{
"NDC": [
{
"NDCCode": "71610-354-11",
"PackageDescription": "48 TABLET, FILM COATED in 1 BOTTLE (71610-354-11) ",
"NDC11Code": "71610-0354-11",
"ProductNDC": "71610-354",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tadalafil",
"NonProprietaryName": "Tadalafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20181009",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090141",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "TADALAFIL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20191025",
"SamplePackage": "N",
"IndicationAndUsage": "Tadalafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: 1 erectile dysfunction (ED) ( 1.1) , 2 the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2) , 3 ED and the signs and symptoms of BPH (ED/BPH) ( 1.3) .",
"Description": "Tadalafil, USP is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). The structural formula is. C 22H 19N 3O 4 M.W. 389.41. The chemical designation is (6R,12aR)-2,3,6,7,12,12a-hexahydro-2-methyl-6-(3,4-methylenedioxyphenyl)-pyrazino-[2',1':6,1]pyrido[3,4-b]indole-1,4-dione. It is a white to off-white crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil, USP is available as round or oval-shaped, film-coated tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil, USP and the following inactive ingredients: croscarmellose sodium, iron oxide yellow, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol – part. hydrolyzed, povidone, sodium lauryl sulfate, sodium starch glycolate, sodium stearyl fumarate, talc, and titanium dioxide."
},
{
"NDCCode": "71610-354-23",
"PackageDescription": "16 TABLET, FILM COATED in 1 BOTTLE (71610-354-23) ",
"NDC11Code": "71610-0354-23",
"ProductNDC": "71610-354",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tadalafil",
"NonProprietaryName": "Tadalafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20181009",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090141",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "TADALAFIL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20191025",
"SamplePackage": "N",
"IndicationAndUsage": "Tadalafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: 1 erectile dysfunction (ED) ( 1.1) , 2 the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2) , 3 ED and the signs and symptoms of BPH (ED/BPH) ( 1.3) .",
"Description": "Tadalafil, USP is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). The structural formula is. C 22H 19N 3O 4 M.W. 389.41. The chemical designation is (6R,12aR)-2,3,6,7,12,12a-hexahydro-2-methyl-6-(3,4-methylenedioxyphenyl)-pyrazino-[2',1':6,1]pyrido[3,4-b]indole-1,4-dione. It is a white to off-white crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil, USP is available as round or oval-shaped, film-coated tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil, USP and the following inactive ingredients: croscarmellose sodium, iron oxide yellow, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol – part. hydrolyzed, povidone, sodium lauryl sulfate, sodium starch glycolate, sodium stearyl fumarate, talc, and titanium dioxide."
},
{
"NDCCode": "71610-354-47",
"PackageDescription": "24 TABLET, FILM COATED in 1 BOTTLE (71610-354-47) ",
"NDC11Code": "71610-0354-47",
"ProductNDC": "71610-354",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tadalafil",
"NonProprietaryName": "Tadalafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20181009",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090141",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "TADALAFIL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20191025",
"SamplePackage": "N",
"IndicationAndUsage": "Tadalafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: 1 erectile dysfunction (ED) ( 1.1) , 2 the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2) , 3 ED and the signs and symptoms of BPH (ED/BPH) ( 1.3) .",
"Description": "Tadalafil, USP is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). The structural formula is. C 22H 19N 3O 4 M.W. 389.41. The chemical designation is (6R,12aR)-2,3,6,7,12,12a-hexahydro-2-methyl-6-(3,4-methylenedioxyphenyl)-pyrazino-[2',1':6,1]pyrido[3,4-b]indole-1,4-dione. It is a white to off-white crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil, USP is available as round or oval-shaped, film-coated tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil, USP and the following inactive ingredients: croscarmellose sodium, iron oxide yellow, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol – part. hydrolyzed, povidone, sodium lauryl sulfate, sodium starch glycolate, sodium stearyl fumarate, talc, and titanium dioxide."
},
{
"NDCCode": "43547-354-11",
"PackageDescription": "1000 TABLET in 1 BOTTLE (43547-354-11) ",
"NDC11Code": "43547-0354-11",
"ProductNDC": "43547-354",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril",
"NonProprietaryName": "Lisinopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20111101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076164",
"LabelerName": "Solco healthcare U.S., LLC",
"SubstanceName": "LISINOPRIL",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20111101",
"SamplePackage": "N",
"IndicationAndUsage": "Lisinopril is an angiotensin converting enzyme (ACE) inhibitor indicated for: 1 Treatment of hypertension in adults and pediatric patients 6 years of age and older (1.1), 2 Adjunct therapy for heart failure (1.2), 3 Treatment of Acute Myocardial Infarction (1.3).",
"Description": "Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril tablets, USP, are supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients. 2.5 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, sodium starch glycolate and magnesium stearate. 5 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate and yellow ferric oxide. 10 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate and red ferric oxide. 20 and 30 mg tablets - Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, magnesium stearate and red ferric oxide. 40 mg tablets - Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, magnesium stearate and yellow ferric oxide. *: Pregelatinized starch is a physically modified corn (maize) starch."
},
{
"NDCCode": "49884-354-11",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (49884-354-11) ",
"NDC11Code": "49884-0354-11",
"ProductNDC": "49884-354",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ambrisentan",
"NonProprietaryName": "Ambrisentan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190416",
"EndMarketingDate": "20221231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209509",
"LabelerName": "Par Pharmaceutical, Inc.",
"SubstanceName": "AMBRISENTAN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190416",
"EndMarketingDatePackage": "20221231",
"SamplePackage": "N"
},
{
"NDCCode": "60687-354-01",
"PackageDescription": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-354-01) > 1 CAPSULE in 1 BLISTER PACK (60687-354-11) ",
"NDC11Code": "60687-0354-01",
"ProductNDC": "60687-354",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ramipril",
"NonProprietaryName": "Ramipril",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170907",
"EndMarketingDate": "20210531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078832",
"LabelerName": "American Health Packaging",
"SubstanceName": "RAMIPRIL",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170907",
"EndMarketingDatePackage": "20210531",
"SamplePackage": "N"
},
{
"NDCCode": "68084-354-01",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (68084-354-01) / 1 TABLET in 1 BLISTER PACK (68084-354-11) ",
"NDC11Code": "68084-0354-01",
"ProductNDC": "68084-354",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091204",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091393",
"LabelerName": "American Health Packaging",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20091204",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone hydrochloride is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration even at recommended doses [seeWarnings and Precautions (5.1)], reserve oxycodone hydrochloride for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products):. Have not been tolerated or are not expected to be tolerated. Have not provided adequate analgesia or are not expected to provide adequate analgesia. Oxycodone hydrochloride should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.",
"Description": "Oxycodone hydrochloride tablets, USP contains oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg, or 30 mg, of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. Oxycodone hydrochloride tablets, USP contains inactive ingredients: corn starch; lactose monohydrate; microcrystalline cellulose; silicon dioxide; sodium starch glycolate; and magnesium stearate. The 10 mg tablet also contains D&C Red No. 27 aluminum lake. The 15 mg tablet also contains D&C Yellow No. 10 aluminum lake and FD&C Blue No. 2 aluminum lake. The 20 mg tablet also contains FD&C Blue No. 2 aluminum lake; FD&C Red No. 40 aluminum lake; and FD&C Yellow No. 6 aluminum lake. The 30 mg tablet also contains FD&C Blue No. 2 aluminum lake. The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.5 mg, 9 mg, 13.5 mg 18 mg and 27 mg, respectively, of oxycodone free base."
},
{
"NDCCode": "68428-354-11",
"PackageDescription": "300 PELLET in 1 BOTTLE, GLASS (68428-354-11) ",
"NDC11Code": "68428-0354-11",
"ProductNDC": "68428-354",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cypripedium Pubescens",
"NonProprietaryName": "Cypripedium Parvifolum Root",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100203",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2022-04-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20100203",
"SamplePackage": "N"
},
{
"NDCCode": "80714-034-11",
"PackageDescription": "6 BOTTLE, PUMP in 1 CARTON (80714-034-11) / 354 mL in 1 BOTTLE, PUMP (80714-034-10) ",
"NDC11Code": "80714-0034-11",
"ProductNDC": "80714-034",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Clorox Hand Sanitizer Gel",
"NonProprietaryName": "Alcohol Hand Sanitizer",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201030",
"EndMarketingDate": "20250131",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "New Wave Global Services Inc",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2024-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20201030",
"EndMarketingDatePackage": "20240331",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria on the skin."
},
{
"NDCCode": "71610-214-11",
"PackageDescription": "48 TABLET, FILM COATED in 1 BOTTLE (71610-214-11) ",
"NDC11Code": "71610-0214-11",
"ProductNDC": "71610-214",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tadalafil",
"NonProprietaryName": "Tadalafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180927",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021368",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "TADALAFIL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-06-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20181228",
"SamplePackage": "N",
"IndicationAndUsage": "Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: : 1 erectile dysfunction (ED) (1.1) , 2 the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2) , 3 ED and the signs and symptoms of BPH (ED/BPH) (1.3) .",
"Description": "Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is:. The chemical designation is pyrazino[1´,2´:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil is available as almond-shaped tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, and triacetin."
},
{
"NDCCode": "71610-273-62",
"PackageDescription": "11 TABLET, FILM COATED in 1 BOTTLE (71610-273-62) ",
"NDC11Code": "71610-0273-62",
"ProductNDC": "71610-273",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zolpidem Tartrate",
"NonProprietaryName": "Zolpidem Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190221",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076410",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "ZOLPIDEM TARTRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Depression [PE], GABA A Agonists [MoA], Pyridines [CS], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N",
"IndicationAndUsage": "Zolpidem tartrate tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies (14)]. The clinical trials performed in support of efficacy were 4 to 5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.",
"Description": "Zolpidem tartrate, USP is a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class and is available in 5 mg and 10 mg strength tablets for oral administration. Chemically, zolpidem tartrate, USP is N, N,6-Trimethyl-2- p-tolylimidazo[1,2-α]pyridine-3-acetamide L-(+)-tartrate. It has the following structure:. (C 19H 21N 3O) 2C 4H 6O 6 M.W. 764.87. Zolpidem tartrate, USP is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. Each zolpidem Tartrate Tablet USP includes the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide; the 5 mg tablet also contains iron oxide red."
