Control of high blood pressure 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 blood pressure 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 blood pressure 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 blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure 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 blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Prazosin hydrochloride capsules USP can be used alone or in combination with other antihypertensive drugs such as diuretics or beta-adrenergic blocking agents.",
"Description": "Prazosin hydrochloride, USP a quinazoline derivative, is the first of a new chemical class of antihypertensives. It is the hydrochloride salt of 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is. C19H21N5O4HCl M.W. 419.87. It is a white, crystalline substance, slightly soluble in water and isotonic saline. Each capsule for oral administration, contains prazosin hydrochloride, USP equivalent to 1 mg, 2 mg or 5 mg of prazosin. Inactive ingredients include: anhydrous lactose, magnesium stearate, and pregelatinized starch. Additional inactive ingredients for the gelatin capsule include: 1 mg (Ivory): D&C Yellow No. 10 and titanium dioxide; 2 mg (Pink): FD&C Blue No. 1, FD&C Red No. 40, D&C Red No. 28, and titanium dioxide; 5 mg (Light Blue): FD&C Blue No. 1 and titanium dioxide."
},
{
"NDCCode": "50090-4069-0",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50090-4069-0) ",
"NDC11Code": "50090-4069-00",
"ProductNDC": "50090-4069",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desvenlafaxine Succinate",
"NonProprietaryName": "Desvenlafaxine Succinate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170301",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021992",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "DESVENLAFAXINE SUCCINATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190118",
"SamplePackage": "N",
"IndicationAndUsage": "Desvenlafaxine is indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies (14)].",
"Description": "Desvenlafaxine is an extended-release tablet for oral administration that contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the empirical formula of C16H25NO2 (free base) and C16H25NO2∙C4H6O4∙H2O (succinate monohydrate). Desvenlafaxine succinate monohydrate has a molecular weight of 399.48. The structural formula is shown below. Desvenlafaxine succinate is a white to off-white powder that is soluble in water. The solubility of desvenlafaxine succinate is pH dependent. Its octanol:aqueous system (at pH 7.0) partition coefficient is 0.21. Desvenlafaxine is formulated as an extended-release tablet for once-a-day oral administration. Each tablet contains 38 mg, 76 mg or 152 mg of desvenlafaxine succinate equivalent to 25 mg, 50 mg or 100 mg of desvenlafaxine, respectively. Inactive ingredients for the 25 mg tablet consist of hypromellose, microcrystalline cellulose, talc, magnesium stearate, a film coating which consists of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, and iron oxides. Inactive ingredients for the 50 mg tablet consist of hypromellose, microcrystalline cellulose, talc, magnesium stearate and film coating, which consists of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, and iron oxides. Inactive ingredients for the 100 mg tablet consist of hypromellose, microcrystalline cellulose, talc, magnesium stearate and film coating, which consists of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, iron oxide and FD&C yellow #6."
},
{
"NDCCode": "51672-4069-1",
"PackageDescription": "237 mL in 1 BOTTLE (51672-4069-1) ",
"NDC11Code": "51672-4069-01",
"ProductNDC": "51672-4069",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenytoin",
"NonProprietaryName": "Phenytoin",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20040408",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040521",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "PHENYTOIN",
"StrengthNumber": "125",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20040408",
"EndMarketingDatePackage": "20260731",
"SamplePackage": "N",
"IndicationAndUsage": "Phenytoin oral suspension is indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures.",
"Description": "Phenytoin is related to the barbiturates in chemical structure, but has a five-membered ring. The chemical name is 5,5-diphenyl-2,4 imidazolidinedione, having the following structural formula. Each 5 mL of the oral suspension contains 125 mg of phenytoin, USP; carboxymethylcellulose sodium, citric acid anhydrous, FD&C yellow no. 6, magnesium aluminum silicate, orange flavor spray dry natural and artificial, polysorbate 60, purified water, sodium benzoate, sucrose and vanilla flavored powder artificial."
},
{
"NDCCode": "51672-4069-2",
"PackageDescription": "1 BOTTLE in 1 CARTON (51672-4069-2) / 237 mL in 1 BOTTLE",
"NDC11Code": "51672-4069-02",
"ProductNDC": "51672-4069",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenytoin",
"NonProprietaryName": "Phenytoin",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20040408",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040521",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "PHENYTOIN",
"StrengthNumber": "125",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-08-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250723",
"SamplePackage": "N",
"IndicationAndUsage": "Phenytoin oral suspension is indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures.",
"Description": "Phenytoin is related to the barbiturates in chemical structure, but has a five-membered ring. The chemical name is 5,5-diphenyl-2,4 imidazolidinedione, having the following structural formula. Each 5 mL of the oral suspension contains 125 mg of phenytoin, USP; carboxymethylcellulose sodium, citric acid anhydrous, FD&C yellow no. 6, magnesium aluminum silicate, orange flavor spray dry natural and artificial, polysorbate 60, purified water, sodium benzoate, sucrose and vanilla flavored powder artificial."
},
{
"NDCCode": "17856-0010-4",
"PackageDescription": "100 DOSE PACK in 1 CONTAINER (17856-0010-4) > 1 TABLET, COATED in 1 DOSE PACK",
"NDC11Code": "17856-0010-04",
"ProductNDC": "17856-0010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dialyvite",
"NonProprietaryName": "Ascorbic Acid, Thiamine, Riboflavin, Niacinamide, Pyridoxine, Folic Acid, Cobalamin, Biotin, Pantothenic Acid",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19880801",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Atlantic Biologicals Corps",
"SubstanceName": "ASCORBIC ACID; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; COBALAMIN; BIOTIN; CALCIUM PANTOTHENATE",
"StrengthNumber": "100; 1.5; 1.7; 20; 10; 1; 6; 300; 10",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1",
"Pharm_Classes": "Vitamin C [EPC],Ascorbic Acid [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Dialyvite is a prescription folic acid supplement with additional nutrients indicated for use in improving the nutritional status of renal dialysis patients.",
"Description": "Dialyvite is a prescription folic acid supplement with additional nutrients for kidney dialysis patients. Dialyvite is a small, round, light pink, clear-coated tablet, with debossed \"H\" on one side. Each tablet contains. Folic Acid.....1 mg. Vitamin C (Ascorbic Acid).....100 mg. Thiamine (Thiamine Mononitrate).....1.5 mg. Riboflavin.....1.7 mg. Niacinamide.....20 mg. Vitamin B6 (Pyridoxine HCl).....10 mg. Vitamin B12 (Methylcobalamin).....6 mcg. Biotin.....300 mcg. Pantothenic Acid (Calcium Pantothenate).....10 mg. Inactive ingredients. Microcrystalline Cellulose, Croscarmellose Sodium, Mono- and Diglycerides, Starch, Hypromellose, Polyethylene Glycol, Calcium Stearate, Carmine (color)."
