{
"NDC": [
{
"NDCCode": "23155-773-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (23155-773-10) ",
"NDC11Code": "23155-0773-10",
"ProductNDC": "23155-773",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enalapril Maleate",
"NonProprietaryName": "Enalapril Maleate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075479",
"LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
"SubstanceName": "ENALAPRIL MALEATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]",
"Status": "Active",
"LastUpdate": "2026-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201001",
"SamplePackage": "N",
"IndicationAndUsage": "Hypertension. Enalapril maleate tablets USP are indicated for the treatment of hypertension. Enalapril maleate tablets USP are effective alone or in combination with other antihypertensive agents, especially thiazide- type diuretics. The blood pressure lowering effects of enalapril maleate tablets USP and thiazides are approximately additive. Heart Failure. Enalapril maleate tablets USP are indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. In these patients enalapril maleate tablets USP improves symptoms, increases survival, and decreases the frequency of hospitalization (see CLINICAL PHARMACOLOGY, Heart Failure, Mortality Trials for details and limitations of survival trials). Asymptomatic Left Ventricular Dysfunction. In clinically stable asymptomatic patients with left ventricular dysfunction (ejection fraction ≤35 percent), enalapril maleate tablets USP decreases the rate of development of overt heart failure and decreases the incidence of hospitalization for heart failure (see CLINICAL PHARMACOLOGY, Heart Failure, Mortality Trials for details and limitations of survival trials). In using enalapril maleate tablets USP consideration should be given to the fact that another angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that enalapril maleate tablets USP does not have a similar risk (see WARNINGS, Neutropenia/Agranulocytosis). In considering use of enalapril maleate tablets USP, it should be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, it should be noted that black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-blacks (see WARNINGS, Head and Neck Angioedema).",
"Description": "Enalapril Maleate Tablets, USP is the maleate salt of enalapril, the ethyl ester of a long-acting angiotensin converting enzyme inhibitor, enalaprilat. Enalapril maleate is chemically described as (S)-1- [N-[1-(ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline, (Z)-2-butenedioate salt (1:1). Its empirical formula is C20H28N2O5C4H4O4, and its structural formula is. Enalapril maleate is a white to off-white, crystalline powder with a molecular weight of 492.53. It is sparingly soluble in water, soluble in ethanol, and freely soluble in methanol. Enalapril is a pro-drug; following oral administration, it is bioactivated by hydrolysis of the ethyl ester to enalaprilat, which is the active angiotensin-converting enzyme inhibitor. Enalapril Maleate Tablets, USP are supplied as 2.5 mg, 5 mg, 10 mg, and 20 mg tablets for oral administration. In addition to the active ingredient enalapril maleate, each tablet contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch, and sodium bicarbonate. Each 2.5 mg tablet contains D&C red #27 aluminum lake, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, and FD&C yellow #6 aluminum lake. Each 10 mg tablet contains FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake and FD&C yellow #6 aluminum lake. Each 20 mg tablet contains FD&C yellow #6 aluminum lake."
},
{
"NDCCode": "23155-773-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (23155-773-01) ",
"NDC11Code": "23155-0773-01",
"ProductNDC": "23155-773",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enalapril Maleate",
"NonProprietaryName": "Enalapril Maleate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075479",
"LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
"SubstanceName": "ENALAPRIL MALEATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]",
"Status": "Active",
"LastUpdate": "2026-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201001",
"SamplePackage": "N",
"IndicationAndUsage": "Hypertension. Enalapril maleate tablets USP are indicated for the treatment of hypertension. Enalapril maleate tablets USP are effective alone or in combination with other antihypertensive agents, especially thiazide- type diuretics. The blood pressure lowering effects of enalapril maleate tablets USP and thiazides are approximately additive. Heart Failure. Enalapril maleate tablets USP are indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. In these patients enalapril maleate tablets USP improves symptoms, increases survival, and decreases the frequency of hospitalization (see CLINICAL PHARMACOLOGY, Heart Failure, Mortality Trials for details and limitations of survival trials). Asymptomatic Left Ventricular Dysfunction. In clinically stable asymptomatic patients with left ventricular dysfunction (ejection fraction ≤35 percent), enalapril maleate tablets USP decreases the rate of development of overt heart failure and decreases the incidence of hospitalization for heart failure (see CLINICAL PHARMACOLOGY, Heart Failure, Mortality Trials for details and limitations of survival trials). In using enalapril maleate tablets USP consideration should be given to the fact that another angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that enalapril maleate tablets USP does not have a similar risk (see WARNINGS, Neutropenia/Agranulocytosis). In considering use of enalapril maleate tablets USP, it should be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, it should be noted that black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-blacks (see WARNINGS, Head and Neck Angioedema).",
"Description": "Enalapril Maleate Tablets, USP is the maleate salt of enalapril, the ethyl ester of a long-acting angiotensin converting enzyme inhibitor, enalaprilat. Enalapril maleate is chemically described as (S)-1- [N-[1-(ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline, (Z)-2-butenedioate salt (1:1). Its empirical formula is C20H28N2O5C4H4O4, and its structural formula is. Enalapril maleate is a white to off-white, crystalline powder with a molecular weight of 492.53. It is sparingly soluble in water, soluble in ethanol, and freely soluble in methanol. Enalapril is a pro-drug; following oral administration, it is bioactivated by hydrolysis of the ethyl ester to enalaprilat, which is the active angiotensin-converting enzyme inhibitor. Enalapril Maleate Tablets, USP are supplied as 2.5 mg, 5 mg, 10 mg, and 20 mg tablets for oral administration. In addition to the active ingredient enalapril maleate, each tablet contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch, and sodium bicarbonate. Each 2.5 mg tablet contains D&C red #27 aluminum lake, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, and FD&C yellow #6 aluminum lake. Each 10 mg tablet contains FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake and FD&C yellow #6 aluminum lake. Each 20 mg tablet contains FD&C yellow #6 aluminum lake."
},
{
"NDCCode": "23155-773-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (23155-773-05) ",
"NDC11Code": "23155-0773-05",
"ProductNDC": "23155-773",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enalapril Maleate",
"NonProprietaryName": "Enalapril Maleate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075479",
"LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
"SubstanceName": "ENALAPRIL MALEATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]",
"Status": "Active",
"LastUpdate": "2026-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201001",
"SamplePackage": "N",
"IndicationAndUsage": "Hypertension. Enalapril maleate tablets USP are indicated for the treatment of hypertension. Enalapril maleate tablets USP are effective alone or in combination with other antihypertensive agents, especially thiazide- type diuretics. The blood pressure lowering effects of enalapril maleate tablets USP and thiazides are approximately additive. Heart Failure. Enalapril maleate tablets USP are indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. In these patients enalapril maleate tablets USP improves symptoms, increases survival, and decreases the frequency of hospitalization (see CLINICAL PHARMACOLOGY, Heart Failure, Mortality Trials for details and limitations of survival trials). Asymptomatic Left Ventricular Dysfunction. In clinically stable asymptomatic patients with left ventricular dysfunction (ejection fraction ≤35 percent), enalapril maleate tablets USP decreases the rate of development of overt heart failure and decreases the incidence of hospitalization for heart failure (see CLINICAL PHARMACOLOGY, Heart Failure, Mortality Trials for details and limitations of survival trials). In using enalapril maleate tablets USP consideration should be given to the fact that another angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that enalapril maleate tablets USP does not have a similar risk (see WARNINGS, Neutropenia/Agranulocytosis). In considering use of enalapril maleate tablets USP, it should be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, it should be noted that black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-blacks (see WARNINGS, Head and Neck Angioedema).",
"Description": "Enalapril Maleate Tablets, USP is the maleate salt of enalapril, the ethyl ester of a long-acting angiotensin converting enzyme inhibitor, enalaprilat. Enalapril maleate is chemically described as (S)-1- [N-[1-(ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline, (Z)-2-butenedioate salt (1:1). Its empirical formula is C20H28N2O5C4H4O4, and its structural formula is. Enalapril maleate is a white to off-white, crystalline powder with a molecular weight of 492.53. It is sparingly soluble in water, soluble in ethanol, and freely soluble in methanol. Enalapril is a pro-drug; following oral administration, it is bioactivated by hydrolysis of the ethyl ester to enalaprilat, which is the active angiotensin-converting enzyme inhibitor. Enalapril Maleate Tablets, USP are supplied as 2.5 mg, 5 mg, 10 mg, and 20 mg tablets for oral administration. In addition to the active ingredient enalapril maleate, each tablet contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch, and sodium bicarbonate. Each 2.5 mg tablet contains D&C red #27 aluminum lake, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, and FD&C yellow #6 aluminum lake. Each 10 mg tablet contains FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake and FD&C yellow #6 aluminum lake. Each 20 mg tablet contains FD&C yellow #6 aluminum lake."