},
{
"NDCCode": "71610-298-11",
"PackageDescription": "48 TABLET, FILM COATED in 1 BOTTLE (71610-298-11) ",
"NDC11Code": "71610-0298-11",
"ProductNDC": "71610-298",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tadalafil",
"NonProprietaryName": "Tadalafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190326",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209908",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "TADALAFIL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190701",
"SamplePackage": "N",
"IndicationAndUsage": "Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: erectile dysfunction (ED) (1.1) the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2) ED and the signs and symptoms of BPH (ED/BPH) (1.3) If tadalafil tablet is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks (1.4).",
"Description": "Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the molecular formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is:. The chemical designation is pyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione,6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-(6R-12aR)-. Tadalafil USP is a white or almost white powder that is freely soluble in dimethyl sulfoxide, slightly soluble in methylene chloride and practically insoluble in water. Tadalafil tablets, USP are available as round (2.5 mg and 5 mg) and capsule (10 mg and 20 mg) shaped tablets for oral administration. Each tablet contains 2.5 mg, 5 mg, 10 mg, or 20 mg of tadalafil USP and the following inactive ingredients: colloidal silicon dioxide, copovidone, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyoxyl 40 hydrogenated castor oil, talc, titanium dioxide and triacetin. In addition, 2.5 mg contains FD&C blue #2/indigo carmine aluminum lake. USP dissolution test is pending."
},
{
"NDCCode": "71610-324-11",
"PackageDescription": "48 TABLET, FILM COATED in 1 BOTTLE (71610-324-11) ",
"NDC11Code": "71610-0324-11",
"ProductNDC": "71610-324",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tadalafil",
"NonProprietaryName": "Tadalafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190326",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208934",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "TADALAFIL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190813",
"SamplePackage": "N",
"IndicationAndUsage": "Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: 1 erectile dysfunction (ED) (1.1), 2 the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2), 3 ED and the signs and symptoms of BPH (ED/BPH) (1.3).",
"Description": "Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the molecular formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is. The chemical designation is pyrazino[1’,2’:1,6]pyrido[3,4-b]indole-1,4-dione,6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-,(6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil tablets, USP are available as round shaped (2.5 mg) and oval shaped (5 mg, 10 mg, and 20 mg) tablets for oral administration. Each tadalafil tablet, USP contains 2.5 mg, 5 mg, 10 mg, or 20 mg of tadalafil, USP and the following inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer, polyethylene glycol, talc, titanium dioxide, and yellow iron oxide."
},
{
"NDCCode": "71610-448-11",
"PackageDescription": "48 TABLET in 1 BOTTLE (71610-448-11) ",
"NDC11Code": "71610-0448-11",
"ProductNDC": "71610-448",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Warfarin Sodium",
"NonProprietaryName": "Warfarin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110525",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090935",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "WARFARIN SODIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2020-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200730",
"SamplePackage": "N",
"IndicationAndUsage": "Warfarin sodium tablets, are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.",
"Description": "Warfarin sodium, USP is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. The chemical name of warfarin sodium is 3-(α- acetonylbenzyl)-4-hydroxycoumarin sodium salt, which is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its empirical formula is C 19H 15NaO 4, and its structural formula is represented by the following:. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet, USP intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinized starch, hydroxypropyl cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red #30 aluminum lake. 2 mg tablet contains: FD&C Red #40 aluminum lake and FD&C Blue#2. 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue #2. 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue#2 and FD&C Red # 40 aluminum lake. 4 mg tablet contains: FD&C Blue#2. 5 mg tablet contains: FD&C Yellow # 6 aluminum lake. 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue #2. 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake. 10 mg tablet is dye free."
},
{
"NDCCode": "71610-461-11",
"PackageDescription": "48 TABLET in 1 BOTTLE (71610-461-11) ",
"NDC11Code": "71610-0461-11",
"ProductNDC": "71610-461",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tadalafil",
"NonProprietaryName": "Tadalafil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190326",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209654",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "TADALAFIL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2020-10-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200904",
"SamplePackage": "N",
"IndicationAndUsage": "Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: : 1 erectile dysfunction (ED) (1.1) , 2 the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2) , 3 ED and the signs and symptoms of BPH (ED/BPH) (1.3).",
"Description": "Tadalafil, USP is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the molecular formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is:. The chemical designation is pyrazino[1′,2′:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is white to almost white powder that is practically insoluble in water, freely soluble in dimethyl sulfoxide and slightly soluble in methylene chloride. Tadalafil Tablets, USP are available as light yellow to yellow coloured oval shaped film coated tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, sodium lauryl sulphate, low-substituted hydroxypropyl cellulose and magnesium stearate. The color coating contains hypromellose, titanium dioxide, lactose monohydrate, iron oxide yellow, triacetin and FD&C yellow #5/tartrazine aluminium lake."
},
{
"NDCCode": "71610-603-11",
"PackageDescription": "48 TABLET, FILM COATED in 1 BOTTLE (71610-603-11) ",
"NDC11Code": "71610-0603-11",
"ProductNDC": "71610-603",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tadalafil",
"NonProprietaryName": "Tadalafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210121",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209744",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "TADALAFIL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-03-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211018",
"SamplePackage": "N",
"IndicationAndUsage": "Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: 1 erectile dysfunction (ED) ( 1.1). , 2 the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2)., 3 ED and the signs and symptoms of BPH (ED/BPH) (1.3).",
"Description": "Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the molecular formula C 22H 19N 3O 4representing a molecular weight of 389.40. The structural formula is:. The chemical designation is pyrazino[1′,2′:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water, freely soluble in dimethyl sulfoxide, slightly soluble in methylene chloride. Tadalafil tablets USP, 2.5 mg, 5 mg, 10 mg and 20 mg are available for oral administration. Each tablet contains 2.5 mg, 5 mg, 10 mg, or 20 mg of tadalafil, USP and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide red (10 mg), iron oxide yellow (5 mg, 10 mg, 20 mg), lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide and triacetin."
},
{
"NDCCode": "71610-915-62",
"PackageDescription": "11 TABLET, FILM COATED in 1 BOTTLE (71610-915-62) ",
"NDC11Code": "71610-0915-62",
"ProductNDC": "71610-915",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zolpidem Tartrate",
"NonProprietaryName": "Zolpidem Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070423",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077214",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "ZOLPIDEM TARTRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250623",
"SamplePackage": "N",
"IndicationAndUsage": "Zolpidem Tartrate Tablets is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem Tartrate Tablets has been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies ( 14)]. The clinical trials performed in support of efficacy were 4–5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.",
"Description": "Zolpidem Tartrate Tablets, USP contains Zolpidem tartrate, a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class. Zolpidem Tartrate Tablets, USP is available in 5 mg and 10 mg strength tablets for oral administration. Chemically, Zolpidem is N, N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure. Zolpidem Tartrate is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88. Each Zolpidem Tartrate Tablet, USP includes the following inactive ingredients: lactose anhydrous, sodium starch glycolate, colloidal silicon dioxide, microcrystalline cellulose, magnesium stearate. The 10 mg tablets also contain Opadry II (white) and the 5 mg tablets contain Opadry II (pink). Opadry II (white) contains hypromellose, polyeth ylene glycol, polydextrose, titanium dioxide, and triacetin. Opadry II (pink) contains hypromellose, FD&C Red no. 40 aluminum lake, FD&C Blue no. 2 aluminum lake, FD&C Yellow no. 6 aluminum lake, polyeth ylene glycol, polydextrose, titanium dioxide, and triacetin. Meets USP Dissolution Test 3."
},
{
"NDCCode": "0009-0215-05",
"PackageDescription": "5 AMPULE in 1 PACKAGE (0009-0215-05) / 1 mL in 1 AMPULE (0009-0215-01) ",
"NDC11Code": "00009-0215-05",
"ProductNDC": "0009-0215",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prostin",
"ProprietaryNameSuffix": "Vr Pediatric",
"NonProprietaryName": "Alprostadil",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVASCULAR; INTRAVENOUS",
"StartMarketingDate": "20221003",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018484",
"LabelerName": "Pharmacia & Upjohn Company LLC",
"SubstanceName": "ALPROSTADIL",
"StrengthNumber": "500",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Genitourinary Arterial Vasodilation [PE], Prostaglandin Analog [EPC], Prostaglandin E1 Agonist [EPC], Prostaglandin Receptor Agonists [MoA], Prostaglandins [CS], Venous Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2026-08-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221003",
"SamplePackage": "N",
"IndicationAndUsage": "PROSTIN VR PEDIATRIC Sterile Solution is indicated for palliative, not definitive, therapy to temporarily maintain the patency of the ductus arteriosus until corrective or palliative surgery can be performed in neonates who have congenital heart defects and who depend upon the patent ductus for survival. Such congenital heart defects include pulmonary atresia, pulmonary stenosis, tricuspid atresia, tetralogy of Fallot, interruption of the aortic arch, coarctation of the aorta, or transposition of the great vessels with or without other defects. In infants with restricted pulmonary blood flow, the increase in blood oxygenation is inversely proportional to pretreatment pO2 values; that is, patients with low pO2 values respond best, and patients with pO2 values of 40 torr or more usually have little response. PROSTIN VR PEDIATRIC should be administered only by trained personnel in facilities that provide pediatric intensive care.",
"Description": "PROSTIN VR PEDIATRIC Sterile Solution for intravascular infusion contains 500 micrograms alprostadil, more commonly known as prostaglandin E1, in 1.0 mL dehydrated alcohol. The chemical name for alprostadil is (11α,13E,15S)-11,15 dihydroxy-9-oxo-prost-13-en-1-oic acid, and the molecular weight is 354.49. Alprostadil is a white to off-white crystalline powder with a melting point between 110° and 116°C. Its solubility at 35°C is 8000 micrograms per 100 mL double distilled water. Structural Formula."