},
{
"NDCCode": "17856-0016-4",
"PackageDescription": "7.5 mL in 1 SYRINGE (17856-0016-4) ",
"NDC11Code": "17856-0016-04",
"ProductNDC": "17856-0016",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenobarbital",
"NonProprietaryName": "Phenobarbital",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20180303",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "ATLANTIC BIOLOGICALS CORP",
"SubstanceName": "PHENOBARBITAL",
"StrengthNumber": "20",
"StrengthUnit": "mg/5mL",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180316",
"SamplePackage": "N",
"IndicationAndUsage": "A. Sedative. B. Anticonvulsant- For the treatment of generalized and partial seizures.",
"Description": "The barbiturates are nonselective central nervous system (CNS) depressants that are primarily used as sedative-hypnotics. In subhypnotic doses, they are also used as anticonvulsants. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act. Phenobarbital is a barbituric acid derivative and occurs as white, odorless, small crystals or crystalline powder that is very slightly soluble in water; soluble in alcohol, in either, and in solutions of fixed alkali hydroxides and carbonates; sparingly soluble in chloroform. Phenobarbital is 5-ethyl-5-phenylbarbituric acid and has the empirical formula C12H12N2O3. Its molecular weight is 232.24. It has the following structural formula. Phenobarbital is a substituted pyrimidine derivative in which the basic structure is barbituric acid, a substance that has no CNS activity. CNS activity is obtained by substituting alkyl, alkenyl, or aryl groups on the pyrimidine ring. Each 5 mL (teaspoon) contains 20 mg Phenobarbital and Alcohol 15%. The oral solution also contains FD&C Red #40, orange flavor, glycerin, sucrose, and water."
},
{
"NDCCode": "17856-0023-4",
"PackageDescription": "60 SYRINGE in 1 BOX, UNIT-DOSE (17856-0023-4) / 1 mL in 1 SYRINGE",
"NDC11Code": "17856-0023-04",
"ProductNDC": "17856-0023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20180601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209897",
"LabelerName": "ALTANTIC BIOLOGICALS CORP",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20230309",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone Hydrochloride Oral Solution is an opioid agonist indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. (1). Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/mL) is indicated for the relief of pain in opioid-tolerant adults. Limitations of Use (1) Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Oxycodone Hydrochloride 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": "Oxycodone Hydrochloride Oral Solution is an agonist, available as a yellow solution 100 mg/5 mL (20 mg/mL) for oral administration. The chemical name is (5R,9R,13S,14S)-4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 351.82. Its molecular formula is C18H21NO4.HCl, and it has the following chemical structure. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine.It is soluble in water and slightly soluble in alcohol. The inactive ingredients in Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/ mL): include: citric acid anhydrous, D&C Yellow #10, mixed berry flavor, purified water, sodium citrate dihydrate, sodium benzoate, saccharin sodium, sorbitol."
},
{
"NDCCode": "17856-0025-4",
"PackageDescription": "48 SYRINGE in 1 BOX, UNIT-DOSE (17856-0025-4) / 5 mL in 1 SYRINGE (17856-0025-8) ",
"NDC11Code": "17856-0025-04",
"ProductNDC": "17856-0025",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Max Relief Junior",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20230514",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M",
"LabelerName": "ATLANTIC BIOLOGICALS CORP.",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "160",
"StrengthUnit": "mg/5mL",
"Status": "Active",
"LastUpdate": "2024-03-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240228",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 temporarily , 2 reduces fever, 3 relieves minor aches and pains due to:, 4 the common cold, 5 flu, 6 headache, 7 sore throat, 8 toothache."
},
{
"NDCCode": "17856-0045-4",
"PackageDescription": "120 SYRINGE in 1 BOX, UNIT-DOSE (17856-0045-4) / 2.5 mL in 1 SYRINGE (17856-0045-8) ",
"NDC11Code": "17856-0045-04",
"ProductNDC": "17856-0045",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Max Relief Junior",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20230514",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M",
"LabelerName": "ATLANTIC BIOLOGICALS CORP.",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "160",
"StrengthUnit": "mg/5mL",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240228",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 temporarily , 2 reduces fever, 3 relieves minor aches and pains due to:, 4 the common cold, 5 flu, 6 headache, 7 sore throat, 8 toothache."
},
{
"NDCCode": "17856-0048-3",
"PackageDescription": "50 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0048-3) / 30 mL in 1 CUP, UNIT-DOSE (17856-0048-4) ",
"NDC11Code": "17856-0048-03",
"ProductNDC": "17856-0048",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"NonProprietaryName": "Potassium Chloride Oral",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20231005",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211648",
"LabelerName": "ATLANTIC BIOLOGICALS CORP.",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "1.5",
"StrengthUnit": "g/15mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240711",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium chloride oral solution is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient.",
"Description": "Potassium chloride, USP is a white crystalline powder or colorless crystals. It is freely soluble in water and practically insoluble in ethanol. Chemically, potassium chloride, USP is K-Cl with a molecular mass of 74.55. Oral Solution 10%: Each 15 mL of solution contains 1.5 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow No. 6, glycerin, methylparaben, natural & artificial orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose. Oral Solution 20%: Each 15 mL of solution contains 3.0 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow No. 6,glycerin, methylparaben, natural & artificial orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose."
},
{
"NDCCode": "17856-0060-4",
"PackageDescription": "50 CUP in 1 BOX (17856-0060-4) / 20 mL in 1 CUP (17856-0060-2) ",
"NDC11Code": "17856-0060-04",
"ProductNDC": "17856-0060",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Megestrol Acetate",
"NonProprietaryName": "Megestrol Acetate",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20220321",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075671",
"LabelerName": "ATLANTIC BIOLOGICALS CORP.",
"SubstanceName": "MEGESTROL ACETATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240509",
"SamplePackage": "N",
"IndicationAndUsage": "Megestrol acetate oral suspension, USP is indicated for the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS).",
"Description": "Megestrol Acetate Oral Suspension, USP contains megestrol acetate, a synthetic derivative of the steroid hormone, progesterone. Megestrol acetate is a white, crystalline solid chemically designated as 17-Hydroxy-6-methylpregna-4,6-diene-3,20-dione acetate. Solubility at 37°C in water is 2 mcg per mL, solubility in plasma is 24 mcg per mL. Its molecular weight is 384.52. The chemical formula is C 24H 32O 4and the structural formula is represented as follows:. Megestrol acetate oral suspension is supplied as an oral suspension containing 40 mg of micronized megestrol acetate per mL. Megestrol acetate oral suspension contains the following inactive ingredients: alcohol (max 0.06% v/v from flavor), artificial lime flavor, citric acid monohydrate, docusate sodium, glycerin, natural and artificial lemon flavor, purified water, sodium benzoate, sodium citrate dihydrate, sucrose and xanthan gum. Megestrol acetate oral suspension, 40 mg/mL complies with USP Dissolution Test 2."
},
{
"NDCCode": "17856-0063-4",
"PackageDescription": "48 SYRINGE in 1 BOX, UNIT-DOSE (17856-0063-4) / 4 mL in 1 SYRINGE",
"NDC11Code": "17856-0063-04",
"ProductNDC": "17856-0063",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20090729",
"EndMarketingDate": "20240531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076904",
"LabelerName": "ATLANTIC BIOLOGICALS CORP.",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20240513",
"EndMarketingDatePackage": "20240531",
"SamplePackage": "N"
},
{
"NDCCode": "17856-0067-3",
"PackageDescription": "4 mL in 1 CUP (17856-0067-3)",
"NDC11Code": "17856-0067-03",
"ProductNDC": "17856-0067",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenytoin",
"NonProprietaryName": "Phenytoin",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20020624",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040420",
"LabelerName": "Atlantic Biologicals Corps",
"SubstanceName": "PHENYTOIN",
"StrengthNumber": "125",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Phenytoin Oral Suspension is indicated for the control of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures. Phenytoin serum level determinations may be necessary for optimal dosage adjustments (see and sections). DOSAGE AND ADMINISTRATIONCLINICAL PHARMACOLOGY.",
"Description": "Phenytoin is related to the barbiturates in chemical structure, but has a five-membered ring. The chemical name is 5,5-Diphenylhydantoin, having the following structural formula. Each 5 mL (teaspoonful) of suspension contains 125 mg of phenytoin, USP with an alcohol content of 0.35 percent. Also contains carboxymethylcellulose sodium, citric acid anhydrous, dehydrated alcohol, FD&C Yellow No. 6, glycerin, liquid sugar, magnesium aluminum silicate, orange flavor, polysorbate 40, purified water, sodium benzoate, sodium citrate dihydrate and vanillin. It may contain 10% citric acid solution or 10% sodium citrate solution to adjust pH. The pH range is between 3.6 and 5.2."