},
{
"NDCCode": "31722-773-32",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (31722-773-32) / 10 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "31722-0773-32",
"ProductNDC": "31722-773",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pomalidomide",
"NonProprietaryName": "Pomalidomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210236",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "POMALIDOMIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Thalidomide Analog [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260228",
"SamplePackage": "N",
"IndicationAndUsage": "Pomalidomide is a thalidomide analogue indicated for the treatment of adult patients: in combination with dexamethasone, for patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy ( 1.1).",
"Description": "Pomalidomide is a thalidomide analog. The chemical name is (RS)-4-Amino-2-(2,6-dioxo-piperidin-3-yl)-1H-isoindoline-1,3-dione and it has the following chemical structure. The molecular formula for pomalidomide is C 13H 11N 3O 4and the gram molecular weight is 273.24. Pomalidomide is a pale yellow to yellow color powder. Soluble in dimethylformamide and in dimethylsulfoxide. Pomalidomide has a chiral carbon atom which exists as a racemic mixture of the R(+) and S(-) enantiomers. Pomalidomide is available in 1 mg, 2 mg, 3 mg, and 4 mg capsules for oral administration. Each capsule contains pomalidomide as the active ingredient and the following inactive ingredients: black iron oxide, gelatin, mannitol, microcrystalline cellulose, potassium hydroxide, pregelatinized starch, propylene glycol, shellac, sodium stearyl fumarate, strong ammonia solution and titanium dioxide. In addition, the 2 mg and 3 mg capsules also contain iron oxide red. The 2 mg capsule also contains iron oxide yellow. The botanical source for pregelatinized starch is corn starch."
},
{
"NDCCode": "33261-773-10",
"PackageDescription": "10 CAPSULE in 1 BOTTLE, PLASTIC (33261-773-10)",
"NDC11Code": "33261-0773-10",
"ProductNDC": "33261-773",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amantadine Hydrochloride",
"NonProprietaryName": "Amantadine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19870218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071293",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "AMANTADINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Amantadine hydrochloride capsules are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions.",
"Description": "Amantadine hydrochloride is designated chemically as 1-adamantanamine hydrochloride. Its molecular weight is 187.71 with a molecular formula C10H18NCl. It has the following structural formula. Amantadine hydrochloride is a stable white or nearly white crystalline powder, freely soluble in water and soluble in alcohol and in chloroform. Amantadine hydrochloride has pharmacological actions as both an anti-Parkinson and an antiviral drug. Amantadine hydrochloride is available as 100 mg capsules for oral administration. Inactive ingredients: corn starch, croscarmellose sodium, ethylcellulose, FD&C Blue #1, FD&C Red #40, gelatin, magnesium stearate, methylparaben, microcrystalline cellulose, pregelatinized starch, propylparaben, sodium lauryl sulfate and titanium dioxide."
},
{
"NDCCode": "41520-773-01",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (41520-773-01) > 2 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "41520-0773-01",
"ProductNDC": "41520-773",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Careone Severe Cold",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160407",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "American Sales Company",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 10; 200; 5",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-11-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20160407",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these common cold and flu symptoms:. nasal congestion. headache. cough. minor aches and pains. sore throat. temporarily reduces fever. helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive."
},
{
"NDCCode": "46708-773-10",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (46708-773-10) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
"NDC11Code": "46708-0773-10",
"ProductNDC": "46708-773",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20260302",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217278",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260302",
"SamplePackage": "N",
"IndicationAndUsage": "Lamotrigine orally disintegrating tablets are indicated for:Epilepsy - adjunctive therapy in patients aged 2 years and older: partial-onset seizures. primary generalized tonic-clonic (PGTC) seizures. generalized seizures of Lennox-Gastaut syndrome. (1.1). Epilepsy - monotherapy in patients aged 16 years and older: Conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug. (1.1)Bipolar disorder: Maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy. (1.2) Limitations of Use: Treatment of acute manic or mixed episodes is not recommended. Effectiveness of lamotrigine orally disintegrating tablets in the acute treatment of mood episodes has not been established.",
"Description": "Lamotrigine, USP an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine is a white or almost white powder and has a pKa of 5.7. Lamotrigine is slightly soluble in anhydrous ethanol and in 0.1M hydrochloric acid. The structural formula is. Lamotrigine orally disintegrating tablets, USP are supplied for oral administration. The tablets contain 25 mg (white to off-white), 50 mg (white to off-white), 100 mg (white to off-white), or 200 mg (white to off-white) of lamotrigine, USP and the following inactive ingredients: amino methacrylate copolymer, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, sodium stearyl fumarate and sucralose. Composition of peppermint flavor: Maltodextrin, modified corn starch and natural flavours. Lamotrigine orally disintegrating tablets are formulated using granulation technology in which the lamotrigine drug substance is granulated with amino methacrylate copolymer for taste masking. The formulation contains flavor and has a good mouth feel, no grittiness, no after taste, better palatability and gives a desired dissolution profile."
},
{
"NDCCode": "55648-773-04",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (55648-773-04) > 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "55648-0773-04",
"ProductNDC": "55648-773",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole Hydrochloride",
"NonProprietaryName": "Ropinirole Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120815",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091395",
"LabelerName": "Wockhardt Limited",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Ropinirole Extended-release Tablet is an orally administered, non-ergoline dopamine agonist indicated for the treatment of signs and symptoms of idiopathic Parkinson’s disease. (1.1).",
"Description": "Ropinirole hydrochloride is an orally administered non-ergoline dopamine agonist. It is supplied as the hydrochloride salt of ropinirole 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and has an empirical formula of C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is:. Ropinirole hydrochloride is a white to cream crystalline powder solid with a melting range of 241° to 245°C and soluble in water and methanol, very slightly soluble in ethyl alcohol. Ropinirole Extended-release Tablets are formulated as film coated, circular shaped tablets with beveled edge. Ropinirole Extended-release Tablets are available in 2 mg (pink), 4 mg (light brown), 6 mg (white), 8 mg (brown) and 12 mg (green). Each tablet contains 2.28 mg, 4.56 mg, 6.84 mg, 9.12 mg, and 13.68 mg ropinirole hydrochloride equivalent to ropinirole 2 mg, 4 mg, 6 mg, 8 mg, and 12 mg, respectively. Inactive ingredients consist of carboxy methyl cellulose sodium, colloidal silicon dioxide, ethyl cellulose, hydrogenated castor oil, hydroxy propyl methyl cellulose 2910, hypromellose, magnesium stearate, maltodextrin, polyethylene glycol 400, pregelatinized starch, povidone, titanium dioxide and triethyl citrate. Ropinirole Extended-release Tablet 2 mg also contains iron oxide red and iron oxide yellow. Ropinirole Extended-release Tablet 4 mg also contains iron oxide yellow, iron oxide red and iron oxide black. Ropinirole Extended-release Tablet 8 mg also contains iron oxide red and FD&C blue # 2. Ropinirole Extended-release Tablet 12 mg also contains iron oxide yellow and FD&C blue # 2."