},
{
"NDCCode": "0009-3169-06",
"PackageDescription": "5 AMPULE in 1 PACKAGE (0009-3169-06) / 1 mL in 1 AMPULE (0009-3169-01) ",
"NDC11Code": "00009-3169-06",
"ProductNDC": "0009-3169",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prostin",
"ProprietaryNameSuffix": "Vr Pediatric",
"NonProprietaryName": "Alprostadil",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVASCULAR; INTRAVENOUS",
"StartMarketingDate": "19811016",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018484",
"LabelerName": "Pharmacia & Upjohn Company LLC",
"SubstanceName": "ALPROSTADIL",
"StrengthNumber": "500",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Genitourinary Arterial Vasodilation [PE], Prostaglandin Analog [EPC], Prostaglandin E1 Agonist [EPC], Prostaglandin Receptor Agonists [MoA], Prostaglandins [CS], Venous Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2026-08-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19811016",
"SamplePackage": "N",
"IndicationAndUsage": "PROSTIN VR PEDIATRIC Sterile Solution is indicated for palliative, not definitive, therapy to temporarily maintain the patency of the ductus arteriosus until corrective or palliative surgery can be performed in neonates who have congenital heart defects and who depend upon the patent ductus for survival. Such congenital heart defects include pulmonary atresia, pulmonary stenosis, tricuspid atresia, tetralogy of Fallot, interruption of the aortic arch, coarctation of the aorta, or transposition of the great vessels with or without other defects. In infants with restricted pulmonary blood flow, the increase in blood oxygenation is inversely proportional to pretreatment pO2 values; that is, patients with low pO2 values respond best, and patients with pO2 values of 40 torr or more usually have little response. PROSTIN VR PEDIATRIC should be administered only by trained personnel in facilities that provide pediatric intensive care.",
"Description": "PROSTIN VR PEDIATRIC Sterile Solution for intravascular infusion contains 500 micrograms alprostadil, more commonly known as prostaglandin E1, in 1.0 mL dehydrated alcohol. The chemical name for alprostadil is (11α,13E,15S)-11,15 dihydroxy-9-oxo-prost-13-en-1-oic acid, and the molecular weight is 354.49. Alprostadil is a white to off-white crystalline powder with a melting point between 110° and 116°C. Its solubility at 35°C is 8000 micrograms per 100 mL double distilled water. Structural Formula."
},
{
"NDCCode": "0009-3701-05",
"PackageDescription": "6 VIAL, SINGLE-DOSE in 1 PACKAGE (0009-3701-05) / 1 mL in 1 VIAL, SINGLE-DOSE (0009-3701-08) ",
"NDC11Code": "00009-3701-05",
"ProductNDC": "0009-3701",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Caverject",
"NonProprietaryName": "Alprostadil",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRACAVERNOUS",
"StartMarketingDate": "19950706",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020379",
"LabelerName": "Pharmacia & Upjohn Company LLC",
"SubstanceName": "ALPROSTADIL",
"StrengthNumber": "20.5",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Genitourinary Arterial Vasodilation [PE], Prostaglandin Analog [EPC], Prostaglandin E1 Agonist [EPC], Prostaglandin Receptor Agonists [MoA], Prostaglandins [CS], Venous Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2024-05-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19950706",
"SamplePackage": "N",
"IndicationAndUsage": "CAVERJECT is a prostaglandin E1 agonist indicated: 1 For the treatment of erectile dysfunction (1.1). , 2 As an adjunct to other diagnostic tests in the diagnosis of erectile dysfunction (1.2).",
"Description": "CAVERJECT contains alprostadil, a synthetic form of prostaglandin E1 (PGE1), and is designated chemically as (11α,13E,15S)-11,15-dihydroxy-9-oxoprost-13-en-1-oic acid. The molecular weight is 354.49. Alprostadil is a white to off-white crystalline powder with a melting point between 115°C and 116° C. CAVERJECT is available as a sterile freeze-dried powder for intracavernosal use in sizes: 20 mcg and 40 mcg per vial. When reconstituted as directed with 1 mL of bacteriostatic water for injection, the volume of the reconstituted solution is 1.13 mL. Each mL of CAVERJECT contains 20.5 mcg or 41.1 mcg of alprostadil depending on vial strength, 172 mg of lactose, 47 mcg of sodium citrate and 8.4 mg of benzyl alcohol. The deliverable amount of alprostadil is 20 mcg or 40 mcg per mL because approximately 0.5 mcg for the 20 mcg strength and 1.1 mcg for the 40 mcg strength is lost due to adsorption to the vial and syringe. During manufacture, the pH of alprostadil for injection was adjusted with hydrochloric acid and/or sodium hydroxide before lyophilization. The structural formula of alprostadil is represented below."
},
{
"NDCCode": "0009-5181-01",
"PackageDescription": "2 SYRINGE in 1 CARTON (0009-5181-01) / .5 mL in 1 SYRINGE (0009-5181-10) ",
"NDC11Code": "00009-5181-01",
"ProductNDC": "0009-5181",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Caverject Impulse",
"NonProprietaryName": "Alprostadil",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRACAVERNOUS",
"StartMarketingDate": "20020611",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021212",
"LabelerName": "Pharmacia & Upjohn Company LLC",
"SubstanceName": "ALPROSTADIL",
"StrengthNumber": "10",
"StrengthUnit": "ug/.5mL",
"Pharm_Classes": "Genitourinary Arterial Vasodilation [PE], Prostaglandin Analog [EPC], Prostaglandin E1 Agonist [EPC], Prostaglandin Receptor Agonists [MoA], Prostaglandins [CS], Venous Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2024-03-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20020611",
"SamplePackage": "N",
"IndicationAndUsage": "CAVERJECT IMPULSE is a prostaglandin E1 agonist indicated: 1 For the treatment of erectile dysfunction (1.1), 2 As an adjunct to other diagnostic tests in the diagnosis of erectile dysfunction (1.2).",
"Description": "CAVERJECT IMPULSE contains alprostadil a synthetic form of prostaglandin E1 (PGE1) and is designated chemically as (11α,13E,15S)-11,15-dihydroxy-9-oxoprost-13-en-1-oic acid. The molecular weight is 354.49. Alprostadil is a white to off-white crystalline powder with a melting point between 115° and 116°C. Its solubility at 35°C is 8000 micrograms (mcg) per 100 milliliter double distilled water. The structural formula of alprostadil is represented below. CAVERJECT IMPULSE is available as a disposable, single-dose, dual chamber syringe system. The system includes a glass cartridge which contains sterile, freeze-dried alprostadil in the front chamber and sterile bacteriostatic water for injection in the rear chamber. The alprostadil is reconstituted with the sterile bacteriostatic water just before injection. CAVERJECT IMPULSE is available in two strengths for intracavernosal administration. 10 microgram – The reconstituted solution has a volume of 0.64 mL. The delivered volume, 0.5 mL, contains 10 micrograms (mcg) of alprostadil, 324.7 mcg of alpha cyclodextrin, 45.4 mg of lactose, 23.5 mcg of sodium citrate, and 4.45 mg of benzyl alcohol. 20 microgram – The reconstituted solution has a volume of 0.64 mL. The delivered volume, 0.5 mL, contains 20 micrograms (mcg) of alprostadil, 649.3 mcg of alpha cyclodextrin, 45.4 mg of lactose, 23.5 mcg of sodium citrate, and 4.45 mg of benzyl alcohol. During manufacture, the pH of the alprostadil for injection was adjusted with hydrochloric acid and/or sodium hydroxide before lyophilization."
},
{
"NDCCode": "0009-5182-01",
"PackageDescription": "2 SYRINGE in 1 CARTON (0009-5182-01) / .5 mL in 1 SYRINGE (0009-5182-11) ",
"NDC11Code": "00009-5182-01",
"ProductNDC": "0009-5182",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Caverject Impulse",
"NonProprietaryName": "Alprostadil",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRACAVERNOUS",
"StartMarketingDate": "20020611",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021212",
"LabelerName": "Pharmacia & Upjohn Company LLC",
"SubstanceName": "ALPROSTADIL",
"StrengthNumber": "20",
"StrengthUnit": "ug/.5mL",
"Pharm_Classes": "Genitourinary Arterial Vasodilation [PE], Prostaglandin Analog [EPC], Prostaglandin E1 Agonist [EPC], Prostaglandin Receptor Agonists [MoA], Prostaglandins [CS], Venous Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2024-03-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20020611",
"SamplePackage": "N",
"IndicationAndUsage": "CAVERJECT IMPULSE is a prostaglandin E1 agonist indicated: 1 For the treatment of erectile dysfunction (1.1), 2 As an adjunct to other diagnostic tests in the diagnosis of erectile dysfunction (1.2).",
"Description": "CAVERJECT IMPULSE contains alprostadil a synthetic form of prostaglandin E1 (PGE1) and is designated chemically as (11α,13E,15S)-11,15-dihydroxy-9-oxoprost-13-en-1-oic acid. The molecular weight is 354.49. Alprostadil is a white to off-white crystalline powder with a melting point between 115° and 116°C. Its solubility at 35°C is 8000 micrograms (mcg) per 100 milliliter double distilled water. The structural formula of alprostadil is represented below. CAVERJECT IMPULSE is available as a disposable, single-dose, dual chamber syringe system. The system includes a glass cartridge which contains sterile, freeze-dried alprostadil in the front chamber and sterile bacteriostatic water for injection in the rear chamber. The alprostadil is reconstituted with the sterile bacteriostatic water just before injection. CAVERJECT IMPULSE is available in two strengths for intracavernosal administration. 10 microgram – The reconstituted solution has a volume of 0.64 mL. The delivered volume, 0.5 mL, contains 10 micrograms (mcg) of alprostadil, 324.7 mcg of alpha cyclodextrin, 45.4 mg of lactose, 23.5 mcg of sodium citrate, and 4.45 mg of benzyl alcohol. 20 microgram – The reconstituted solution has a volume of 0.64 mL. The delivered volume, 0.5 mL, contains 20 micrograms (mcg) of alprostadil, 649.3 mcg of alpha cyclodextrin, 45.4 mg of lactose, 23.5 mcg of sodium citrate, and 4.45 mg of benzyl alcohol. During manufacture, the pH of the alprostadil for injection was adjusted with hydrochloric acid and/or sodium hydroxide before lyophilization."