},
{
"NDCCode": "17856-0079-4",
"PackageDescription": "12 mL in 1 CUP (17856-0079-4) ",
"NDC11Code": "17856-0079-04",
"ProductNDC": "17856-0079",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetaminophen And Codeine Phosphate",
"NonProprietaryName": "Acetaminophen And Codeine Phosphate",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "19960426",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040119",
"LabelerName": "ATLANTIC BIOLOGICALS COPR.",
"SubstanceName": "ACETAMINOPHEN; CODEINE PHOSPHATE",
"StrengthNumber": "120; 12",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CV",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210112",
"SamplePackage": "N",
"IndicationAndUsage": "Acetaminophen and codeine phosphate oral solution is indicated for the relief of mild to moderate pain.",
"Description": "Acetaminophen and codeine phosphate oral solution is pharmacologically classified as an analgesic. Acetaminophen, 4’-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, nonsalicylate analgesic and antipyretic. It has the following structural formula. Codeine phosphate, 7,8-didehydro- 4, 5α-epoxy-3- methoxy-17-methylmorphinan- 6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula. Each 5 mL, for oral administration, contains. Acetaminophen 120 mg. Codeine Phosphate 12 mg. (Warning: May be habit forming). Alcohol 7%. In addition the following inactive ingredients are present: artificial cherry flavor, citric acid, FD&C Yellow No. 6, propylene glycol, purified water, saccharin sodium, sodium benzoate, and sucrose."
},
{
"NDCCode": "17856-0083-1",
"PackageDescription": "72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0083-1) / 5 mL in 1 CUP, UNIT-DOSE (17856-0083-4) ",
"NDC11Code": "17856-0083-01",
"ProductNDC": "17856-0083",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20020903",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074738",
"LabelerName": "ATLANTIC BIOLOGICALS CORP.",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "200",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
"Status": "Active",
"LastUpdate": "2026-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240416",
"SamplePackage": "N",
"IndicationAndUsage": "Herpes Zoster Infections:Acyclovir is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes:Acyclovir is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox:Acyclovir is indicated for the treatment of chickenpox (varicella).",
"Description": "Acyclovir is a synthetic nucleoside analogue active against herpes viruses. Acyclovir suspension is formulated for oral administration. Each teaspoonful (5 mL) of acyclovir oral suspension USP contains 200 mg of acyclovir and the inactive ingredients carboxymethylcellulose sodium, flavor, glycerin, methylparaben (0.1%), microcrystalline cellulose, propylparaben (0.02%), purified water and sorbitol. Acyclovir is a white, crystalline powder with the molecular formula C 8H 11N 5O 3, and a molecular weight of 225.20. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 9-[(2-Hydroxyethoxy)methyl]guanine; it has the following structural formula. VIROLOGY. Mechanism of Antiviral Action. Acyclovir is a synthetic purine nucleoside analogue with in vitroand in vivoinhibitory activity against herpes simplex virus types 1 (HSV-1), 2 (HSV-2), and varicella-zoster virus (VZV). The inhibitory activity of acyclovir is highly selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV and VZV. This viral enzyme converts acyclovir into acyclovir monophosphate, a nucleotide analogue. The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by a number of cellular enzymes. In vitro, acyclovir triphosphate stops replication of herpes viral DNA. This is accomplished in three ways: 1) competitive inhibition of viral DNA polymerase, 2) incorporation into and termination of the growing viral DNA chain, and 3) inactivation of the viral DNA polymerase. The greater antiviral activity of acyclovir against HSV compared to VZV is due to its more efficient phosphorylation by the viral TK. Antiviral Activities:The quantitative relationship between the in vitrosusceptibility of herpes viruses to antivirals and the clinical response to therapy has not been established in humans, and virus sensitivity testing has not been standardized. Sensitivity testing results, expressed as the concentration of drug required to inhibit by 50% the growth of virus in cell culture (IC 50), vary greatly depending upon a number of factors. Using plaque-reduction assays, the IC 50against herpes simplex virus isolates ranges from 0.02 to 13.5 mcg/mL for HSV-1 and from 0.01 to 9.9 mcg/mL for HSV-2. The IC 50for acyclovir against most laboratory strains and clinical isolates of VZV ranges from 0.12 to 10.8 mcg/mL. Acyclovir also demonstrates activity against the Oka vaccine strain of VZV with a mean IC 50of 1.35 mcg/mL. Drug Resistance:Resistance of HSV and VZV to acyclovir can result from qualitative and quantitative changes in the viral TK and/or DNA polymerase. Clinical isolates of HSV and VZV with reduced susceptibility to acyclovir have been recovered from immunocompromised patients, especially with advanced HIV infection. While most of the acyclovir-resistant mutants isolated thus far from immunocompromised patients have been found to be TK-deficient mutants, other mutants involving the viral TK gene (TK partial and TK altered) and DNA polymerase have been isolated. TK-negative mutants may cause severe disease in infants and immunocompromised adults. The possibility of viral resistance to acyclovir should be considered in patients who show poor clinical response during therapy."
},
{
"NDCCode": "17856-0111-4",
"PackageDescription": "72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0111-4) > 15 mL in 1 CUP, UNIT-DOSE",
"NDC11Code": "17856-0111-04",
"ProductNDC": "17856-0111",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Good Neighbor Pharmacy Loperamide Hydrochloride",
"NonProprietaryName": "Loperamide Hcl",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20190226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091292",
"LabelerName": "ATLANTIC BIOLOGICALS CORP.",
"SubstanceName": "LOPERAMIDE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/7.5mL",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210125",
"SamplePackage": "N",
"IndicationAndUsage": "controls symptoms of diarrhea, including Travelers’ Diarrhea."
},
{
"NDCCode": "17856-0125-2",
"PackageDescription": "72 CUP, UNIT-DOSE in 1 BOX (17856-0125-2) / 5 mL in 1 CUP, UNIT-DOSE (17856-0125-4) ",
"NDC11Code": "17856-0125-02",
"ProductNDC": "17856-0125",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenohytro",
"NonProprietaryName": "Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, And Scopolamine Hydrobromide",
"DosageFormName": "ELIXIR",
"RouteName": "ORAL",
"StartMarketingDate": "20180830",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "ATLANTIC BIOLOGICALS CORP.",
"SubstanceName": "PHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE",
"StrengthNumber": "16.2; .1037; .0194; .0065",
"StrengthUnit": "mg/5mL; mg/5mL; mg/5mL; mg/5mL",
"Pharm_Classes": "Anticholinergic [EPC], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2026-05-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240408",
"SamplePackage": "N",
"IndicationAndUsage": "Based on the National Academy of Sciences-National Research Council's review of this drug and/or other information, FDA has classified the following indications as \"possibly\" effective: For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. May also be useful as adjunctive therapy in the treatment of duodenal ulcer. IT HAS NOT BEEN SHOWN CONCLUSIVELY WHETHER ANTICHOLINERGIC / ANTISPASMODIC DRUGS AID IN THE HEALING OF A DUODENAL ULCER, DECREASE THE RATE OF RECURRENCES, OR PREVENT COMPLICATIONS."