},
{
"NDCCode": "62207-773-58",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (62207-773-58) / 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "62207-0773-58",
"ProductNDC": "62207-773",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ranitidine",
"NonProprietaryName": "Ranitidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190626",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210243",
"LabelerName": "Granules India Ltd",
"SubstanceName": "RANITIDINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-10-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190626",
"SamplePackage": "N",
"IndicationAndUsage": "◾ relieves heartburn associated with acid indigestion and sour stomach ◾ prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages."
},
{
"NDCCode": "62332-773-10",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (62332-773-10) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
"NDC11Code": "62332-0773-10",
"ProductNDC": "62332-773",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20260302",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217278",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260302",
"SamplePackage": "N",
"IndicationAndUsage": "Lamotrigine orally disintegrating tablets are indicated for:Epilepsy - adjunctive therapy in patients aged 2 years and older: partial-onset seizures. primary generalized tonic-clonic (PGTC) seizures. generalized seizures of Lennox-Gastaut syndrome. (1.1). Epilepsy - monotherapy in patients aged 16 years and older: Conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug. (1.1)Bipolar disorder: Maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy. (1.2) Limitations of Use: Treatment of acute manic or mixed episodes is not recommended. Effectiveness of lamotrigine orally disintegrating tablets in the acute treatment of mood episodes has not been established.",
"Description": "Lamotrigine, USP an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine is a white or almost white powder and has a pKa of 5.7. Lamotrigine is slightly soluble in anhydrous ethanol and in 0.1M hydrochloric acid. The structural formula is. Lamotrigine orally disintegrating tablets, USP are supplied for oral administration. The tablets contain 25 mg (white to off-white), 50 mg (white to off-white), 100 mg (white to off-white), or 200 mg (white to off-white) of lamotrigine, USP and the following inactive ingredients: amino methacrylate copolymer, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, sodium stearyl fumarate and sucralose. Composition of peppermint flavor: Maltodextrin, modified corn starch and natural flavours. Lamotrigine orally disintegrating tablets are formulated using granulation technology in which the lamotrigine drug substance is granulated with amino methacrylate copolymer for taste masking. The formulation contains flavor and has a good mouth feel, no grittiness, no after taste, better palatability and gives a desired dissolution profile."
},
{
"NDCCode": "63304-773-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (63304-773-10) ",
"NDC11Code": "63304-0773-10",
"ProductNDC": "63304-773",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lorazepam",
"NonProprietaryName": "Lorazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230625",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076045",
"LabelerName": "SUN PHARMACEUTICAL INDUSTRIES INC",
"SubstanceName": "LORAZEPAM",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2023-07-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230625",
"SamplePackage": "N",
"IndicationAndUsage": "Lorazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Lorazepam USP, an antianxiety agent, has the chemical formula, 7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one. It is a white or practically white, crystalline powder, practically insoluble in water, sparingly soluble in Ethanol (96%), slightly soluble in Chloroform and Ether, sparingly or slightly soluble in Dichloromethane. Soluble in Acetone and glacial Acetic acid. Each lorazepam tablet, USP, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam, USP. The inactive ingredients present are lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polacrilin potassium."
},
{
"NDCCode": "63868-773-10",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (63868-773-10) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "63868-0773-10",
"ProductNDC": "63868-773",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19880524",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075010",
"LabelerName": "CHAIN DRUG MARKETING ASSOCIATION INC",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-10-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19880524",
"EndMarketingDatePackage": "20290331",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to: headachethe common coldmenstrual crampsbackachetoothache muscular achesminor pain of arthritis. temporarily reduces fever."
},
{
"NDCCode": "64679-773-04",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (64679-773-04) > 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "64679-0773-04",
"ProductNDC": "64679-773",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole Hydrochloride",
"NonProprietaryName": "Ropinirole Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120815",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091395",
"LabelerName": "Wockhardt USA LLC.",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20120815",
"SamplePackage": "N",
"IndicationAndUsage": "Ropinirole Extended-release Tablets are indicated for the treatment of Parkinson's disease.",
"Description": "Ropinirole extended-release tablet contains ropinirole, a non-ergoline dopamine agonist as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the molecular formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride, USP is a white to cream crystalline powder solid with a melting range of 241° to 245°C and soluble in water and methanol, very slightly soluble in ethyl alcohol. Ropinirole extended-release tablets are formulated as film coated, circular shaped tablets with beveled edge. Each tablet contains 2.28 mg, 4.56 mg, 6.84 mg, 9.12 mg, or 13.68 mg ropinirole hydrochloride equivalent to ropinirole 2 mg (pink), 4 mg (light brown), 6 mg (white), 8 mg (brown), or 12 mg (green), respectively. Inactive ingredients consist of carboxy methyl cellulose sodium, colloidal silicon dioxide, ethyl cellulose, hydrogenated castor oil, hydroxy propyl methyl cellulose 2910, hypromellose, magnesium stearate, maltodextrin, polyethylene glycol 400, pregelatinized starch, povidone, titanium dioxide and triethyl citrate. Ropinirole extended-release tablet 2 mg also contains iron oxide red and iron oxide yellow. Ropinirole extended-release tablet 4 mg also contains iron oxide yellow, iron oxide red and iron oxide black. Ropinirole extended-release tablet 8 mg also contains iron oxide red and FD&C blue # 2. Ropinirole extended-release tablet 12 mg also contains iron oxide yellow and FD&C blue # 2."
},
{
"NDCCode": "65841-773-77",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (65841-773-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65841-773-30) ",
"NDC11Code": "65841-0773-77",
"ProductNDC": "65841-773",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sirolimus",
"NonProprietaryName": "Sirolimus",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201676",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "SIROLIMUS",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-09-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230216",
"SamplePackage": "N"
},
{
"NDCCode": "66733-773-01",
"PackageDescription": "1 VIAL in 1 CARTON (66733-773-01) > 10 mL in 1 VIAL",
"NDC11Code": "66733-0773-01",
"ProductNDC": "66733-773",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Insulin Lispro",
"NonProprietaryName": "Insulin Lispro",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20190304",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA020563",
"LabelerName": "ImClone LLC",
"SubstanceName": "INSULIN LISPRO",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2022-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190319",
"SamplePackage": "N"
},
{
"NDCCode": "68382-773-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (68382-773-10) ",
"NDC11Code": "68382-0773-10",
"ProductNDC": "68382-773",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ezetimibe",
"NonProprietaryName": "Ezetimibe",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170809",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204331",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "EZETIMIBE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170809",
"SamplePackage": "N",
"IndicationAndUsage": "Ezetimibe tablets are indicated: 1 In combination with a statin, or alone when additional low-density lipoprotein cholesterol (LDL-C) lowering therapy is not possible, as an adjunct to diet to reduce elevated LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH). , 2 In combination with a statin as an adjunct to diet to reduce elevated LDL-C in pediatric patients 10 years of age and older with HeFH. , 3 In combination with fenofibrate as an adjunct to diet to reduce elevated LDL-C in adults with mixed hyperlipidemia. , 4 In combination with a statin, and other LDL-C lowering therapies, to reduce elevated LDL-C levels in adults and in pediatric patients 10 years of age and older with homozygous familial hypercholesterolemia (HoFH). , 5 As an adjunct to diet for the reduction of elevated sitosterol and campesterol levels in adults and in pediatric patients 9 years of age and older with homozygous familial sitosterolemia. .",
"Description": "Ezetimibe is a dietary cholesterol absorption inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3. Its molecular weight is 409.4 and its structural formula is. Ezetimibe, USP is a white to an off-white crystalline powder. It is freely soluble in methanol and acetone, soluble in ethanol and practically insoluble in water. Ezetimibe has a melting point of about 163°C and is stable at ambient temperature. Each ezetimibe tablet, USP available for oral administration contains 10 mg of ezetimibe. In addition, each tablet contains the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (botanical source: maize), sodium lauryl sulfate and sodium stearyl fumarate."