},
{
"NDCCode": "0009-7686-04",
"PackageDescription": "6 VIAL, SINGLE-DOSE in 1 PACKAGE (0009-7686-04) / 1 mL in 1 VIAL, SINGLE-DOSE (0009-7686-01) ",
"NDC11Code": "00009-7686-04",
"ProductNDC": "0009-7686",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Caverject",
"NonProprietaryName": "Alprostadil",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRACAVERNOUS",
"StartMarketingDate": "19950706",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020379",
"LabelerName": "Pharmacia & Upjohn Company LLC",
"SubstanceName": "ALPROSTADIL",
"StrengthNumber": "41.1",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Genitourinary Arterial Vasodilation [PE], Prostaglandin Analog [EPC], Prostaglandin E1 Agonist [EPC], Prostaglandin Receptor Agonists [MoA], Prostaglandins [CS], Venous Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2024-05-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19950706",
"SamplePackage": "N",
"IndicationAndUsage": "CAVERJECT is a prostaglandin E1 agonist indicated: 1 For the treatment of erectile dysfunction (1.1). , 2 As an adjunct to other diagnostic tests in the diagnosis of erectile dysfunction (1.2).",
"Description": "CAVERJECT contains alprostadil, a synthetic form of prostaglandin E1 (PGE1), and is designated chemically as (11α,13E,15S)-11,15-dihydroxy-9-oxoprost-13-en-1-oic acid. The molecular weight is 354.49. Alprostadil is a white to off-white crystalline powder with a melting point between 115°C and 116° C. CAVERJECT is available as a sterile freeze-dried powder for intracavernosal use in sizes: 20 mcg and 40 mcg per vial. When reconstituted as directed with 1 mL of bacteriostatic water for injection, the volume of the reconstituted solution is 1.13 mL. Each mL of CAVERJECT contains 20.5 mcg or 41.1 mcg of alprostadil depending on vial strength, 172 mg of lactose, 47 mcg of sodium citrate and 8.4 mg of benzyl alcohol. The deliverable amount of alprostadil is 20 mcg or 40 mcg per mL because approximately 0.5 mcg for the 20 mcg strength and 1.1 mcg for the 40 mcg strength is lost due to adsorption to the vial and syringe. During manufacture, the pH of alprostadil for injection was adjusted with hydrochloric acid and/or sodium hydroxide before lyophilization. The structural formula of alprostadil is represented below."
},
{
"NDCCode": "0037-8110-06",
"PackageDescription": "6 POUCH in 1 CARTON (0037-8110-06) > 1 SUPPOSITORY in 1 POUCH (0037-8110-01) ",
"NDC11Code": "00037-8110-06",
"ProductNDC": "0037-8110",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Muse",
"NonProprietaryName": "Alprostadil",
"DosageFormName": "SUPPOSITORY",
"RouteName": "URETHRAL",
"StartMarketingDate": "20110722",
"EndMarketingDate": "20220430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020700",
"LabelerName": "Meda Pharmaceuticals Inc.",
"SubstanceName": "ALPROSTADIL",
"StrengthNumber": "125",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Genitourinary Arterial Vasodilation [PE], Prostaglandin Analog [EPC], Prostaglandin E1 Agonist [EPC], Prostaglandin Receptor Agonists [MoA], Prostaglandins [CS], Venous Vasodilation [PE]",
"Status": "Deprecated",
"LastUpdate": "2022-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20110722",
"EndMarketingDatePackage": "20220331",
"SamplePackage": "N",
"IndicationAndUsage": "MUSE is indicated for the treatment of erectile dysfunction. Studies that established benefit demonstrated improvements in success rates for sexual intercourse compared with similarly administered placebo.",
"Description": "MUSE® (alprostadil) is a single-use, medicated transurethral system for the delivery of alprostadil to the male urethra. Alprostadil is suspended in polyethylene glycol 1450 (as excipient) and is formed into a medicated pellet (micro-suppository measuring 1.4 mm in diameter by 3 mm or 6 mm in length) that resides in the tip of a translucent hollow applicator. MUSE is administered by inserting the applicator stem into the urethra after urination. The pellet containing alprostadil is delivered by depressing the applicator button (see Figure 1). The components of the delivery system are constructed of medical grade polypropylene. Each MUSE system is packaged in an individual foil pouch. The active ingredient in MUSE is alprostadil, which is chemically identical to the naturally occurring eicosanoid, prostaglandin E1 (PGE1). The chemical name for alprostadil is prost-13-en-1-oic acid, 11,15-dihydroxy-9-oxo-(11α,13E,15S)-(1R,2R,3R)-3-hydroxy-2-[(E)-(3S)-3-hydroxy-1-octenyl]-5-oxo-cyclopentane heptanoic acid, and the molecular weight is 354.49. The empirical formula is C20H34O5. The structural formula of alprostadil is represented below. Alprostadil is a white to off-white crystalline powder with a melting point between 115° and 116°C. Its solubility at 35°C is 8000 mcg per 100 mL double-distilled water. The inactive ingredient in MUSE is polyethylene glycol 1450, USP. There are no other active agents or excipients in MUSE. MUSE is available in 4 dosage strengths: 125 mcg, 250 mcg, 500 mcg, and 1000 mcg."
},
{
"NDCCode": "0037-8110-56",
"PackageDescription": "6 POUCH in 1 CARTON (0037-8110-56) > 1 SUPPOSITORY in 1 POUCH (0037-8110-01) ",
"NDC11Code": "00037-8110-56",
"ProductNDC": "0037-8110",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Muse",
"NonProprietaryName": "Alprostadil",
"DosageFormName": "SUPPOSITORY",
"RouteName": "URETHRAL",
"StartMarketingDate": "20110722",
"EndMarketingDate": "20220430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020700",
"LabelerName": "Meda Pharmaceuticals Inc.",
"SubstanceName": "ALPROSTADIL",
"StrengthNumber": "125",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Genitourinary Arterial Vasodilation [PE], Prostaglandin Analog [EPC], Prostaglandin E1 Agonist [EPC], Prostaglandin Receptor Agonists [MoA], Prostaglandins [CS], Venous Vasodilation [PE]",
"Status": "Deprecated",
"LastUpdate": "2022-05-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20110722",
"EndMarketingDatePackage": "20220430",
"SamplePackage": "Y",
"IndicationAndUsage": "MUSE is indicated for the treatment of erectile dysfunction. Studies that established benefit demonstrated improvements in success rates for sexual intercourse compared with similarly administered placebo.",
"Description": "MUSE® (alprostadil) is a single-use, medicated transurethral system for the delivery of alprostadil to the male urethra. Alprostadil is suspended in polyethylene glycol 1450 (as excipient) and is formed into a medicated pellet (micro-suppository measuring 1.4 mm in diameter by 3 mm or 6 mm in length) that resides in the tip of a translucent hollow applicator. MUSE is administered by inserting the applicator stem into the urethra after urination. The pellet containing alprostadil is delivered by depressing the applicator button (see Figure 1). The components of the delivery system are constructed of medical grade polypropylene. Each MUSE system is packaged in an individual foil pouch. The active ingredient in MUSE is alprostadil, which is chemically identical to the naturally occurring eicosanoid, prostaglandin E1 (PGE1). The chemical name for alprostadil is prost-13-en-1-oic acid, 11,15-dihydroxy-9-oxo-(11α,13E,15S)-(1R,2R,3R)-3-hydroxy-2-[(E)-(3S)-3-hydroxy-1-octenyl]-5-oxo-cyclopentane heptanoic acid, and the molecular weight is 354.49. The empirical formula is C20H34O5. The structural formula of alprostadil is represented below. Alprostadil is a white to off-white crystalline powder with a melting point between 115° and 116°C. Its solubility at 35°C is 8000 mcg per 100 mL double-distilled water. The inactive ingredient in MUSE is polyethylene glycol 1450, USP. There are no other active agents or excipients in MUSE. MUSE is available in 4 dosage strengths: 125 mcg, 250 mcg, 500 mcg, and 1000 mcg."
},
{
"NDCCode": "0093-2203-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (0093-2203-01) ",
"NDC11Code": "00093-2203-01",
"ProductNDC": "0093-2203",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoclopramide",
"NonProprietaryName": "Metoclopramide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19900930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070184",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "METOCLOPRAMIDE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine D2 Antagonists [MoA], Dopamine-2 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19900930",
"SamplePackage": "N",
"IndicationAndUsage": "Metoclopramide tablets are indicated for the: 1 Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy., 2 Relief of symptoms in adults with acute and recurrent diabetic gastroparesis.",
"Description": "Metoclopramide hydrochloride, USP, the active ingredient of metoclopramide tablets, USP is a dopamine-2 receptor antagonist. Metoclopramide hydrochloride (metoclopramide monohydrochloride monohydrate) is a white or practically white, crystalline, odorless or practically odorless powder. It is very soluble in water, freely soluble in alcohol, sparingly soluble in chloroform and practically insoluble in ether. Chemically, it is 4-amino-5-chloro-N-[2-(diethylamino)ethyl]-2-methoxy benzamide monohydrochloride monohydrate. Its structural formula is as follows. C14H22ClN3O2HClH2O M.W. 354.3. Metoclopramide tablets, USP are for oral administration. Metoclopramide tablets, USP are available in 5 mg and 10 mg tablets. : 1 Each metoclopramide tablet USP, 5 mg contains 5 mg metoclopramide (equivalent to 5.91 mg of metoclopramide hydrochloride, USP)., 2 Each metoclopramide tablet USP, 10 mg contains 10 mg metoclopramide (equivalent to 11.82 mg of metoclopramide hydrochloride, USP)."
},
{
"NDCCode": "0093-2203-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (0093-2203-05) ",
"NDC11Code": "00093-2203-05",
"ProductNDC": "0093-2203",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoclopramide",
"NonProprietaryName": "Metoclopramide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19900930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070184",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "METOCLOPRAMIDE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine D2 Antagonists [MoA], Dopamine-2 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19900930",
"SamplePackage": "N",
"IndicationAndUsage": "Metoclopramide tablets are indicated for the: 1 Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy., 2 Relief of symptoms in adults with acute and recurrent diabetic gastroparesis.",
"Description": "Metoclopramide hydrochloride, USP, the active ingredient of metoclopramide tablets, USP is a dopamine-2 receptor antagonist. Metoclopramide hydrochloride (metoclopramide monohydrochloride monohydrate) is a white or practically white, crystalline, odorless or practically odorless powder. It is very soluble in water, freely soluble in alcohol, sparingly soluble in chloroform and practically insoluble in ether. Chemically, it is 4-amino-5-chloro-N-[2-(diethylamino)ethyl]-2-methoxy benzamide monohydrochloride monohydrate. Its structural formula is as follows. C14H22ClN3O2HClH2O M.W. 354.3. Metoclopramide tablets, USP are for oral administration. Metoclopramide tablets, USP are available in 5 mg and 10 mg tablets. : 1 Each metoclopramide tablet USP, 5 mg contains 5 mg metoclopramide (equivalent to 5.91 mg of metoclopramide hydrochloride, USP)., 2 Each metoclopramide tablet USP, 10 mg contains 10 mg metoclopramide (equivalent to 11.82 mg of metoclopramide hydrochloride, USP)."