},
{
"NDCCode": "17856-0138-2",
"PackageDescription": "50 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0138-2) / 20 mL in 1 CUP, UNIT-DOSE (17856-0138-4) ",
"NDC11Code": "17856-0138-02",
"ProductNDC": "17856-0138",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hydrochloride",
"NonProprietaryName": "Lidocaine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL; TOPICAL",
"StartMarketingDate": "20230328",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216780",
"LabelerName": "ATLANTIC BIOLOGICALS CORP.",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2025-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230919",
"SamplePackage": "N",
"IndicationAndUsage": "Lidocaine Hydrochloride Oral Topical Solution 2% (Viscous) is indicated for the production of topical anesthesia of irritated or inflamed mucous membranes of the mouth and pharynx. It is also useful for reducing gagging during the taking of X-ray pictures and dental impressions.",
"Description": "Lidocaine Hydrochloride Oral Topical Solution USP, 2% (Viscous) contains a local anesthetic agent and is administered topically. Lidocaine Hydrochloride Oral Topical Solution USP, 2% (Viscous) contains lidocaine hydrochloride, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the following structural formula. The molecular formula of lidocaine is C 14H 22N 2O. The molecular weight is 234.34."
},
{
"NDCCode": "17856-0141-4",
"PackageDescription": "120 SYRINGE in 1 BOX, UNIT-DOSE (17856-0141-4) > 2.5 mL in 1 SYRINGE",
"NDC11Code": "17856-0141-04",
"ProductNDC": "17856-0141",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Childrens Silapap",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20210115",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "ATLANTIC BIOLOGICALS CORP.",
"SubstanceName": "ACETAMINOPHEN",
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"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"IndicationAndUsage": "Uses To reduce fever and for the temporary relief of minor aches and pains due to: : 1 Headache, 2 Muscular aches, 3 Backache, 4 Minor pain of arthritis, 5 The common cold, 6 Toothache, 7 Premenstrual and menstrual cramps."
},
{
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"ProprietaryName": "Phenobarbital With Belladonna Alkaloids",
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"StrengthUnit": "mg/5mL; mg/5mL; mg/5mL; mg/5mL",
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"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"IndicationAndUsage": "Possibly effective for use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. May also be useful as adjunctive therapy in the treatment of duodenal ulcer. IT HAS NOT BEEN SHOWN CONCLUSIVELY WHETHER ANTICHOLINERGIC/ANTISPASMODIC DRUGS AID IN THE HEALING OF A DUODENAL ULCER, DECREASE THE RATE OF RECURRENCES OR PREVENT COMPLICATIONS.",
"Description": "Each 5 mL (teaspoonful) of elixir contains. Phenobarbital, USP ................................................... 16.2 mg. Hyoscyamine Sulfate, USP ................................... 0.1037 mg. Atropine Sulfate, USP ........................................... 0.0194 mg. Scopolamine Hydrobromide, USP ......................... 0.0065 mg."
},
{
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"IndicationAndUsage": "trmporarily: 1 reduces fever , 2 relieves minor aches and pains due to: , 3 the common cold , 4 flu, 5 headache, 6 sore throat, 7 toothache."
},
{
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"LabelerName": "ATLANTIC BIOLOGICALS CORP.",
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"IndicationAndUsage": "temporarily relieves: 1 cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants, 2 the impulse to cough to help you get to sleep."
},
{
"NDCCode": "17856-0174-1",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"IndicationAndUsage": "A. Sedative. B. Anticonvulsant- For the treatment of generalized and partial seizures.",
"Description": "The barbiturates are nonselective central nervous system (CNS) depressants that are primarily used as sedative-hypnotics. In subhypnotic doses, they are also used as anticonvulsants. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act. Phenobarbital is a barbituric acid derivative and occurs as white, odorless, small crystals or crystalline powder that is very slightly soluble in water; soluble in alcohol, in either, and in solutions of fixed alkali hydroxides and carbonates; sparingly soluble in chloroform. Phenobarbital is 5-ethyl-5-phenylbarbituric acid and has the empirical formula C12H12N2O3. Its molecular weight is 232.24. It has the following structural formula. Phenobarbital is a substituted pyrimidine derivative in which the basic structure is barbituric acid, a substance that has no CNS activity. CNS activity is obtained by substituting alkyl, alkenyl, or aryl groups on the pyrimidine ring. Each 5 mL (teaspoon) contains 20 mg Phenobarbital and Alcohol 15%. The oral solution also contains FD&C Red #40, glycerin, orange flavor, purified water, and sucrose."
},
{
"NDCCode": "17856-0175-6",
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}
]
}
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<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
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<PackageDescription>1 KIT in 1 KIT (0498-4069-01) * .4 mL in 1 POUCH * .9 g in 1 PACKET (0498-0730-01) * .9 g in 1 PACKET * 1.4 mL in 1 PACKET * 2 TABLET in 1 PACKET (0498-2001-01) * 30 mL in 1 BOTTLE (0498-0100-01) </PackageDescription>
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<LabelerName>Honeywell Safety Products USA, INC</LabelerName>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
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<NDCCode>37662-4069-4</NDCCode>
<PackageDescription>10000 PELLET in 1 BOTTLE, GLASS (37662-4069-4) </PackageDescription>
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<ProductNDC>37662-4069</ProductNDC>
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<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>STRONTIUM NITRATE</SubstanceName>
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<StrengthUnit>[hp_M]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-10-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>0093-4069-01</NDCCode>
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<ProductNDC>0093-4069</ProductNDC>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<Description>Prazosin hydrochloride, USP a quinazoline derivative, is the first of a new chemical class of antihypertensives. It is the hydrochloride salt of 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is. C19H21N5O4HCl M.W. 419.87. It is a white, crystalline substance, slightly soluble in water and isotonic saline. Each capsule for oral administration, contains prazosin hydrochloride, USP equivalent to 1 mg, 2 mg or 5 mg of prazosin. Inactive ingredients include: anhydrous lactose, magnesium stearate, and pregelatinized starch. Additional inactive ingredients for the gelatin capsule include: 1 mg (Ivory): D&C Yellow No. 10 and titanium dioxide; 2 mg (Pink): FD&C Blue No. 1, FD&C Red No. 40, D&C Red No. 28, and titanium dioxide; 5 mg (Light Blue): FD&C Blue No. 1 and titanium dioxide.</Description>
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<NDCCode>0093-4069-05</NDCCode>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Prazosin hydrochloride capsules USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal 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, including this drug. Control of high blood pressure 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 blood pressure 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 blood pressure 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 blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure 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 blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Prazosin hydrochloride capsules USP can be used alone or in combination with other antihypertensive drugs such as diuretics or beta-adrenergic blocking agents.</IndicationAndUsage>
<Description>Prazosin hydrochloride, USP a quinazoline derivative, is the first of a new chemical class of antihypertensives. It is the hydrochloride salt of 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is. C19H21N5O4HCl M.W. 419.87. It is a white, crystalline substance, slightly soluble in water and isotonic saline. Each capsule for oral administration, contains prazosin hydrochloride, USP equivalent to 1 mg, 2 mg or 5 mg of prazosin. Inactive ingredients include: anhydrous lactose, magnesium stearate, and pregelatinized starch. Additional inactive ingredients for the gelatin capsule include: 1 mg (Ivory): D&C Yellow No. 10 and titanium dioxide; 2 mg (Pink): FD&C Blue No. 1, FD&C Red No. 40, D&C Red No. 28, and titanium dioxide; 5 mg (Light Blue): FD&C Blue No. 1 and titanium dioxide.</Description>