},
{
"NDCCode": "68382-773-77",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (68382-773-77) / 10 TABLET in 1 BLISTER PACK (68382-773-30) ",
"NDC11Code": "68382-0773-77",
"ProductNDC": "68382-773",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ezetimibe",
"NonProprietaryName": "Ezetimibe",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170809",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204331",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "EZETIMIBE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170809",
"SamplePackage": "N",
"IndicationAndUsage": "Ezetimibe tablets are indicated: 1 In combination with a statin, or alone when additional low-density lipoprotein cholesterol (LDL-C) lowering therapy is not possible, as an adjunct to diet to reduce elevated LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH). , 2 In combination with a statin as an adjunct to diet to reduce elevated LDL-C in pediatric patients 10 years of age and older with HeFH. , 3 In combination with fenofibrate as an adjunct to diet to reduce elevated LDL-C in adults with mixed hyperlipidemia. , 4 In combination with a statin, and other LDL-C lowering therapies, to reduce elevated LDL-C levels in adults and in pediatric patients 10 years of age and older with homozygous familial hypercholesterolemia (HoFH). , 5 As an adjunct to diet for the reduction of elevated sitosterol and campesterol levels in adults and in pediatric patients 9 years of age and older with homozygous familial sitosterolemia. .",
"Description": "Ezetimibe is a dietary cholesterol absorption inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3. Its molecular weight is 409.4 and its structural formula is. Ezetimibe, USP is a white to an off-white crystalline powder. It is freely soluble in methanol and acetone, soluble in ethanol and practically insoluble in water. Ezetimibe has a melting point of about 163°C and is stable at ambient temperature. Each ezetimibe tablet, USP available for oral administration contains 10 mg of ezetimibe. In addition, each tablet contains the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (botanical source: maize), sodium lauryl sulfate and sodium stearyl fumarate."
},
{
"NDCCode": "70069-773-10",
"PackageDescription": "10 VIAL, GLASS in 1 CARTON (70069-773-10) / 10 mL in 1 VIAL, GLASS",
"NDC11Code": "70069-0773-10",
"ProductNDC": "70069-773",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Calcium Chloride Dihydrate",
"NonProprietaryName": "Calcium Chloride Dihydrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20241219",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218133",
"LabelerName": "Somerset Therapeutics, LLC",
"SubstanceName": "CALCIUM CHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241219",
"SamplePackage": "N",
"IndicationAndUsage": "Calcium chloride injection is indicated for the treatment of adult and pediatric patients with acute symptomatic hypocalcemia. Limitations of Use. The safety and effectiveness of calcium chloride injection for long-term use has not been established.",
"Description": "10% Calcium chloride injection, USP is a sterile, nonpyrogenic, hypertonic solution for single administration only. Each mL contains 100 mg (1.4 mEq/mL) of calcium chloride, dihydrate (1.4 mEq each of Ca++ and Cl-) in water for injection. It is provided in a 10 mL single-dose vial for intravenous injection. The solution contains no bacteriostat, antimicrobial agent or added buffer. The pH of 10% calcium chloride injection, USP is 5.5 to 7.5 when diluted with water for injection to make a 5% solution. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. The osmolar concentration is 2.04 mOsmol/mL (calc.). 10% calcium chloride injection, USP is oxygen sensitive. Calcium chloride, USP dihydrate is chemically designated CaCl2 2H2O (dihydrate) and is described as white, odorless fragments or granules freely soluble in water. Calcium chloride injection, USP contains no more than 1,000 mcg/L of aluminum [see Warnings and Precautions (5.2)]."
},
{
"NDCCode": "70954-773-20",
"PackageDescription": "28 BLISTER PACK in 1 CARTON (70954-773-20) / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (70954-773-10) ",
"NDC11Code": "70954-0773-20",
"ProductNDC": "70954-773",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Everolimus",
"NonProprietaryName": "Everolimus",
"DosageFormName": "TABLET, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20251010",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA220597",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "EVEROLIMUS",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251010",
"SamplePackage": "N",
"IndicationAndUsage": "Everolimus tablets for oral suspension is a kinase inhibitor indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected (1.5). Everolimus tablets for oral suspension is a kinase inhibitor indicated for the adjunctive treatment of adult and pediatric patients aged 2 years and older with TSC-associated partial-onset seizures. (1.6).",
"Description": "Everolimus tablets for oral suspension are a kinase inhibitors. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18-dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.2 g/mol. The structural formula is. Everolimus tablets for oral suspension for oral administration contains 2 mg, 3 mg, or 5 mg of everolimus and the following inactive ingredients: butylhydroxytoluene, colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, mannitol, and microcrystalline cellulose."
},
{
"NDCCode": "82182-773-10",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (82182-773-10) / 10 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "82182-0773-10",
"ProductNDC": "82182-773",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Brimonidine Tartrate",
"NonProprietaryName": "Brimonidine Tartrate",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20220228",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021262",
"LabelerName": "Pacific Pharma, Inc.",
"SubstanceName": "BRIMONIDINE TARTRATE",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-10-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220228",
"SamplePackage": "N"
},
{
"NDCCode": "82907-773-10",
"PackageDescription": "10 g in 1 BOTTLE (82907-773-10) ",
"NDC11Code": "82907-0773-10",
"ProductNDC": "82907-773",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Elamipretide",
"DosageFormName": "POWDER",
"StartMarketingDate": "20230908",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Hangzhou Sinodo Pharm Technology Co.,Ltd",
"SubstanceName": "ELAMIPRETIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "08-SEP-23"
},
{
"NDCCode": "23155-001-10",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (23155-001-10) ",
"NDC11Code": "23155-0001-10",
"ProductNDC": "23155-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydralazine Hydrochloride",
"NonProprietaryName": "Hydralazine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070406",
"EndMarketingDate": "20260831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA086242",
"LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
"SubstanceName": "HYDRALAZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20070406",
"EndMarketingDatePackage": "20260831",
"SamplePackage": "N",
"IndicationAndUsage": "Essential hypertension, alone or as an adjunct.",
"Description": "HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose, lactose anhydrous, light mineral oil, microcrystalline cellulose, magnesium stearate, pregelatinized starch, sodium lauryl sulfate, and titanium dioxide."