},
{
"NDCCode": "0093-2203-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (0093-2203-10) ",
"NDC11Code": "00093-2203-10",
"ProductNDC": "0093-2203",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoclopramide",
"NonProprietaryName": "Metoclopramide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19900930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070184",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "METOCLOPRAMIDE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine D2 Antagonists [MoA], Dopamine-2 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19900930",
"SamplePackage": "N",
"IndicationAndUsage": "Metoclopramide tablets are indicated for the: 1 Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy., 2 Relief of symptoms in adults with acute and recurrent diabetic gastroparesis.",
"Description": "Metoclopramide hydrochloride, USP, the active ingredient of metoclopramide tablets, USP is a dopamine-2 receptor antagonist. Metoclopramide hydrochloride (metoclopramide monohydrochloride monohydrate) is a white or practically white, crystalline, odorless or practically odorless powder. It is very soluble in water, freely soluble in alcohol, sparingly soluble in chloroform and practically insoluble in ether. Chemically, it is 4-amino-5-chloro-N-[2-(diethylamino)ethyl]-2-methoxy benzamide monohydrochloride monohydrate. Its structural formula is as follows. C14H22ClN3O2HClH2O M.W. 354.3. Metoclopramide tablets, USP are for oral administration. Metoclopramide tablets, USP are available in 5 mg and 10 mg tablets. : 1 Each metoclopramide tablet USP, 5 mg contains 5 mg metoclopramide (equivalent to 5.91 mg of metoclopramide hydrochloride, USP)., 2 Each metoclopramide tablet USP, 10 mg contains 10 mg metoclopramide (equivalent to 11.82 mg of metoclopramide hydrochloride, USP)."
},
{
"NDCCode": "0093-2204-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (0093-2204-01) ",
"NDC11Code": "00093-2204-01",
"ProductNDC": "0093-2204",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoclopramide",
"NonProprietaryName": "Metoclopramide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19930701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072801",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "METOCLOPRAMIDE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine D2 Antagonists [MoA], Dopamine-2 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19930701",
"SamplePackage": "N",
"IndicationAndUsage": "Metoclopramide tablets are indicated for the: 1 Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy., 2 Relief of symptoms in adults with acute and recurrent diabetic gastroparesis.",
"Description": "Metoclopramide hydrochloride, USP, the active ingredient of metoclopramide tablets, USP is a dopamine-2 receptor antagonist. Metoclopramide hydrochloride (metoclopramide monohydrochloride monohydrate) is a white or practically white, crystalline, odorless or practically odorless powder. It is very soluble in water, freely soluble in alcohol, sparingly soluble in chloroform and practically insoluble in ether. Chemically, it is 4-amino-5-chloro-N-[2-(diethylamino)ethyl]-2-methoxy benzamide monohydrochloride monohydrate. Its structural formula is as follows. C14H22ClN3O2HClH2O M.W. 354.3. Metoclopramide tablets, USP are for oral administration. Metoclopramide tablets, USP are available in 5 mg and 10 mg tablets. : 1 Each metoclopramide tablet USP, 5 mg contains 5 mg metoclopramide (equivalent to 5.91 mg of metoclopramide hydrochloride, USP)., 2 Each metoclopramide tablet USP, 10 mg contains 10 mg metoclopramide (equivalent to 11.82 mg of metoclopramide hydrochloride, USP)."
},
{
"NDCCode": "0093-2204-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (0093-2204-05) ",
"NDC11Code": "00093-2204-05",
"ProductNDC": "0093-2204",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoclopramide",
"NonProprietaryName": "Metoclopramide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19930701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072801",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "METOCLOPRAMIDE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine D2 Antagonists [MoA], Dopamine-2 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "19930701",
"SamplePackage": "N",
"IndicationAndUsage": "Metoclopramide tablets are indicated for the: 1 Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy., 2 Relief of symptoms in adults with acute and recurrent diabetic gastroparesis.",
"Description": "Metoclopramide hydrochloride, USP, the active ingredient of metoclopramide tablets, USP is a dopamine-2 receptor antagonist. Metoclopramide hydrochloride (metoclopramide monohydrochloride monohydrate) is a white or practically white, crystalline, odorless or practically odorless powder. It is very soluble in water, freely soluble in alcohol, sparingly soluble in chloroform and practically insoluble in ether. Chemically, it is 4-amino-5-chloro-N-[2-(diethylamino)ethyl]-2-methoxy benzamide monohydrochloride monohydrate. Its structural formula is as follows. C14H22ClN3O2HClH2O M.W. 354.3. Metoclopramide tablets, USP are for oral administration. Metoclopramide tablets, USP are available in 5 mg and 10 mg tablets. : 1 Each metoclopramide tablet USP, 5 mg contains 5 mg metoclopramide (equivalent to 5.91 mg of metoclopramide hydrochloride, USP)., 2 Each metoclopramide tablet USP, 10 mg contains 10 mg metoclopramide (equivalent to 11.82 mg of metoclopramide hydrochloride, USP)."
}
]
}
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<NDCList>
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<PackageDescription>48 TABLET, FILM COATED in 1 BOTTLE (71610-354-11) </PackageDescription>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tadalafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: 1 erectile dysfunction (ED) ( 1.1) , 2 the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2) , 3 ED and the signs and symptoms of BPH (ED/BPH) ( 1.3) .</IndicationAndUsage>
<Description>Tadalafil, USP is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). The structural formula is. C 22H 19N 3O 4 M.W. 389.41. The chemical designation is (6R,12aR)-2,3,6,7,12,12a-hexahydro-2-methyl-6-(3,4-methylenedioxyphenyl)-pyrazino-[2',1':6,1]pyrido[3,4-b]indole-1,4-dione. It is a white to off-white crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil, USP is available as round or oval-shaped, film-coated tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil, USP and the following inactive ingredients: croscarmellose sodium, iron oxide yellow, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol – part. hydrolyzed, povidone, sodium lauryl sulfate, sodium starch glycolate, sodium stearyl fumarate, talc, and titanium dioxide.</Description>
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<PackageDescription>16 TABLET, FILM COATED in 1 BOTTLE (71610-354-23) </PackageDescription>
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<IndicationAndUsage>Tadalafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: 1 erectile dysfunction (ED) ( 1.1) , 2 the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2) , 3 ED and the signs and symptoms of BPH (ED/BPH) ( 1.3) .</IndicationAndUsage>
<Description>Tadalafil, USP is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). The structural formula is. C 22H 19N 3O 4 M.W. 389.41. The chemical designation is (6R,12aR)-2,3,6,7,12,12a-hexahydro-2-methyl-6-(3,4-methylenedioxyphenyl)-pyrazino-[2',1':6,1]pyrido[3,4-b]indole-1,4-dione. It is a white to off-white crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil, USP is available as round or oval-shaped, film-coated tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil, USP and the following inactive ingredients: croscarmellose sodium, iron oxide yellow, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol – part. hydrolyzed, povidone, sodium lauryl sulfate, sodium starch glycolate, sodium stearyl fumarate, talc, and titanium dioxide.</Description>
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<RouteName>ORAL</RouteName>
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<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191025</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tadalafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: 1 erectile dysfunction (ED) ( 1.1) , 2 the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2) , 3 ED and the signs and symptoms of BPH (ED/BPH) ( 1.3) .</IndicationAndUsage>
<Description>Tadalafil, USP is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). The structural formula is. C 22H 19N 3O 4 M.W. 389.41. The chemical designation is (6R,12aR)-2,3,6,7,12,12a-hexahydro-2-methyl-6-(3,4-methylenedioxyphenyl)-pyrazino-[2',1':6,1]pyrido[3,4-b]indole-1,4-dione. It is a white to off-white crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil, USP is available as round or oval-shaped, film-coated tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil, USP and the following inactive ingredients: croscarmellose sodium, iron oxide yellow, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol – part. hydrolyzed, povidone, sodium lauryl sulfate, sodium starch glycolate, sodium stearyl fumarate, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>43547-354-11</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (43547-354-11) </PackageDescription>
<NDC11Code>43547-0354-11</NDC11Code>
<ProductNDC>43547-354</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril</ProprietaryName>
<NonProprietaryName>Lisinopril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076164</ApplicationNumber>
<LabelerName>Solco healthcare U.S., LLC</LabelerName>
<SubstanceName>LISINOPRIL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisinopril is an angiotensin converting enzyme (ACE) inhibitor indicated for: 1 Treatment of hypertension in adults and pediatric patients 6 years of age and older (1.1), 2 Adjunct therapy for heart failure (1.2), 3 Treatment of Acute Myocardial Infarction (1.3).</IndicationAndUsage>
<Description>Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril tablets, USP, are supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients. 2.5 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, sodium starch glycolate and magnesium stearate. 5 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate and yellow ferric oxide. 10 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate and red ferric oxide. 20 and 30 mg tablets - Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, magnesium stearate and red ferric oxide. 40 mg tablets - Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, magnesium stearate and yellow ferric oxide. *: Pregelatinized starch is a physically modified corn (maize) starch.</Description>
</NDC>
<NDC>
<NDCCode>49884-354-11</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (49884-354-11) </PackageDescription>
<NDC11Code>49884-0354-11</NDC11Code>
<ProductNDC>49884-354</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ambrisentan</ProprietaryName>
<NonProprietaryName>Ambrisentan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190416</StartMarketingDate>
<EndMarketingDate>20221231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209509</ApplicationNumber>
<LabelerName>Par Pharmaceutical, Inc.</LabelerName>
<SubstanceName>AMBRISENTAN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190416</StartMarketingDatePackage>