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<NDCCode>0093-4069-52</NDCCode>
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<LastUpdate>2024-11-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Prazosin hydrochloride capsules USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal 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, including this drug. Control of high blood pressure 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 blood pressure 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 blood pressure 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 blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure 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 blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Prazosin hydrochloride capsules USP can be used alone or in combination with other antihypertensive drugs such as diuretics or beta-adrenergic blocking agents.</IndicationAndUsage>
<Description>Prazosin hydrochloride, USP a quinazoline derivative, is the first of a new chemical class of antihypertensives. It is the hydrochloride salt of 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is. C19H21N5O4HCl M.W. 419.87. It is a white, crystalline substance, slightly soluble in water and isotonic saline. Each capsule for oral administration, contains prazosin hydrochloride, USP equivalent to 1 mg, 2 mg or 5 mg of prazosin. Inactive ingredients include: anhydrous lactose, magnesium stearate, and pregelatinized starch. Additional inactive ingredients for the gelatin capsule include: 1 mg (Ivory): D&C Yellow No. 10 and titanium dioxide; 2 mg (Pink): FD&C Blue No. 1, FD&C Red No. 40, D&C Red No. 28, and titanium dioxide; 5 mg (Light Blue): FD&C Blue No. 1 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>50090-4069-0</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50090-4069-0) </PackageDescription>
<NDC11Code>50090-4069-00</NDC11Code>
<ProductNDC>50090-4069</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desvenlafaxine Succinate</ProprietaryName>
<NonProprietaryName>Desvenlafaxine Succinate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170301</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021992</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>DESVENLAFAXINE SUCCINATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190118</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desvenlafaxine is indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Desvenlafaxine is an extended-release tablet for oral administration that contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the empirical formula of C16H25NO2 (free base) and C16H25NO2∙C4H6O4∙H2O (succinate monohydrate). Desvenlafaxine succinate monohydrate has a molecular weight of 399.48. The structural formula is shown below. Desvenlafaxine succinate is a white to off-white powder that is soluble in water. The solubility of desvenlafaxine succinate is pH dependent. Its octanol:aqueous system (at pH 7.0) partition coefficient is 0.21. Desvenlafaxine is formulated as an extended-release tablet for once-a-day oral administration. Each tablet contains 38 mg, 76 mg or 152 mg of desvenlafaxine succinate equivalent to 25 mg, 50 mg or 100 mg of desvenlafaxine, respectively. Inactive ingredients for the 25 mg tablet consist of hypromellose, microcrystalline cellulose, talc, magnesium stearate, a film coating which consists of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, and iron oxides. Inactive ingredients for the 50 mg tablet consist of hypromellose, microcrystalline cellulose, talc, magnesium stearate and film coating, which consists of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, and iron oxides. Inactive ingredients for the 100 mg tablet consist of hypromellose, microcrystalline cellulose, talc, magnesium stearate and film coating, which consists of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, iron oxide and FD&C yellow #6.</Description>
</NDC>
<NDC>
<NDCCode>51672-4069-1</NDCCode>
<PackageDescription>237 mL in 1 BOTTLE (51672-4069-1) </PackageDescription>
<NDC11Code>51672-4069-01</NDC11Code>
<ProductNDC>51672-4069</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenytoin</ProprietaryName>
<NonProprietaryName>Phenytoin</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040408</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040521</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>PHENYTOIN</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040408</StartMarketingDatePackage>
<EndMarketingDatePackage>20260731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phenytoin oral suspension is indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures.</IndicationAndUsage>
<Description>Phenytoin is related to the barbiturates in chemical structure, but has a five-membered ring. The chemical name is 5,5-diphenyl-2,4 imidazolidinedione, having the following structural formula. Each 5 mL of the oral suspension contains 125 mg of phenytoin, USP; carboxymethylcellulose sodium, citric acid anhydrous, FD&C yellow no. 6, magnesium aluminum silicate, orange flavor spray dry natural and artificial, polysorbate 60, purified water, sodium benzoate, sucrose and vanilla flavored powder artificial.</Description>
</NDC>
<NDC>
<NDCCode>51672-4069-2</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (51672-4069-2) / 237 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>51672-4069-02</NDC11Code>
<ProductNDC>51672-4069</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenytoin</ProprietaryName>
<NonProprietaryName>Phenytoin</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040408</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040521</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>PHENYTOIN</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250723</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phenytoin oral suspension is indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures.</IndicationAndUsage>
<Description>Phenytoin is related to the barbiturates in chemical structure, but has a five-membered ring. The chemical name is 5,5-diphenyl-2,4 imidazolidinedione, having the following structural formula. Each 5 mL of the oral suspension contains 125 mg of phenytoin, USP; carboxymethylcellulose sodium, citric acid anhydrous, FD&C yellow no. 6, magnesium aluminum silicate, orange flavor spray dry natural and artificial, polysorbate 60, purified water, sodium benzoate, sucrose and vanilla flavored powder artificial.</Description>
</NDC>
<NDC>
<NDCCode>17856-0010-4</NDCCode>
<PackageDescription>100 DOSE PACK in 1 CONTAINER (17856-0010-4) > 1 TABLET, COATED in 1 DOSE PACK</PackageDescription>
<NDC11Code>17856-0010-04</NDC11Code>
<ProductNDC>17856-0010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dialyvite</ProprietaryName>
<NonProprietaryName>Ascorbic Acid, Thiamine, Riboflavin, Niacinamide, Pyridoxine, Folic Acid, Cobalamin, Biotin, Pantothenic Acid</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19880801</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Atlantic Biologicals Corps</LabelerName>
<SubstanceName>ASCORBIC ACID; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; COBALAMIN; BIOTIN; CALCIUM PANTOTHENATE</SubstanceName>
<StrengthNumber>100; 1.5; 1.7; 20; 10; 1; 6; 300; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1</StrengthUnit>
<Pharm_Classes>Vitamin C [EPC],Ascorbic Acid [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Dialyvite is a prescription folic acid supplement with additional nutrients indicated for use in improving the nutritional status of renal dialysis patients.</IndicationAndUsage>
<Description>Dialyvite is a prescription folic acid supplement with additional nutrients for kidney dialysis patients. Dialyvite is a small, round, light pink, clear-coated tablet, with debossed "H" on one side. Each tablet contains. Folic Acid.....1 mg. Vitamin C (Ascorbic Acid).....100 mg. Thiamine (Thiamine Mononitrate).....1.5 mg. Riboflavin.....1.7 mg. Niacinamide.....20 mg. Vitamin B6 (Pyridoxine HCl).....10 mg. Vitamin B12 (Methylcobalamin).....6 mcg. Biotin.....300 mcg. Pantothenic Acid (Calcium Pantothenate).....10 mg. Inactive ingredients. Microcrystalline Cellulose, Croscarmellose Sodium, Mono- and Diglycerides, Starch, Hypromellose, Polyethylene Glycol, Calcium Stearate, Carmine (color).</Description>
</NDC>
<NDC>
<NDCCode>17856-0016-4</NDCCode>
<PackageDescription>7.5 mL in 1 SYRINGE (17856-0016-4) </PackageDescription>