},
{
"NDCCode": "23155-002-10",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (23155-002-10) ",
"NDC11Code": "23155-0002-10",
"ProductNDC": "23155-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydralazine Hydrochloride",
"NonProprietaryName": "Hydralazine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070406",
"EndMarketingDate": "20260831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA086242",
"LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
"SubstanceName": "HYDRALAZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20070406",
"EndMarketingDatePackage": "20260831",
"SamplePackage": "N",
"IndicationAndUsage": "Essential hypertension, alone or as an adjunct.",
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"IndicationAndUsage": "Hydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide tablets are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension. Use in Pregnancy. Routine use of diuretics during normal pregnancy is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of toxemia. Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Thiazides are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy (see PRECAUTIONS, Pregnancy). Dependent edema in pregnancy, resulting from restriction of venous return by the gravid uterus, is properly treated through elevation of the lower extremities and use of support stockings. Use of diuretics to lower intravascular volume in this instance is illogical and unnecessary. During normal pregnancy there is hypervolemia which is not harmful to the fetus or the mother in the absence of cardiovascular disease. However, it may be associated with edema, rarely generalized edema. If such edema causes discomfort, increased recumbency will often provide relief. Rarely this edema may cause extreme discomfort which is not relieved by rest. In these instances, a short course of diuretic therapy may provide relief and be appropriate.",
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypertension. Enalapril maleate tablets USP are indicated for the treatment of hypertension. Enalapril maleate tablets USP are effective alone or in combination with other antihypertensive agents, especially thiazide- type diuretics. The blood pressure lowering effects of enalapril maleate tablets USP and thiazides are approximately additive. Heart Failure. Enalapril maleate tablets USP are indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. In these patients enalapril maleate tablets USP improves symptoms, increases survival, and decreases the frequency of hospitalization (see CLINICAL PHARMACOLOGY, Heart Failure, Mortality Trials for details and limitations of survival trials). Asymptomatic Left Ventricular Dysfunction. In clinically stable asymptomatic patients with left ventricular dysfunction (ejection fraction ≤35 percent), enalapril maleate tablets USP decreases the rate of development of overt heart failure and decreases the incidence of hospitalization for heart failure (see CLINICAL PHARMACOLOGY, Heart Failure, Mortality Trials for details and limitations of survival trials). In using enalapril maleate tablets USP consideration should be given to the fact that another angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that enalapril maleate tablets USP does not have a similar risk (see WARNINGS, Neutropenia/Agranulocytosis). In considering use of enalapril maleate tablets USP, it should be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, it should be noted that black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-blacks (see WARNINGS, Head and Neck Angioedema).</IndicationAndUsage>
<Description>Enalapril Maleate Tablets, USP is the maleate salt of enalapril, the ethyl ester of a long-acting angiotensin converting enzyme inhibitor, enalaprilat. Enalapril maleate is chemically described as (S)-1- [N-[1-(ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline, (Z)-2-butenedioate salt (1:1). Its empirical formula is C20H28N2O5C4H4O4, and its structural formula is. Enalapril maleate is a white to off-white, crystalline powder with a molecular weight of 492.53. It is sparingly soluble in water, soluble in ethanol, and freely soluble in methanol. Enalapril is a pro-drug; following oral administration, it is bioactivated by hydrolysis of the ethyl ester to enalaprilat, which is the active angiotensin-converting enzyme inhibitor. Enalapril Maleate Tablets, USP are supplied as 2.5 mg, 5 mg, 10 mg, and 20 mg tablets for oral administration. In addition to the active ingredient enalapril maleate, each tablet contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch, and sodium bicarbonate. Each 2.5 mg tablet contains D&C red #27 aluminum lake, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, and FD&C yellow #6 aluminum lake. Each 10 mg tablet contains FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake and FD&C yellow #6 aluminum lake. Each 20 mg tablet contains FD&C yellow #6 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>31722-773-32</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 CARTON (31722-773-32) / 10 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>31722-0773-32</NDC11Code>
<ProductNDC>31722-773</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pomalidomide</ProprietaryName>
<NonProprietaryName>Pomalidomide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210236</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>POMALIDOMIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Thalidomide Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pomalidomide is a thalidomide analogue indicated for the treatment of adult patients: in combination with dexamethasone, for patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy ( 1.1).</IndicationAndUsage>
<Description>Pomalidomide is a thalidomide analog. The chemical name is (RS)-4-Amino-2-(2,6-dioxo-piperidin-3-yl)-1H-isoindoline-1,3-dione and it has the following chemical structure. The molecular formula for pomalidomide is C 13H 11N 3O 4and the gram molecular weight is 273.24. Pomalidomide is a pale yellow to yellow color powder. Soluble in dimethylformamide and in dimethylsulfoxide. Pomalidomide has a chiral carbon atom which exists as a racemic mixture of the R(+) and S(-) enantiomers. Pomalidomide is available in 1 mg, 2 mg, 3 mg, and 4 mg capsules for oral administration. Each capsule contains pomalidomide as the active ingredient and the following inactive ingredients: black iron oxide, gelatin, mannitol, microcrystalline cellulose, potassium hydroxide, pregelatinized starch, propylene glycol, shellac, sodium stearyl fumarate, strong ammonia solution and titanium dioxide. In addition, the 2 mg and 3 mg capsules also contain iron oxide red. The 2 mg capsule also contains iron oxide yellow. The botanical source for pregelatinized starch is corn starch.</Description>
</NDC>
<NDC>
<NDCCode>33261-773-10</NDCCode>
<PackageDescription>10 CAPSULE in 1 BOTTLE, PLASTIC (33261-773-10)</PackageDescription>
<NDC11Code>33261-0773-10</NDC11Code>
<ProductNDC>33261-773</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amantadine Hydrochloride</ProprietaryName>
<NonProprietaryName>Amantadine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19870218</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071293</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>AMANTADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Amantadine hydrochloride capsules are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions.</IndicationAndUsage>
<Description>Amantadine hydrochloride is designated chemically as 1-adamantanamine hydrochloride. Its molecular weight is 187.71 with a molecular formula C10H18NCl. It has the following structural formula. Amantadine hydrochloride is a stable white or nearly white crystalline powder, freely soluble in water and soluble in alcohol and in chloroform. Amantadine hydrochloride has pharmacological actions as both an anti-Parkinson and an antiviral drug. Amantadine hydrochloride is available as 100 mg capsules for oral administration. Inactive ingredients: corn starch, croscarmellose sodium, ethylcellulose, FD&C Blue #1, FD&C Red #40, gelatin, magnesium stearate, methylparaben, microcrystalline cellulose, pregelatinized starch, propylparaben, sodium lauryl sulfate and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>41520-773-01</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (41520-773-01) > 2 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>41520-0773-01</NDC11Code>
<ProductNDC>41520-773</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Careone Severe Cold</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160407</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>American Sales Company</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 10; 200; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-11-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160407</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these common cold and flu symptoms:. nasal congestion. headache. cough. minor aches and pains. sore throat. temporarily reduces fever. helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>46708-773-10</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (46708-773-10) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK</PackageDescription>
<NDC11Code>46708-0773-10</NDC11Code>
<ProductNDC>46708-773</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260302</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217278</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260302</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lamotrigine orally disintegrating tablets are indicated for:Epilepsy - adjunctive therapy in patients aged 2 years and older: partial-onset seizures. primary generalized tonic-clonic (PGTC) seizures. generalized seizures of Lennox-Gastaut syndrome. (1.1). Epilepsy - monotherapy in patients aged 16 years and older: Conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug. (1.1)Bipolar disorder: Maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy. (1.2) Limitations of Use: Treatment of acute manic or mixed episodes is not recommended. Effectiveness of lamotrigine orally disintegrating tablets in the acute treatment of mood episodes has not been established.</IndicationAndUsage>