<EndMarketingDatePackage>20221231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>60687-354-01</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-354-01) > 1 CAPSULE in 1 BLISTER PACK (60687-354-11) </PackageDescription>
<NDC11Code>60687-0354-01</NDC11Code>
<ProductNDC>60687-354</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ramipril</ProprietaryName>
<NonProprietaryName>Ramipril</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170907</StartMarketingDate>
<EndMarketingDate>20210531</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078832</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>RAMIPRIL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170907</StartMarketingDatePackage>
<EndMarketingDatePackage>20210531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68084-354-01</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (68084-354-01) / 1 TABLET in 1 BLISTER PACK (68084-354-11) </PackageDescription>
<NDC11Code>68084-0354-01</NDC11Code>
<ProductNDC>68084-354</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091204</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091393</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone hydrochloride is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration even at recommended doses [seeWarnings and Precautions (5.1)], reserve oxycodone hydrochloride for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products):. Have not been tolerated or are not expected to be tolerated. Have not provided adequate analgesia or are not expected to provide adequate analgesia. Oxycodone hydrochloride should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.</IndicationAndUsage>
<Description>Oxycodone hydrochloride tablets, USP contains oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg, or 30 mg, of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. Oxycodone hydrochloride tablets, USP contains inactive ingredients: corn starch; lactose monohydrate; microcrystalline cellulose; silicon dioxide; sodium starch glycolate; and magnesium stearate. The 10 mg tablet also contains D&C Red No. 27 aluminum lake. The 15 mg tablet also contains D&C Yellow No. 10 aluminum lake and FD&C Blue No. 2 aluminum lake. The 20 mg tablet also contains FD&C Blue No. 2 aluminum lake; FD&C Red No. 40 aluminum lake; and FD&C Yellow No. 6 aluminum lake. The 30 mg tablet also contains FD&C Blue No. 2 aluminum lake. The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.5 mg, 9 mg, 13.5 mg 18 mg and 27 mg, respectively, of oxycodone free base.</Description>
</NDC>
<NDC>
<NDCCode>68428-354-11</NDCCode>
<PackageDescription>300 PELLET in 1 BOTTLE, GLASS (68428-354-11) </PackageDescription>
<NDC11Code>68428-0354-11</NDC11Code>
<ProductNDC>68428-354</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cypripedium Pubescens</ProprietaryName>
<NonProprietaryName>Cypripedium Parvifolum Root</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100203</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-04-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>80714-034-11</NDCCode>
<PackageDescription>6 BOTTLE, PUMP in 1 CARTON (80714-034-11) / 354 mL in 1 BOTTLE, PUMP (80714-034-10) </PackageDescription>
<NDC11Code>80714-0034-11</NDC11Code>
<ProductNDC>80714-034</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Clorox Hand Sanitizer Gel</ProprietaryName>
<NonProprietaryName>Alcohol Hand Sanitizer</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201030</StartMarketingDate>
<EndMarketingDate>20250131</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>New Wave Global Services Inc</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20201030</StartMarketingDatePackage>
<EndMarketingDatePackage>20240331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71610-214-11</NDCCode>
<PackageDescription>48 TABLET, FILM COATED in 1 BOTTLE (71610-214-11) </PackageDescription>
<NDC11Code>71610-0214-11</NDC11Code>
<ProductNDC>71610-214</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tadalafil</ProprietaryName>
<NonProprietaryName>Tadalafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180927</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021368</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>TADALAFIL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: : 1 erectile dysfunction (ED) (1.1) , 2 the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2) , 3 ED and the signs and symptoms of BPH (ED/BPH) (1.3) .</IndicationAndUsage>
<Description>Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is:. The chemical designation is pyrazino[1´,2´:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil is available as almond-shaped tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>71610-273-62</NDCCode>
<PackageDescription>11 TABLET, FILM COATED in 1 BOTTLE (71610-273-62) </PackageDescription>
<NDC11Code>71610-0273-62</NDC11Code>
<ProductNDC>71610-273</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zolpidem Tartrate</ProprietaryName>
<NonProprietaryName>Zolpidem Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190221</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076410</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>ZOLPIDEM TARTRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Depression [PE], GABA A Agonists [MoA], Pyridines [CS], gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Zolpidem tartrate tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies (14)]. The clinical trials performed in support of efficacy were 4 to 5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.</IndicationAndUsage>
<Description>Zolpidem tartrate, USP is a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class and is available in 5 mg and 10 mg strength tablets for oral administration. Chemically, zolpidem tartrate, USP is N, N,6-Trimethyl-2- p-tolylimidazo[1,2-α]pyridine-3-acetamide L-(+)-tartrate. It has the following structure:. (C 19H 21N 3O) 2C 4H 6O 6 M.W. 764.87. Zolpidem tartrate, USP is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. Each zolpidem Tartrate Tablet USP includes the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide; the 5 mg tablet also contains iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>71610-298-11</NDCCode>
<PackageDescription>48 TABLET, FILM COATED in 1 BOTTLE (71610-298-11) </PackageDescription>
<NDC11Code>71610-0298-11</NDC11Code>
<ProductNDC>71610-298</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tadalafil</ProprietaryName>
<NonProprietaryName>Tadalafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190326</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209908</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>TADALAFIL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: erectile dysfunction (ED) (1.1) the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2) ED and the signs and symptoms of BPH (ED/BPH) (1.3) If tadalafil tablet is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks (1.4).</IndicationAndUsage>
<Description>Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the molecular formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is:. The chemical designation is pyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione,6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-(6R-12aR)-. Tadalafil USP is a white or almost white powder that is freely soluble in dimethyl sulfoxide, slightly soluble in methylene chloride and practically insoluble in water. Tadalafil tablets, USP are available as round (2.5 mg and 5 mg) and capsule (10 mg and 20 mg) shaped tablets for oral administration. Each tablet contains 2.5 mg, 5 mg, 10 mg, or 20 mg of tadalafil USP and the following inactive ingredients: colloidal silicon dioxide, copovidone, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyoxyl 40 hydrogenated castor oil, talc, titanium dioxide and triacetin. In addition, 2.5 mg contains FD&C blue #2/indigo carmine aluminum lake. USP dissolution test is pending.</Description>
</NDC>
<NDC>
<NDCCode>71610-324-11</NDCCode>
<PackageDescription>48 TABLET, FILM COATED in 1 BOTTLE (71610-324-11) </PackageDescription>
<NDC11Code>71610-0324-11</NDC11Code>
<ProductNDC>71610-324</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tadalafil</ProprietaryName>
<NonProprietaryName>Tadalafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190326</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208934</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>TADALAFIL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190813</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: 1 erectile dysfunction (ED) (1.1), 2 the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2), 3 ED and the signs and symptoms of BPH (ED/BPH) (1.3).</IndicationAndUsage>
<Description>Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the molecular formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is. The chemical designation is pyrazino[1’,2’:1,6]pyrido[3,4-b]indole-1,4-dione,6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-,(6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil tablets, USP are available as round shaped (2.5 mg) and oval shaped (5 mg, 10 mg, and 20 mg) tablets for oral administration. Each tadalafil tablet, USP contains 2.5 mg, 5 mg, 10 mg, or 20 mg of tadalafil, USP and the following inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer, polyethylene glycol, talc, titanium dioxide, and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>71610-448-11</NDCCode>
<PackageDescription>48 TABLET in 1 BOTTLE (71610-448-11) </PackageDescription>
<NDC11Code>71610-0448-11</NDC11Code>
<ProductNDC>71610-448</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Warfarin Sodium</ProprietaryName>
<NonProprietaryName>Warfarin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110525</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090935</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>WARFARIN SODIUM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200730</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Warfarin sodium tablets, are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.</IndicationAndUsage>
<Description>Warfarin sodium, USP is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. The chemical name of warfarin sodium is 3-(α- acetonylbenzyl)-4-hydroxycoumarin sodium salt, which is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its empirical formula is C 19H 15NaO 4, and its structural formula is represented by the following:. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet, USP intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinized starch, hydroxypropyl cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red #30 aluminum lake. 2 mg tablet contains: FD&C Red #40 aluminum lake and FD&C Blue#2. 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue #2. 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue#2 and FD&C Red # 40 aluminum lake. 4 mg tablet contains: FD&C Blue#2. 5 mg tablet contains: FD&C Yellow # 6 aluminum lake. 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue #2. 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake. 10 mg tablet is dye free.</Description>
</NDC>
<NDC>
<NDCCode>71610-461-11</NDCCode>
<PackageDescription>48 TABLET in 1 BOTTLE (71610-461-11) </PackageDescription>
<NDC11Code>71610-0461-11</NDC11Code>
<ProductNDC>71610-461</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tadalafil</ProprietaryName>