<NDC11Code>17856-0016-04</NDC11Code>
<ProductNDC>17856-0016</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenobarbital</ProprietaryName>
<NonProprietaryName>Phenobarbital</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180303</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>ATLANTIC BIOLOGICALS CORP</LabelerName>
<SubstanceName>PHENOBARBITAL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180316</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>A. Sedative. B. Anticonvulsant- For the treatment of generalized and partial seizures.</IndicationAndUsage>
<Description>The barbiturates are nonselective central nervous system (CNS) depressants that are primarily used as sedative-hypnotics. In subhypnotic doses, they are also used as anticonvulsants. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act. Phenobarbital is a barbituric acid derivative and occurs as white, odorless, small crystals or crystalline powder that is very slightly soluble in water; soluble in alcohol, in either, and in solutions of fixed alkali hydroxides and carbonates; sparingly soluble in chloroform. Phenobarbital is 5-ethyl-5-phenylbarbituric acid and has the empirical formula C12H12N2O3. Its molecular weight is 232.24. It has the following structural formula. Phenobarbital is a substituted pyrimidine derivative in which the basic structure is barbituric acid, a substance that has no CNS activity. CNS activity is obtained by substituting alkyl, alkenyl, or aryl groups on the pyrimidine ring. Each 5 mL (teaspoon) contains 20 mg Phenobarbital and Alcohol 15%. The oral solution also contains FD&C Red #40, orange flavor, glycerin, sucrose, and water.</Description>
</NDC>
<NDC>
<NDCCode>17856-0023-4</NDCCode>
<PackageDescription>60 SYRINGE in 1 BOX, UNIT-DOSE (17856-0023-4) / 1 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>17856-0023-04</NDC11Code>
<ProductNDC>17856-0023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209897</ApplicationNumber>
<LabelerName>ALTANTIC BIOLOGICALS CORP</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230309</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone Hydrochloride Oral Solution is an opioid agonist indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. (1). Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/mL) is indicated for the relief of pain in opioid-tolerant adults. Limitations of Use (1) Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Oxycodone Hydrochloride 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>Oxycodone Hydrochloride Oral Solution is an agonist, available as a yellow solution 100 mg/5 mL (20 mg/mL) for oral administration. The chemical name is (5R,9R,13S,14S)-4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 351.82. Its molecular formula is C18H21NO4.HCl, and it has the following chemical structure. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine.It is soluble in water and slightly soluble in alcohol. The inactive ingredients in Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/ mL): include: citric acid anhydrous, D&C Yellow #10, mixed berry flavor, purified water, sodium citrate dihydrate, sodium benzoate, saccharin sodium, sorbitol.</Description>
</NDC>
<NDC>
<NDCCode>17856-0025-4</NDCCode>
<PackageDescription>48 SYRINGE in 1 BOX, UNIT-DOSE (17856-0025-4) / 5 mL in 1 SYRINGE (17856-0025-8) </PackageDescription>
<NDC11Code>17856-0025-04</NDC11Code>
<ProductNDC>17856-0025</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Max Relief Junior</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230514</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M</ApplicationNumber>
<LabelerName>ATLANTIC BIOLOGICALS CORP.</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-03-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 temporarily , 2 reduces fever, 3 relieves minor aches and pains due to:, 4 the common cold, 5 flu, 6 headache, 7 sore throat, 8 toothache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>17856-0045-4</NDCCode>
<PackageDescription>120 SYRINGE in 1 BOX, UNIT-DOSE (17856-0045-4) / 2.5 mL in 1 SYRINGE (17856-0045-8) </PackageDescription>
<NDC11Code>17856-0045-04</NDC11Code>
<ProductNDC>17856-0045</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Max Relief Junior</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230514</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M</ApplicationNumber>
<LabelerName>ATLANTIC BIOLOGICALS CORP.</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 temporarily , 2 reduces fever, 3 relieves minor aches and pains due to:, 4 the common cold, 5 flu, 6 headache, 7 sore throat, 8 toothache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>17856-0048-3</NDCCode>
<PackageDescription>50 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0048-3) / 30 mL in 1 CUP, UNIT-DOSE (17856-0048-4) </PackageDescription>
<NDC11Code>17856-0048-03</NDC11Code>
<ProductNDC>17856-0048</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride</ProprietaryName>
<NonProprietaryName>Potassium Chloride Oral</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231005</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211648</ApplicationNumber>
<LabelerName>ATLANTIC BIOLOGICALS CORP.</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>g/15mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240711</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium chloride oral solution is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient.</IndicationAndUsage>
<Description>Potassium chloride, USP is a white crystalline powder or colorless crystals. It is freely soluble in water and practically insoluble in ethanol. Chemically, potassium chloride, USP is K-Cl with a molecular mass of 74.55. Oral Solution 10%: Each 15 mL of solution contains 1.5 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow No. 6, glycerin, methylparaben, natural & artificial orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose. Oral Solution 20%: Each 15 mL of solution contains 3.0 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow No. 6,glycerin, methylparaben, natural & artificial orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose.</Description>
</NDC>
<NDC>
<NDCCode>17856-0060-4</NDCCode>
<PackageDescription>50 CUP in 1 BOX (17856-0060-4) / 20 mL in 1 CUP (17856-0060-2) </PackageDescription>
<NDC11Code>17856-0060-04</NDC11Code>
<ProductNDC>17856-0060</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Megestrol Acetate</ProprietaryName>
<NonProprietaryName>Megestrol Acetate</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220321</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075671</ApplicationNumber>
<LabelerName>ATLANTIC BIOLOGICALS CORP.</LabelerName>
<SubstanceName>MEGESTROL ACETATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240509</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Megestrol acetate oral suspension, USP is indicated for the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS).</IndicationAndUsage>
<Description>Megestrol Acetate Oral Suspension, USP contains megestrol acetate, a synthetic derivative of the steroid hormone, progesterone. Megestrol acetate is a white, crystalline solid chemically designated as 17-Hydroxy-6-methylpregna-4,6-diene-3,20-dione acetate. Solubility at 37°C in water is 2 mcg per mL, solubility in plasma is 24 mcg per mL. Its molecular weight is 384.52. The chemical formula is C 24H 32O 4and the structural formula is represented as follows:. Megestrol acetate oral suspension is supplied as an oral suspension containing 40 mg of micronized megestrol acetate per mL. Megestrol acetate oral suspension contains the following inactive ingredients: alcohol (max 0.06% v/v from flavor), artificial lime flavor, citric acid monohydrate, docusate sodium, glycerin, natural and artificial lemon flavor, purified water, sodium benzoate, sodium citrate dihydrate, sucrose and xanthan gum. Megestrol acetate oral suspension, 40 mg/mL complies with USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>17856-0063-4</NDCCode>
<PackageDescription>48 SYRINGE in 1 BOX, UNIT-DOSE (17856-0063-4) / 4 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>17856-0063-04</NDC11Code>
<ProductNDC>17856-0063</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090729</StartMarketingDate>
<EndMarketingDate>20240531</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076904</ApplicationNumber>
<LabelerName>ATLANTIC BIOLOGICALS CORP.</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20240513</StartMarketingDatePackage>
<EndMarketingDatePackage>20240531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>17856-0067-3</NDCCode>