<Description>Lamotrigine, USP an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine is a white or almost white powder and has a pKa of 5.7. Lamotrigine is slightly soluble in anhydrous ethanol and in 0.1M hydrochloric acid. The structural formula is. Lamotrigine orally disintegrating tablets, USP are supplied for oral administration. The tablets contain 25 mg (white to off-white), 50 mg (white to off-white), 100 mg (white to off-white), or 200 mg (white to off-white) of lamotrigine, USP and the following inactive ingredients: amino methacrylate copolymer, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, sodium stearyl fumarate and sucralose. Composition of peppermint flavor: Maltodextrin, modified corn starch and natural flavours. Lamotrigine orally disintegrating tablets are formulated using granulation technology in which the lamotrigine drug substance is granulated with amino methacrylate copolymer for taste masking. The formulation contains flavor and has a good mouth feel, no grittiness, no after taste, better palatability and gives a desired dissolution profile.</Description>
</NDC>
<NDC>
<NDCCode>55648-773-04</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (55648-773-04) > 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55648-0773-04</NDC11Code>
<ProductNDC>55648-773</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropinirole Hydrochloride</ProprietaryName>
<NonProprietaryName>Ropinirole Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120815</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091395</ApplicationNumber>
<LabelerName>Wockhardt Limited</LabelerName>
<SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ropinirole Extended-release Tablet is an orally administered, non-ergoline dopamine agonist indicated for the treatment of signs and symptoms of idiopathic Parkinson’s disease. (1.1).</IndicationAndUsage>
<Description>Ropinirole hydrochloride is an orally administered non-ergoline dopamine agonist. It is supplied as the hydrochloride salt of ropinirole 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and has an empirical formula of C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is:. Ropinirole hydrochloride is a white to cream crystalline powder solid with a melting range of 241° to 245°C and soluble in water and methanol, very slightly soluble in ethyl alcohol. Ropinirole Extended-release Tablets are formulated as film coated, circular shaped tablets with beveled edge. Ropinirole Extended-release Tablets are available in 2 mg (pink), 4 mg (light brown), 6 mg (white), 8 mg (brown) and 12 mg (green). Each tablet contains 2.28 mg, 4.56 mg, 6.84 mg, 9.12 mg, and 13.68 mg ropinirole hydrochloride equivalent to ropinirole 2 mg, 4 mg, 6 mg, 8 mg, and 12 mg, respectively. Inactive ingredients consist of carboxy methyl cellulose sodium, colloidal silicon dioxide, ethyl cellulose, hydrogenated castor oil, hydroxy propyl methyl cellulose 2910, hypromellose, magnesium stearate, maltodextrin, polyethylene glycol 400, pregelatinized starch, povidone, titanium dioxide and triethyl citrate. Ropinirole Extended-release Tablet 2 mg also contains iron oxide red and iron oxide yellow. Ropinirole Extended-release Tablet 4 mg also contains iron oxide yellow, iron oxide red and iron oxide black. Ropinirole Extended-release Tablet 8 mg also contains iron oxide red and FD&C blue # 2. Ropinirole Extended-release Tablet 12 mg also contains iron oxide yellow and FD&C blue # 2.</Description>
</NDC>
<NDC>
<NDCCode>62207-773-58</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (62207-773-58) / 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>62207-0773-58</NDC11Code>
<ProductNDC>62207-773</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ranitidine</ProprietaryName>
<NonProprietaryName>Ranitidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190626</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210243</ApplicationNumber>
<LabelerName>Granules India Ltd</LabelerName>
<SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190626</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>◾ relieves heartburn associated with acid indigestion and sour stomach ◾ prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62332-773-10</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (62332-773-10) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK</PackageDescription>
<NDC11Code>62332-0773-10</NDC11Code>
<ProductNDC>62332-773</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260302</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217278</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260302</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lamotrigine orally disintegrating tablets are indicated for:Epilepsy - adjunctive therapy in patients aged 2 years and older: partial-onset seizures. primary generalized tonic-clonic (PGTC) seizures. generalized seizures of Lennox-Gastaut syndrome. (1.1). Epilepsy - monotherapy in patients aged 16 years and older: Conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug. (1.1)Bipolar disorder: Maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy. (1.2) Limitations of Use: Treatment of acute manic or mixed episodes is not recommended. Effectiveness of lamotrigine orally disintegrating tablets in the acute treatment of mood episodes has not been established.</IndicationAndUsage>
<Description>Lamotrigine, USP an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine is a white or almost white powder and has a pKa of 5.7. Lamotrigine is slightly soluble in anhydrous ethanol and in 0.1M hydrochloric acid. The structural formula is. Lamotrigine orally disintegrating tablets, USP are supplied for oral administration. The tablets contain 25 mg (white to off-white), 50 mg (white to off-white), 100 mg (white to off-white), or 200 mg (white to off-white) of lamotrigine, USP and the following inactive ingredients: amino methacrylate copolymer, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, sodium stearyl fumarate and sucralose. Composition of peppermint flavor: Maltodextrin, modified corn starch and natural flavours. Lamotrigine orally disintegrating tablets are formulated using granulation technology in which the lamotrigine drug substance is granulated with amino methacrylate copolymer for taste masking. The formulation contains flavor and has a good mouth feel, no grittiness, no after taste, better palatability and gives a desired dissolution profile.</Description>
</NDC>
<NDC>
<NDCCode>63304-773-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (63304-773-10) </PackageDescription>
<NDC11Code>63304-0773-10</NDC11Code>
<ProductNDC>63304-773</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lorazepam</ProprietaryName>
<NonProprietaryName>Lorazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230625</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076045</ApplicationNumber>
<LabelerName>SUN PHARMACEUTICAL INDUSTRIES INC</LabelerName>
<SubstanceName>LORAZEPAM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2023-07-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230625</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lorazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Lorazepam USP, an antianxiety agent, has the chemical formula, 7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one. It is a white or practically white, crystalline powder, practically insoluble in water, sparingly soluble in Ethanol (96%), slightly soluble in Chloroform and Ether, sparingly or slightly soluble in Dichloromethane. Soluble in Acetone and glacial Acetic acid. Each lorazepam tablet, USP, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam, USP. The inactive ingredients present are lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polacrilin potassium.</Description>
</NDC>
<NDC>
<NDCCode>63868-773-10</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (63868-773-10) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>63868-0773-10</NDC11Code>
<ProductNDC>63868-773</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19880524</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075010</ApplicationNumber>
<LabelerName>CHAIN DRUG MARKETING ASSOCIATION INC</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19880524</StartMarketingDatePackage>
<EndMarketingDatePackage>20290331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to: headachethe common coldmenstrual crampsbackachetoothache muscular achesminor pain of arthritis. temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>64679-773-04</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (64679-773-04) > 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>64679-0773-04</NDC11Code>
<ProductNDC>64679-773</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropinirole Hydrochloride</ProprietaryName>
<NonProprietaryName>Ropinirole Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120815</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091395</ApplicationNumber>
<LabelerName>Wockhardt USA LLC.</LabelerName>
<SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ropinirole Extended-release Tablets are indicated for the treatment of Parkinson's disease.</IndicationAndUsage>
<Description>Ropinirole extended-release tablet contains ropinirole, a non-ergoline dopamine agonist as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the molecular formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride, USP is a white to cream crystalline powder solid with a melting range of 241° to 245°C and soluble in water and methanol, very slightly soluble in ethyl alcohol. Ropinirole extended-release tablets are formulated as film coated, circular shaped tablets with beveled edge. Each tablet contains 2.28 mg, 4.56 mg, 6.84 mg, 9.12 mg, or 13.68 mg ropinirole hydrochloride equivalent to ropinirole 2 mg (pink), 4 mg (light brown), 6 mg (white), 8 mg (brown), or 12 mg (green), respectively. Inactive ingredients consist of carboxy methyl cellulose sodium, colloidal silicon dioxide, ethyl cellulose, hydrogenated castor oil, hydroxy propyl methyl cellulose 2910, hypromellose, magnesium stearate, maltodextrin, polyethylene glycol 400, pregelatinized starch, povidone, titanium dioxide and triethyl citrate. Ropinirole extended-release tablet 2 mg also contains iron oxide red and iron oxide yellow. Ropinirole extended-release tablet 4 mg also contains iron oxide yellow, iron oxide red and iron oxide black. Ropinirole extended-release tablet 8 mg also contains iron oxide red and FD&C blue # 2. Ropinirole extended-release tablet 12 mg also contains iron oxide yellow and FD&C blue # 2.</Description>
</NDC>
<NDC>