<NonProprietaryName>Tadalafil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190326</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209654</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>TADALAFIL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-10-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200904</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: : 1 erectile dysfunction (ED) (1.1) , 2 the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2) , 3 ED and the signs and symptoms of BPH (ED/BPH) (1.3).</IndicationAndUsage>
<Description>Tadalafil, USP is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the molecular formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is:. The chemical designation is pyrazino[1′,2′:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is white to almost white powder that is practically insoluble in water, freely soluble in dimethyl sulfoxide and slightly soluble in methylene chloride. Tadalafil Tablets, USP are available as light yellow to yellow coloured oval shaped film coated tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, sodium lauryl sulphate, low-substituted hydroxypropyl cellulose and magnesium stearate. The color coating contains hypromellose, titanium dioxide, lactose monohydrate, iron oxide yellow, triacetin and FD&C yellow #5/tartrazine aluminium lake.</Description>
</NDC>
<NDC>
<NDCCode>71610-603-11</NDCCode>
<PackageDescription>48 TABLET, FILM COATED in 1 BOTTLE (71610-603-11) </PackageDescription>
<NDC11Code>71610-0603-11</NDC11Code>
<ProductNDC>71610-603</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tadalafil</ProprietaryName>
<NonProprietaryName>Tadalafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210121</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209744</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>TADALAFIL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211018</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: 1 erectile dysfunction (ED) ( 1.1). , 2 the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2)., 3 ED and the signs and symptoms of BPH (ED/BPH) (1.3).</IndicationAndUsage>
<Description>Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the molecular formula C 22H 19N 3O 4representing a molecular weight of 389.40. The structural formula is:. The chemical designation is pyrazino[1′,2′:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water, freely soluble in dimethyl sulfoxide, slightly soluble in methylene chloride. Tadalafil tablets USP, 2.5 mg, 5 mg, 10 mg and 20 mg are available for oral administration. Each tablet contains 2.5 mg, 5 mg, 10 mg, or 20 mg of tadalafil, USP and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide red (10 mg), iron oxide yellow (5 mg, 10 mg, 20 mg), lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>71610-915-62</NDCCode>
<PackageDescription>11 TABLET, FILM COATED in 1 BOTTLE (71610-915-62) </PackageDescription>
<NDC11Code>71610-0915-62</NDC11Code>
<ProductNDC>71610-915</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zolpidem Tartrate</ProprietaryName>
<NonProprietaryName>Zolpidem Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070423</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077214</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>ZOLPIDEM TARTRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250623</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Zolpidem Tartrate Tablets is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem Tartrate Tablets has been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies ( 14)]. The clinical trials performed in support of efficacy were 4–5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.</IndicationAndUsage>
<Description>Zolpidem Tartrate Tablets, USP contains Zolpidem tartrate, a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class. Zolpidem Tartrate Tablets, USP is available in 5 mg and 10 mg strength tablets for oral administration. Chemically, Zolpidem is N, N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure. Zolpidem Tartrate is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88. Each Zolpidem Tartrate Tablet, USP includes the following inactive ingredients: lactose anhydrous, sodium starch glycolate, colloidal silicon dioxide, microcrystalline cellulose, magnesium stearate. The 10 mg tablets also contain Opadry II (white) and the 5 mg tablets contain Opadry II (pink). Opadry II (white) contains hypromellose, polyeth ylene glycol, polydextrose, titanium dioxide, and triacetin. Opadry II (pink) contains hypromellose, FD&C Red no. 40 aluminum lake, FD&C Blue no. 2 aluminum lake, FD&C Yellow no. 6 aluminum lake, polyeth ylene glycol, polydextrose, titanium dioxide, and triacetin. Meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>0009-0215-05</NDCCode>
<PackageDescription>5 AMPULE in 1 PACKAGE (0009-0215-05) / 1 mL in 1 AMPULE (0009-0215-01) </PackageDescription>
<NDC11Code>00009-0215-05</NDC11Code>
<ProductNDC>0009-0215</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prostin</ProprietaryName>
<ProprietaryNameSuffix>Vr Pediatric</ProprietaryNameSuffix>
<NonProprietaryName>Alprostadil</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVASCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20221003</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018484</ApplicationNumber>
<LabelerName>Pharmacia & Upjohn Company LLC</LabelerName>
<SubstanceName>ALPROSTADIL</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Genitourinary Arterial Vasodilation [PE], Prostaglandin Analog [EPC], Prostaglandin E1 Agonist [EPC], Prostaglandin Receptor Agonists [MoA], Prostaglandins [CS], Venous Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221003</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PROSTIN VR PEDIATRIC Sterile Solution is indicated for palliative, not definitive, therapy to temporarily maintain the patency of the ductus arteriosus until corrective or palliative surgery can be performed in neonates who have congenital heart defects and who depend upon the patent ductus for survival. Such congenital heart defects include pulmonary atresia, pulmonary stenosis, tricuspid atresia, tetralogy of Fallot, interruption of the aortic arch, coarctation of the aorta, or transposition of the great vessels with or without other defects. In infants with restricted pulmonary blood flow, the increase in blood oxygenation is inversely proportional to pretreatment pO2 values; that is, patients with low pO2 values respond best, and patients with pO2 values of 40 torr or more usually have little response. PROSTIN VR PEDIATRIC should be administered only by trained personnel in facilities that provide pediatric intensive care.</IndicationAndUsage>
<Description>PROSTIN VR PEDIATRIC Sterile Solution for intravascular infusion contains 500 micrograms alprostadil, more commonly known as prostaglandin E1, in 1.0 mL dehydrated alcohol. The chemical name for alprostadil is (11α,13E,15S)-11,15 dihydroxy-9-oxo-prost-13-en-1-oic acid, and the molecular weight is 354.49. Alprostadil is a white to off-white crystalline powder with a melting point between 110° and 116°C. Its solubility at 35°C is 8000 micrograms per 100 mL double distilled water. Structural Formula.</Description>
</NDC>
<NDC>
<NDCCode>0009-3169-06</NDCCode>
<PackageDescription>5 AMPULE in 1 PACKAGE (0009-3169-06) / 1 mL in 1 AMPULE (0009-3169-01) </PackageDescription>
<NDC11Code>00009-3169-06</NDC11Code>
<ProductNDC>0009-3169</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prostin</ProprietaryName>
<ProprietaryNameSuffix>Vr Pediatric</ProprietaryNameSuffix>
<NonProprietaryName>Alprostadil</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVASCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>19811016</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018484</ApplicationNumber>
<LabelerName>Pharmacia & Upjohn Company LLC</LabelerName>
<SubstanceName>ALPROSTADIL</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Genitourinary Arterial Vasodilation [PE], Prostaglandin Analog [EPC], Prostaglandin E1 Agonist [EPC], Prostaglandin Receptor Agonists [MoA], Prostaglandins [CS], Venous Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19811016</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PROSTIN VR PEDIATRIC Sterile Solution is indicated for palliative, not definitive, therapy to temporarily maintain the patency of the ductus arteriosus until corrective or palliative surgery can be performed in neonates who have congenital heart defects and who depend upon the patent ductus for survival. Such congenital heart defects include pulmonary atresia, pulmonary stenosis, tricuspid atresia, tetralogy of Fallot, interruption of the aortic arch, coarctation of the aorta, or transposition of the great vessels with or without other defects. In infants with restricted pulmonary blood flow, the increase in blood oxygenation is inversely proportional to pretreatment pO2 values; that is, patients with low pO2 values respond best, and patients with pO2 values of 40 torr or more usually have little response. PROSTIN VR PEDIATRIC should be administered only by trained personnel in facilities that provide pediatric intensive care.</IndicationAndUsage>
<Description>PROSTIN VR PEDIATRIC Sterile Solution for intravascular infusion contains 500 micrograms alprostadil, more commonly known as prostaglandin E1, in 1.0 mL dehydrated alcohol. The chemical name for alprostadil is (11α,13E,15S)-11,15 dihydroxy-9-oxo-prost-13-en-1-oic acid, and the molecular weight is 354.49. Alprostadil is a white to off-white crystalline powder with a melting point between 110° and 116°C. Its solubility at 35°C is 8000 micrograms per 100 mL double distilled water. Structural Formula.</Description>
</NDC>
<NDC>
<NDCCode>0009-3701-05</NDCCode>
<PackageDescription>6 VIAL, SINGLE-DOSE in 1 PACKAGE (0009-3701-05) / 1 mL in 1 VIAL, SINGLE-DOSE (0009-3701-08) </PackageDescription>
<NDC11Code>00009-3701-05</NDC11Code>
<ProductNDC>0009-3701</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Caverject</ProprietaryName>
<NonProprietaryName>Alprostadil</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRACAVERNOUS</RouteName>
<StartMarketingDate>19950706</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020379</ApplicationNumber>
<LabelerName>Pharmacia & Upjohn Company LLC</LabelerName>
<SubstanceName>ALPROSTADIL</SubstanceName>
<StrengthNumber>20.5</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Genitourinary Arterial Vasodilation [PE], Prostaglandin Analog [EPC], Prostaglandin E1 Agonist [EPC], Prostaglandin Receptor Agonists [MoA], Prostaglandins [CS], Venous Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19950706</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CAVERJECT is a prostaglandin E1 agonist indicated: 1 For the treatment of erectile dysfunction (1.1). , 2 As an adjunct to other diagnostic tests in the diagnosis of erectile dysfunction (1.2).</IndicationAndUsage>
<Description>CAVERJECT contains alprostadil, a synthetic form of prostaglandin E1 (PGE1), and is designated chemically as (11α,13E,15S)-11,15-dihydroxy-9-oxoprost-13-en-1-oic acid. The molecular weight is 354.49. Alprostadil is a white to off-white crystalline powder with a melting point between 115°C and 116° C. CAVERJECT is available as a sterile freeze-dried powder for intracavernosal use in sizes: 20 mcg and 40 mcg per vial. When reconstituted as directed with 1 mL of bacteriostatic water for injection, the volume of the reconstituted solution is 1.13 mL. Each mL of CAVERJECT contains 20.5 mcg or 41.1 mcg of alprostadil depending on vial strength, 172 mg of lactose, 47 mcg of sodium citrate and 8.4 mg of benzyl alcohol. The deliverable amount of alprostadil is 20 mcg or 40 mcg per mL because approximately 0.5 mcg for the 20 mcg strength and 1.1 mcg for the 40 mcg strength is lost due to adsorption to the vial and syringe. During manufacture, the pH of alprostadil for injection was adjusted with hydrochloric acid and/or sodium hydroxide before lyophilization. The structural formula of alprostadil is represented below.</Description>