<PackageDescription>4 mL in 1 CUP (17856-0067-3)</PackageDescription>
<NDC11Code>17856-0067-03</NDC11Code>
<ProductNDC>17856-0067</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenytoin</ProprietaryName>
<NonProprietaryName>Phenytoin</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020624</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040420</ApplicationNumber>
<LabelerName>Atlantic Biologicals Corps</LabelerName>
<SubstanceName>PHENYTOIN</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Phenytoin Oral Suspension is indicated for the control of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures. Phenytoin serum level determinations may be necessary for optimal dosage adjustments (see and sections). DOSAGE AND ADMINISTRATIONCLINICAL PHARMACOLOGY.</IndicationAndUsage>
<Description>Phenytoin is related to the barbiturates in chemical structure, but has a five-membered ring. The chemical name is 5,5-Diphenylhydantoin, having the following structural formula. Each 5 mL (teaspoonful) of suspension contains 125 mg of phenytoin, USP with an alcohol content of 0.35 percent. Also contains carboxymethylcellulose sodium, citric acid anhydrous, dehydrated alcohol, FD&C Yellow No. 6, glycerin, liquid sugar, magnesium aluminum silicate, orange flavor, polysorbate 40, purified water, sodium benzoate, sodium citrate dihydrate and vanillin. It may contain 10% citric acid solution or 10% sodium citrate solution to adjust pH. The pH range is between 3.6 and 5.2.</Description>
</NDC>
<NDC>
<NDCCode>17856-0079-4</NDCCode>
<PackageDescription>12 mL in 1 CUP (17856-0079-4) </PackageDescription>
<NDC11Code>17856-0079-04</NDC11Code>
<ProductNDC>17856-0079</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen And Codeine Phosphate</ProprietaryName>
<NonProprietaryName>Acetaminophen And Codeine Phosphate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19960426</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040119</ApplicationNumber>
<LabelerName>ATLANTIC BIOLOGICALS COPR.</LabelerName>
<SubstanceName>ACETAMINOPHEN; CODEINE PHOSPHATE</SubstanceName>
<StrengthNumber>120; 12</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210112</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acetaminophen and codeine phosphate oral solution is indicated for the relief of mild to moderate pain.</IndicationAndUsage>
<Description>Acetaminophen and codeine phosphate oral solution is pharmacologically classified as an analgesic. Acetaminophen, 4’-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, nonsalicylate analgesic and antipyretic. It has the following structural formula. Codeine phosphate, 7,8-didehydro- 4, 5α-epoxy-3- methoxy-17-methylmorphinan- 6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula. Each 5 mL, for oral administration, contains. Acetaminophen 120 mg. Codeine Phosphate 12 mg. (Warning: May be habit forming). Alcohol 7%. In addition the following inactive ingredients are present: artificial cherry flavor, citric acid, FD&C Yellow No. 6, propylene glycol, purified water, saccharin sodium, sodium benzoate, and sucrose.</Description>
</NDC>
<NDC>
<NDCCode>17856-0083-1</NDCCode>
<PackageDescription>72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0083-1) / 5 mL in 1 CUP, UNIT-DOSE (17856-0083-4) </PackageDescription>
<NDC11Code>17856-0083-01</NDC11Code>
<ProductNDC>17856-0083</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020903</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074738</ApplicationNumber>
<LabelerName>ATLANTIC BIOLOGICALS CORP.</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240416</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Herpes Zoster Infections:Acyclovir is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes:Acyclovir is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox:Acyclovir is indicated for the treatment of chickenpox (varicella).</IndicationAndUsage>
<Description>Acyclovir is a synthetic nucleoside analogue active against herpes viruses. Acyclovir suspension is formulated for oral administration. Each teaspoonful (5 mL) of acyclovir oral suspension USP contains 200 mg of acyclovir and the inactive ingredients carboxymethylcellulose sodium, flavor, glycerin, methylparaben (0.1%), microcrystalline cellulose, propylparaben (0.02%), purified water and sorbitol. Acyclovir is a white, crystalline powder with the molecular formula C 8H 11N 5O 3, and a molecular weight of 225.20. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 9-[(2-Hydroxyethoxy)methyl]guanine; it has the following structural formula. VIROLOGY. Mechanism of Antiviral Action. Acyclovir is a synthetic purine nucleoside analogue with in vitroand in vivoinhibitory activity against herpes simplex virus types 1 (HSV-1), 2 (HSV-2), and varicella-zoster virus (VZV). The inhibitory activity of acyclovir is highly selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV and VZV. This viral enzyme converts acyclovir into acyclovir monophosphate, a nucleotide analogue. The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by a number of cellular enzymes. In vitro, acyclovir triphosphate stops replication of herpes viral DNA. This is accomplished in three ways: 1) competitive inhibition of viral DNA polymerase, 2) incorporation into and termination of the growing viral DNA chain, and 3) inactivation of the viral DNA polymerase. The greater antiviral activity of acyclovir against HSV compared to VZV is due to its more efficient phosphorylation by the viral TK. Antiviral Activities:The quantitative relationship between the in vitrosusceptibility of herpes viruses to antivirals and the clinical response to therapy has not been established in humans, and virus sensitivity testing has not been standardized. Sensitivity testing results, expressed as the concentration of drug required to inhibit by 50% the growth of virus in cell culture (IC 50), vary greatly depending upon a number of factors. Using plaque-reduction assays, the IC 50against herpes simplex virus isolates ranges from 0.02 to 13.5 mcg/mL for HSV-1 and from 0.01 to 9.9 mcg/mL for HSV-2. The IC 50for acyclovir against most laboratory strains and clinical isolates of VZV ranges from 0.12 to 10.8 mcg/mL. Acyclovir also demonstrates activity against the Oka vaccine strain of VZV with a mean IC 50of 1.35 mcg/mL. Drug Resistance:Resistance of HSV and VZV to acyclovir can result from qualitative and quantitative changes in the viral TK and/or DNA polymerase. Clinical isolates of HSV and VZV with reduced susceptibility to acyclovir have been recovered from immunocompromised patients, especially with advanced HIV infection. While most of the acyclovir-resistant mutants isolated thus far from immunocompromised patients have been found to be TK-deficient mutants, other mutants involving the viral TK gene (TK partial and TK altered) and DNA polymerase have been isolated. TK-negative mutants may cause severe disease in infants and immunocompromised adults. The possibility of viral resistance to acyclovir should be considered in patients who show poor clinical response during therapy.</Description>
</NDC>
<NDC>
<NDCCode>17856-0111-4</NDCCode>
<PackageDescription>72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0111-4) > 15 mL in 1 CUP, UNIT-DOSE</PackageDescription>
<NDC11Code>17856-0111-04</NDC11Code>
<ProductNDC>17856-0111</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Good Neighbor Pharmacy Loperamide Hydrochloride</ProprietaryName>
<NonProprietaryName>Loperamide Hcl</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190226</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091292</ApplicationNumber>
<LabelerName>ATLANTIC BIOLOGICALS CORP.</LabelerName>
<SubstanceName>LOPERAMIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/7.5mL</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210125</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>controls symptoms of diarrhea, including Travelers’ Diarrhea.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>17856-0125-2</NDCCode>
<PackageDescription>72 CUP, UNIT-DOSE in 1 BOX (17856-0125-2) / 5 mL in 1 CUP, UNIT-DOSE (17856-0125-4) </PackageDescription>
<NDC11Code>17856-0125-02</NDC11Code>
<ProductNDC>17856-0125</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenohytro</ProprietaryName>
<NonProprietaryName>Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, And Scopolamine Hydrobromide</NonProprietaryName>
<DosageFormName>ELIXIR</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180830</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>ATLANTIC BIOLOGICALS CORP.</LabelerName>
<SubstanceName>PHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE</SubstanceName>