<NDCCode>65841-773-77</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (65841-773-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65841-773-30) </PackageDescription>
<NDC11Code>65841-0773-77</NDC11Code>
<ProductNDC>65841-773</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sirolimus</ProprietaryName>
<NonProprietaryName>Sirolimus</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201676</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>SIROLIMUS</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>66733-773-01</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (66733-773-01) > 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>66733-0773-01</NDC11Code>
<ProductNDC>66733-773</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Insulin Lispro</ProprietaryName>
<NonProprietaryName>Insulin Lispro</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190304</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA020563</ApplicationNumber>
<LabelerName>ImClone LLC</LabelerName>
<SubstanceName>INSULIN LISPRO</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190319</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68382-773-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (68382-773-10) </PackageDescription>
<NDC11Code>68382-0773-10</NDC11Code>
<ProductNDC>68382-773</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ezetimibe</ProprietaryName>
<NonProprietaryName>Ezetimibe</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170809</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204331</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>EZETIMIBE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170809</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ezetimibe tablets are indicated: 1 In combination with a statin, or alone when additional low-density lipoprotein cholesterol (LDL-C) lowering therapy is not possible, as an adjunct to diet to reduce elevated LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH). , 2 In combination with a statin as an adjunct to diet to reduce elevated LDL-C in pediatric patients 10 years of age and older with HeFH. , 3 In combination with fenofibrate as an adjunct to diet to reduce elevated LDL-C in adults with mixed hyperlipidemia. , 4 In combination with a statin, and other LDL-C lowering therapies, to reduce elevated LDL-C levels in adults and in pediatric patients 10 years of age and older with homozygous familial hypercholesterolemia (HoFH). , 5 As an adjunct to diet for the reduction of elevated sitosterol and campesterol levels in adults and in pediatric patients 9 years of age and older with homozygous familial sitosterolemia. .</IndicationAndUsage>
<Description>Ezetimibe is a dietary cholesterol absorption inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3. Its molecular weight is 409.4 and its structural formula is. Ezetimibe, USP is a white to an off-white crystalline powder. It is freely soluble in methanol and acetone, soluble in ethanol and practically insoluble in water. Ezetimibe has a melting point of about 163°C and is stable at ambient temperature. Each ezetimibe tablet, USP available for oral administration contains 10 mg of ezetimibe. In addition, each tablet contains the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (botanical source: maize), sodium lauryl sulfate and sodium stearyl fumarate.</Description>
</NDC>
<NDC>
<NDCCode>68382-773-77</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (68382-773-77) / 10 TABLET in 1 BLISTER PACK (68382-773-30) </PackageDescription>
<NDC11Code>68382-0773-77</NDC11Code>
<ProductNDC>68382-773</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ezetimibe</ProprietaryName>
<NonProprietaryName>Ezetimibe</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170809</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204331</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>EZETIMIBE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170809</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ezetimibe tablets are indicated: 1 In combination with a statin, or alone when additional low-density lipoprotein cholesterol (LDL-C) lowering therapy is not possible, as an adjunct to diet to reduce elevated LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH). , 2 In combination with a statin as an adjunct to diet to reduce elevated LDL-C in pediatric patients 10 years of age and older with HeFH. , 3 In combination with fenofibrate as an adjunct to diet to reduce elevated LDL-C in adults with mixed hyperlipidemia. , 4 In combination with a statin, and other LDL-C lowering therapies, to reduce elevated LDL-C levels in adults and in pediatric patients 10 years of age and older with homozygous familial hypercholesterolemia (HoFH). , 5 As an adjunct to diet for the reduction of elevated sitosterol and campesterol levels in adults and in pediatric patients 9 years of age and older with homozygous familial sitosterolemia. .</IndicationAndUsage>
<Description>Ezetimibe is a dietary cholesterol absorption inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3. Its molecular weight is 409.4 and its structural formula is. Ezetimibe, USP is a white to an off-white crystalline powder. It is freely soluble in methanol and acetone, soluble in ethanol and practically insoluble in water. Ezetimibe has a melting point of about 163°C and is stable at ambient temperature. Each ezetimibe tablet, USP available for oral administration contains 10 mg of ezetimibe. In addition, each tablet contains the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (botanical source: maize), sodium lauryl sulfate and sodium stearyl fumarate.</Description>
</NDC>
<NDC>
<NDCCode>70069-773-10</NDCCode>
<PackageDescription>10 VIAL, GLASS in 1 CARTON (70069-773-10) / 10 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>70069-0773-10</NDC11Code>
<ProductNDC>70069-773</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Calcium Chloride Dihydrate</ProprietaryName>
<NonProprietaryName>Calcium Chloride Dihydrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20241219</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218133</ApplicationNumber>
<LabelerName>Somerset Therapeutics, LLC</LabelerName>
<SubstanceName>CALCIUM CHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Calcium chloride injection is indicated for the treatment of adult and pediatric patients with acute symptomatic hypocalcemia. Limitations of Use. The safety and effectiveness of calcium chloride injection for long-term use has not been established.</IndicationAndUsage>
<Description>10% Calcium chloride injection, USP is a sterile, nonpyrogenic, hypertonic solution for single administration only. Each mL contains 100 mg (1.4 mEq/mL) of calcium chloride, dihydrate (1.4 mEq each of Ca++ and Cl-) in water for injection. It is provided in a 10 mL single-dose vial for intravenous injection. The solution contains no bacteriostat, antimicrobial agent or added buffer. The pH of 10% calcium chloride injection, USP is 5.5 to 7.5 when diluted with water for injection to make a 5% solution. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. The osmolar concentration is 2.04 mOsmol/mL (calc.). 10% calcium chloride injection, USP is oxygen sensitive. Calcium chloride, USP dihydrate is chemically designated CaCl2 2H2O (dihydrate) and is described as white, odorless fragments or granules freely soluble in water. Calcium chloride injection, USP contains no more than 1,000 mcg/L of aluminum [see Warnings and Precautions (5.2)].</Description>
</NDC>
<NDC>
<NDCCode>70954-773-20</NDCCode>
<PackageDescription>28 BLISTER PACK in 1 CARTON (70954-773-20) / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (70954-773-10) </PackageDescription>
<NDC11Code>70954-0773-20</NDC11Code>
<ProductNDC>70954-773</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Everolimus</ProprietaryName>
<NonProprietaryName>Everolimus</NonProprietaryName>
<DosageFormName>TABLET, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251010</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA220597</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>EVEROLIMUS</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251010</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Everolimus tablets for oral suspension is a kinase inhibitor indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected (1.5). Everolimus tablets for oral suspension is a kinase inhibitor indicated for the adjunctive treatment of adult and pediatric patients aged 2 years and older with TSC-associated partial-onset seizures. (1.6).</IndicationAndUsage>
<Description>Everolimus tablets for oral suspension are a kinase inhibitors. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18-dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.2 g/mol. The structural formula is. Everolimus tablets for oral suspension for oral administration contains 2 mg, 3 mg, or 5 mg of everolimus and the following inactive ingredients: butylhydroxytoluene, colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, mannitol, and microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>82182-773-10</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (82182-773-10) / 10 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>82182-0773-10</NDC11Code>
<ProductNDC>82182-773</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Brimonidine Tartrate</ProprietaryName>
<NonProprietaryName>Brimonidine Tartrate</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20220228</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021262</ApplicationNumber>
<LabelerName>Pacific Pharma, Inc.</LabelerName>
<SubstanceName>BRIMONIDINE TARTRATE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>82907-773-10</NDCCode>
<PackageDescription>10 g in 1 BOTTLE (82907-773-10) </PackageDescription>
<NDC11Code>82907-0773-10</NDC11Code>
<ProductNDC>82907-773</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Elamipretide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20230908</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Hangzhou Sinodo Pharm Technology Co.,Ltd</LabelerName>
<SubstanceName>ELAMIPRETIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>08-SEP-23</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>23155-001-10</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (23155-001-10) </PackageDescription>
<NDC11Code>23155-0001-10</NDC11Code>
<ProductNDC>23155-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydralazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070406</StartMarketingDate>
<EndMarketingDate>20260831</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA086242</ApplicationNumber>
<LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
<SubstanceName>HYDRALAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20070406</StartMarketingDatePackage>
<EndMarketingDatePackage>20260831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Essential hypertension, alone or as an adjunct.</IndicationAndUsage>
<Description>HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose, lactose anhydrous, light mineral oil, microcrystalline cellulose, magnesium stearate, pregelatinized starch, sodium lauryl sulfate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>23155-002-10</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (23155-002-10) </PackageDescription>
<NDC11Code>23155-0002-10</NDC11Code>
<ProductNDC>23155-002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydralazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070406</StartMarketingDate>
<EndMarketingDate>20260831</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA086242</ApplicationNumber>
<LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
<SubstanceName>HYDRALAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20070406</StartMarketingDatePackage>
<EndMarketingDatePackage>20260831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Essential hypertension, alone or as an adjunct.</IndicationAndUsage>
<Description>HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose, lactose anhydrous, light mineral oil, microcrystalline cellulose, magnesium stearate, pregelatinized starch, sodium lauryl sulfate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>23155-003-10</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (23155-003-10) </PackageDescription>
<NDC11Code>23155-0003-10</NDC11Code>
<ProductNDC>23155-003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydralazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070406</StartMarketingDate>
<EndMarketingDate>20260930</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA086242</ApplicationNumber>
<LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
<SubstanceName>HYDRALAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20070406</StartMarketingDatePackage>
<EndMarketingDatePackage>20260930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Essential hypertension, alone or as an adjunct.</IndicationAndUsage>
<Description>HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose, lactose anhydrous, light mineral oil, microcrystalline cellulose, magnesium stearate, pregelatinized starch, sodium lauryl sulfate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>23155-004-10</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (23155-004-10) </PackageDescription>
<NDC11Code>23155-0004-10</NDC11Code>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydralazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20070406</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA086242</ApplicationNumber>
<LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
<SubstanceName>HYDRALAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-13</LastUpdate>
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<IndicationAndUsage>Essential hypertension, alone or as an adjunct.</IndicationAndUsage>
<Description>HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose, lactose anhydrous, light mineral oil, microcrystalline cellulose, magnesium stearate, pregelatinized starch, sodium lauryl sulfate, and titanium dioxide.</Description>
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<NDCCode>23155-008-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (23155-008-10) </PackageDescription>
<NDC11Code>23155-0008-10</NDC11Code>
<ProductNDC>23155-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085182</ApplicationNumber>
<LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
<SubstanceName>HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-03</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide tablets are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension. Use in Pregnancy. Routine use of diuretics during normal pregnancy is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of toxemia. Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Thiazides are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy (see PRECAUTIONS, Pregnancy). Dependent edema in pregnancy, resulting from restriction of venous return by the gravid uterus, is properly treated through elevation of the lower extremities and use of support stockings. Use of diuretics to lower intravascular volume in this instance is illogical and unnecessary. During normal pregnancy there is hypervolemia which is not harmful to the fetus or the mother in the absence of cardiovascular disease. However, it may be associated with edema, rarely generalized edema. If such edema causes discomfort, increased recumbency will often provide relief. Rarely this edema may cause extreme discomfort which is not relieved by rest. In these instances, a short course of diuretic therapy may provide relief and be appropriate.</IndicationAndUsage>
<Description>Hydrochlorothiazide is a diuretic and antihypertensive. It is the 3,4-dihydro derivative of chlorothiazide. Its chemical name is 6-chloro-3,4-dihydro-2 H -1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its molecular formula is C7H8CIN3O4S2 and its structural formula is. It is a white, or practically white, crystalline powder with a molecular weight of 297.74 which is slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform and in dilute mineral acids. Each tablet for oral administration contains 12.5 mg, 25 mg or 50 mg of hydrochlorothiazide respectively. In addition, each tablet contains following inactive ingredients: anhydrous lactose, D&C Yellow No.10 aluminum lake, FD&C Red No. 40 aluminum lake, magnesium stearate, pregelatinized starch and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>23155-009-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (23155-009-10) </PackageDescription>
<NDC11Code>23155-0009-10</NDC11Code>
<ProductNDC>23155-009</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085182</ApplicationNumber>
<LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
<SubstanceName>HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide tablets are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension. Use in Pregnancy. Routine use of diuretics during normal pregnancy is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of toxemia. Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Thiazides are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy (see PRECAUTIONS, Pregnancy). Dependent edema in pregnancy, resulting from restriction of venous return by the gravid uterus, is properly treated through elevation of the lower extremities and use of support stockings. Use of diuretics to lower intravascular volume in this instance is illogical and unnecessary. During normal pregnancy there is hypervolemia which is not harmful to the fetus or the mother in the absence of cardiovascular disease. However, it may be associated with edema, rarely generalized edema. If such edema causes discomfort, increased recumbency will often provide relief. Rarely this edema may cause extreme discomfort which is not relieved by rest. In these instances, a short course of diuretic therapy may provide relief and be appropriate.</IndicationAndUsage>
<Description>Hydrochlorothiazide is a diuretic and antihypertensive. It is the 3,4-dihydro derivative of chlorothiazide. Its chemical name is 6-chloro-3,4-dihydro-2 H -1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its molecular formula is C7H8CIN3O4S2 and its structural formula is. It is a white, or practically white, crystalline powder with a molecular weight of 297.74 which is slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform and in dilute mineral acids. Each tablet for oral administration contains 12.5 mg, 25 mg or 50 mg of hydrochlorothiazide respectively. In addition, each tablet contains following inactive ingredients: anhydrous lactose, D&C Yellow No.10 aluminum lake, FD&C Red No. 40 aluminum lake, magnesium stearate, pregelatinized starch and sodium starch glycolate.</Description>
</NDC>
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<NDCCode>23155-010-10</NDCCode>
<PackageDescription>1000 CAPSULE in 1 BOTTLE, PLASTIC (23155-010-10)</PackageDescription>
<NDC11Code>23155-0010-10</NDC11Code>
<ProductNDC>23155-010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Indomethacin</ProprietaryName>
<NonProprietaryName>Indomethacin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100710</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018851</ApplicationNumber>
<LabelerName>Heritage Pharmaceuticals Inc.</LabelerName>
<SubstanceName>INDOMETHACIN</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-08-25</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
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<NDCCode>23155-017-10</NDCCode>
<PackageDescription>1000 CAPSULE in 1 BOTTLE (23155-017-10) </PackageDescription>
<NDC11Code>23155-0017-10</NDC11Code>
<ProductNDC>23155-017</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tetracycline Hydrochloride</ProprietaryName>
<NonProprietaryName>Tetracycline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131018</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050278</ApplicationNumber>
<LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
<SubstanceName>TETRACYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-12-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131018</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDCCode>23155-018-10</NDCCode>
<PackageDescription>1000 CAPSULE in 1 BOTTLE (23155-018-10) </PackageDescription>
<NDC11Code>23155-0018-10</NDC11Code>
<ProductNDC>23155-018</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tetracycline Hydrochloride</ProprietaryName>
<NonProprietaryName>Tetracycline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131018</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050278</ApplicationNumber>
<LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
<SubstanceName>TETRACYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-12-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131018</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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