<StrengthNumber>16.2; .1037; .0194; .0065</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240408</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Based on the National Academy of Sciences-National Research Council's review of this drug and/or other information, FDA has classified the following indications as "possibly" effective: For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. May also be useful as adjunctive therapy in the treatment of duodenal ulcer. IT HAS NOT BEEN SHOWN CONCLUSIVELY WHETHER ANTICHOLINERGIC / ANTISPASMODIC DRUGS AID IN THE HEALING OF A DUODENAL ULCER, DECREASE THE RATE OF RECURRENCES, OR PREVENT COMPLICATIONS.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>17856-0138-2</NDCCode>
<PackageDescription>50 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0138-2) / 20 mL in 1 CUP, UNIT-DOSE (17856-0138-4) </PackageDescription>
<NDC11Code>17856-0138-02</NDC11Code>
<ProductNDC>17856-0138</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL; TOPICAL</RouteName>
<StartMarketingDate>20230328</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216780</ApplicationNumber>
<LabelerName>ATLANTIC BIOLOGICALS CORP.</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230919</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocaine Hydrochloride Oral Topical Solution 2% (Viscous) is indicated for the production of topical anesthesia of irritated or inflamed mucous membranes of the mouth and pharynx. It is also useful for reducing gagging during the taking of X-ray pictures and dental impressions.</IndicationAndUsage>
<Description>Lidocaine Hydrochloride Oral Topical Solution USP, 2% (Viscous) contains a local anesthetic agent and is administered topically. Lidocaine Hydrochloride Oral Topical Solution USP, 2% (Viscous) contains lidocaine hydrochloride, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the following structural formula. The molecular formula of lidocaine is C 14H 22N 2O. The molecular weight is 234.34.</Description>
</NDC>
<NDC>
<NDCCode>17856-0141-4</NDCCode>
<PackageDescription>120 SYRINGE in 1 BOX, UNIT-DOSE (17856-0141-4) > 2.5 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>17856-0141-04</NDC11Code>
<ProductNDC>17856-0141</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Childrens Silapap</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210115</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>ATLANTIC BIOLOGICALS CORP.</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses To reduce fever and for the temporary relief of minor aches and pains due to: : 1 Headache, 2 Muscular aches, 3 Backache, 4 Minor pain of arthritis, 5 The common cold, 6 Toothache, 7 Premenstrual and menstrual cramps.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>17856-0162-4</NDCCode>
<PackageDescription>10 CUP, UNIT-DOSE in 1 BOX (17856-0162-4) > 10 mL in 1 CUP, UNIT-DOSE</PackageDescription>
<NDC11Code>17856-0162-04</NDC11Code>
<ProductNDC>17856-0162</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenobarbital With Belladonna Alkaloids</ProprietaryName>
<NonProprietaryName>Phenobarbital With Belladonna Alkaloids</NonProprietaryName>
<DosageFormName>ELIXIR</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180521</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>ATLANTIC BIOLOGICALS CORP.</LabelerName>
<SubstanceName>PHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE</SubstanceName>
<StrengthNumber>16.2; .1037; .0194; .0065</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Possibly effective for use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. May also be useful as adjunctive therapy in the treatment of duodenal ulcer. IT HAS NOT BEEN SHOWN CONCLUSIVELY WHETHER ANTICHOLINERGIC/ANTISPASMODIC DRUGS AID IN THE HEALING OF A DUODENAL ULCER, DECREASE THE RATE OF RECURRENCES OR PREVENT COMPLICATIONS.</IndicationAndUsage>
<Description>Each 5 mL (teaspoonful) of elixir contains. Phenobarbital, USP ................................................... 16.2 mg. Hyoscyamine Sulfate, USP ................................... 0.1037 mg. Atropine Sulfate, USP ........................................... 0.0194 mg. Scopolamine Hydrobromide, USP ......................... 0.0065 mg.</Description>
</NDC>
<NDC>
<NDCCode>17856-0166-3</NDCCode>
<PackageDescription>50 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0166-3) / 20.31 mL in 1 CUP, UNIT-DOSE (17856-0166-4) </PackageDescription>
<NDC11Code>17856-0166-03</NDC11Code>
<ProductNDC>17856-0166</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>ELIXIR</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210518</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>ATLANTIC BIOLOGICALS CORP</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230313</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>trmporarily: 1 reduces fever , 2 relieves minor aches and pains due to: , 3 the common cold , 4 flu, 5 headache, 6 sore throat, 7 toothache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>17856-0172-4</NDCCode>
<PackageDescription>1 BOX, UNIT-DOSE in 1 CUP, UNIT-DOSE (17856-0172-4) / 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0172-1) / 10 mL in 1 CUP, UNIT-DOSE</PackageDescription>
<NDC11Code>17856-0172-04</NDC11Code>
<ProductNDC>17856-0172</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Delsym</ProprietaryName>
<NonProprietaryName>Dextromethorphan</NonProprietaryName>
<DosageFormName>SUSPENSION, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181217</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018658</ApplicationNumber>
<LabelerName>ATLANTIC BIOLOGICALS CORP.</LabelerName>
<SubstanceName>DEXTROMETHORPHAN</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240419</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves: 1 cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants, 2 the impulse to cough to help you get to sleep.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>17856-0174-1</NDCCode>
<PackageDescription>72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0174-1) / 5 mL in 1 CUP, UNIT-DOSE (17856-0174-4) </PackageDescription>
<NDC11Code>17856-0174-01</NDC11Code>
<ProductNDC>17856-0174</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenobarbital</ProprietaryName>
<NonProprietaryName>Phenobarbital</NonProprietaryName>
<DosageFormName>ELIXIR</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190708</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>ATLANTIC BIOLOGICALS CORP</LabelerName>
<SubstanceName>PHENOBARBITAL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-05-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240605</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>A. Sedative. B. Anticonvulsant- For the treatment of generalized and partial seizures.</IndicationAndUsage>
<Description>The barbiturates are nonselective central nervous system (CNS) depressants that are primarily used as sedative-hypnotics. In subhypnotic doses, they are also used as anticonvulsants. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act. Phenobarbital is a barbituric acid derivative and occurs as white, odorless, small crystals or crystalline powder that is very slightly soluble in water; soluble in alcohol, in either, and in solutions of fixed alkali hydroxides and carbonates; sparingly soluble in chloroform. Phenobarbital is 5-ethyl-5-phenylbarbituric acid and has the empirical formula C12H12N2O3. Its molecular weight is 232.24. It has the following structural formula. Phenobarbital is a substituted pyrimidine derivative in which the basic structure is barbituric acid, a substance that has no CNS activity. CNS activity is obtained by substituting alkyl, alkenyl, or aryl groups on the pyrimidine ring. Each 5 mL (teaspoon) contains 20 mg Phenobarbital and Alcohol 15%. The oral solution also contains FD&C Red #40, glycerin, orange flavor, purified water, and sucrose.</Description>
</NDC>
<NDC>
<NDCCode>17856-0175-6</NDCCode>
<PackageDescription>5 BOX, UNIT-DOSE in 1 SYRINGE (17856-0175-6) > 120 SYRINGE in 1 BOX, UNIT-DOSE (17856-0175-4) > 2.5 mL in 1 SYRINGE (17856-0175-5) </PackageDescription>
<NDC11Code>17856-0175-06</NDC11Code>
<ProductNDC>17856-0175</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>ELIXIR</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210518</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>ATLANTIC BIOLOGICALS CORP.</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221025</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce fever and for the temporary relief of minor aches and pains due to: 1 headache , 2 muscular aches , 3 backache , 4 minor pain of arthritis , 5 the common cold, 6 toothache , 7 premenstrual and menstrual cramps. .</IndicationAndUsage>
</NDC>
</NDCList>