</NDC>
<NDC>
<NDCCode>0009-5181-01</NDCCode>
<PackageDescription>2 SYRINGE in 1 CARTON (0009-5181-01) / .5 mL in 1 SYRINGE (0009-5181-10) </PackageDescription>
<NDC11Code>00009-5181-01</NDC11Code>
<ProductNDC>0009-5181</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Caverject Impulse</ProprietaryName>
<NonProprietaryName>Alprostadil</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRACAVERNOUS</RouteName>
<StartMarketingDate>20020611</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021212</ApplicationNumber>
<LabelerName>Pharmacia & Upjohn Company LLC</LabelerName>
<SubstanceName>ALPROSTADIL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>ug/.5mL</StrengthUnit>
<Pharm_Classes>Genitourinary Arterial Vasodilation [PE], Prostaglandin Analog [EPC], Prostaglandin E1 Agonist [EPC], Prostaglandin Receptor Agonists [MoA], Prostaglandins [CS], Venous Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20020611</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CAVERJECT IMPULSE is a prostaglandin E1 agonist indicated: 1 For the treatment of erectile dysfunction (1.1), 2 As an adjunct to other diagnostic tests in the diagnosis of erectile dysfunction (1.2).</IndicationAndUsage>
<Description>CAVERJECT IMPULSE contains alprostadil a synthetic form of prostaglandin E1 (PGE1) and is designated chemically as (11α,13E,15S)-11,15-dihydroxy-9-oxoprost-13-en-1-oic acid. The molecular weight is 354.49. Alprostadil is a white to off-white crystalline powder with a melting point between 115° and 116°C. Its solubility at 35°C is 8000 micrograms (mcg) per 100 milliliter double distilled water. The structural formula of alprostadil is represented below. CAVERJECT IMPULSE is available as a disposable, single-dose, dual chamber syringe system. The system includes a glass cartridge which contains sterile, freeze-dried alprostadil in the front chamber and sterile bacteriostatic water for injection in the rear chamber. The alprostadil is reconstituted with the sterile bacteriostatic water just before injection. CAVERJECT IMPULSE is available in two strengths for intracavernosal administration. 10 microgram – The reconstituted solution has a volume of 0.64 mL. The delivered volume, 0.5 mL, contains 10 micrograms (mcg) of alprostadil, 324.7 mcg of alpha cyclodextrin, 45.4 mg of lactose, 23.5 mcg of sodium citrate, and 4.45 mg of benzyl alcohol. 20 microgram – The reconstituted solution has a volume of 0.64 mL. The delivered volume, 0.5 mL, contains 20 micrograms (mcg) of alprostadil, 649.3 mcg of alpha cyclodextrin, 45.4 mg of lactose, 23.5 mcg of sodium citrate, and 4.45 mg of benzyl alcohol. During manufacture, the pH of the alprostadil for injection was adjusted with hydrochloric acid and/or sodium hydroxide before lyophilization.</Description>
</NDC>
<NDC>
<NDCCode>0009-5182-01</NDCCode>
<PackageDescription>2 SYRINGE in 1 CARTON (0009-5182-01) / .5 mL in 1 SYRINGE (0009-5182-11) </PackageDescription>
<NDC11Code>00009-5182-01</NDC11Code>
<ProductNDC>0009-5182</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Caverject Impulse</ProprietaryName>
<NonProprietaryName>Alprostadil</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRACAVERNOUS</RouteName>
<StartMarketingDate>20020611</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021212</ApplicationNumber>
<LabelerName>Pharmacia & Upjohn Company LLC</LabelerName>
<SubstanceName>ALPROSTADIL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>ug/.5mL</StrengthUnit>
<Pharm_Classes>Genitourinary Arterial Vasodilation [PE], Prostaglandin Analog [EPC], Prostaglandin E1 Agonist [EPC], Prostaglandin Receptor Agonists [MoA], Prostaglandins [CS], Venous Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20020611</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CAVERJECT IMPULSE is a prostaglandin E1 agonist indicated: 1 For the treatment of erectile dysfunction (1.1), 2 As an adjunct to other diagnostic tests in the diagnosis of erectile dysfunction (1.2).</IndicationAndUsage>
<Description>CAVERJECT IMPULSE contains alprostadil a synthetic form of prostaglandin E1 (PGE1) and is designated chemically as (11α,13E,15S)-11,15-dihydroxy-9-oxoprost-13-en-1-oic acid. The molecular weight is 354.49. Alprostadil is a white to off-white crystalline powder with a melting point between 115° and 116°C. Its solubility at 35°C is 8000 micrograms (mcg) per 100 milliliter double distilled water. The structural formula of alprostadil is represented below. CAVERJECT IMPULSE is available as a disposable, single-dose, dual chamber syringe system. The system includes a glass cartridge which contains sterile, freeze-dried alprostadil in the front chamber and sterile bacteriostatic water for injection in the rear chamber. The alprostadil is reconstituted with the sterile bacteriostatic water just before injection. CAVERJECT IMPULSE is available in two strengths for intracavernosal administration. 10 microgram – The reconstituted solution has a volume of 0.64 mL. The delivered volume, 0.5 mL, contains 10 micrograms (mcg) of alprostadil, 324.7 mcg of alpha cyclodextrin, 45.4 mg of lactose, 23.5 mcg of sodium citrate, and 4.45 mg of benzyl alcohol. 20 microgram – The reconstituted solution has a volume of 0.64 mL. The delivered volume, 0.5 mL, contains 20 micrograms (mcg) of alprostadil, 649.3 mcg of alpha cyclodextrin, 45.4 mg of lactose, 23.5 mcg of sodium citrate, and 4.45 mg of benzyl alcohol. During manufacture, the pH of the alprostadil for injection was adjusted with hydrochloric acid and/or sodium hydroxide before lyophilization.</Description>
</NDC>
<NDC>
<NDCCode>0009-7686-04</NDCCode>
<PackageDescription>6 VIAL, SINGLE-DOSE in 1 PACKAGE (0009-7686-04) / 1 mL in 1 VIAL, SINGLE-DOSE (0009-7686-01) </PackageDescription>
<NDC11Code>00009-7686-04</NDC11Code>
<ProductNDC>0009-7686</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Caverject</ProprietaryName>
<NonProprietaryName>Alprostadil</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRACAVERNOUS</RouteName>
<StartMarketingDate>19950706</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020379</ApplicationNumber>
<LabelerName>Pharmacia & Upjohn Company LLC</LabelerName>
<SubstanceName>ALPROSTADIL</SubstanceName>
<StrengthNumber>41.1</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Genitourinary Arterial Vasodilation [PE], Prostaglandin Analog [EPC], Prostaglandin E1 Agonist [EPC], Prostaglandin Receptor Agonists [MoA], Prostaglandins [CS], Venous Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19950706</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CAVERJECT is a prostaglandin E1 agonist indicated: 1 For the treatment of erectile dysfunction (1.1). , 2 As an adjunct to other diagnostic tests in the diagnosis of erectile dysfunction (1.2).</IndicationAndUsage>
<Description>CAVERJECT contains alprostadil, a synthetic form of prostaglandin E1 (PGE1), and is designated chemically as (11α,13E,15S)-11,15-dihydroxy-9-oxoprost-13-en-1-oic acid. The molecular weight is 354.49. Alprostadil is a white to off-white crystalline powder with a melting point between 115°C and 116° C. CAVERJECT is available as a sterile freeze-dried powder for intracavernosal use in sizes: 20 mcg and 40 mcg per vial. When reconstituted as directed with 1 mL of bacteriostatic water for injection, the volume of the reconstituted solution is 1.13 mL. Each mL of CAVERJECT contains 20.5 mcg or 41.1 mcg of alprostadil depending on vial strength, 172 mg of lactose, 47 mcg of sodium citrate and 8.4 mg of benzyl alcohol. The deliverable amount of alprostadil is 20 mcg or 40 mcg per mL because approximately 0.5 mcg for the 20 mcg strength and 1.1 mcg for the 40 mcg strength is lost due to adsorption to the vial and syringe. During manufacture, the pH of alprostadil for injection was adjusted with hydrochloric acid and/or sodium hydroxide before lyophilization. The structural formula of alprostadil is represented below.</Description>
</NDC>
<NDC>
<NDCCode>0037-8110-06</NDCCode>
<PackageDescription>6 POUCH in 1 CARTON (0037-8110-06) > 1 SUPPOSITORY in 1 POUCH (0037-8110-01) </PackageDescription>
<NDC11Code>00037-8110-06</NDC11Code>
<ProductNDC>0037-8110</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Muse</ProprietaryName>
<NonProprietaryName>Alprostadil</NonProprietaryName>
<DosageFormName>SUPPOSITORY</DosageFormName>
<RouteName>URETHRAL</RouteName>
<StartMarketingDate>20110722</StartMarketingDate>
<EndMarketingDate>20220430</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020700</ApplicationNumber>
<LabelerName>Meda Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ALPROSTADIL</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Genitourinary Arterial Vasodilation [PE], Prostaglandin Analog [EPC], Prostaglandin E1 Agonist [EPC], Prostaglandin Receptor Agonists [MoA], Prostaglandins [CS], Venous Vasodilation [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20110722</StartMarketingDatePackage>
<EndMarketingDatePackage>20220331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>MUSE is indicated for the treatment of erectile dysfunction. Studies that established benefit demonstrated improvements in success rates for sexual intercourse compared with similarly administered placebo.</IndicationAndUsage>
<Description>MUSE® (alprostadil) is a single-use, medicated transurethral system for the delivery of alprostadil to the male urethra. Alprostadil is suspended in polyethylene glycol 1450 (as excipient) and is formed into a medicated pellet (micro-suppository measuring 1.4 mm in diameter by 3 mm or 6 mm in length) that resides in the tip of a translucent hollow applicator. MUSE is administered by inserting the applicator stem into the urethra after urination. The pellet containing alprostadil is delivered by depressing the applicator button (see Figure 1). The components of the delivery system are constructed of medical grade polypropylene. Each MUSE system is packaged in an individual foil pouch. The active ingredient in MUSE is alprostadil, which is chemically identical to the naturally occurring eicosanoid, prostaglandin E1 (PGE1). The chemical name for alprostadil is prost-13-en-1-oic acid, 11,15-dihydroxy-9-oxo-(11α,13E,15S)-(1R,2R,3R)-3-hydroxy-2-[(E)-(3S)-3-hydroxy-1-octenyl]-5-oxo-cyclopentane heptanoic acid, and the molecular weight is 354.49. The empirical formula is C20H34O5. The structural formula of alprostadil is represented below. Alprostadil is a white to off-white crystalline powder with a melting point between 115° and 116°C. Its solubility at 35°C is 8000 mcg per 100 mL double-distilled water. The inactive ingredient in MUSE is polyethylene glycol 1450, USP. There are no other active agents or excipients in MUSE. MUSE is available in 4 dosage strengths: 125 mcg, 250 mcg, 500 mcg, and 1000 mcg.</Description>
</NDC>
<NDC>
<NDCCode>0037-8110-56</NDCCode>
<PackageDescription>6 POUCH in 1 CARTON (0037-8110-56) > 1 SUPPOSITORY in 1 POUCH (0037-8110-01) </PackageDescription>
<NDC11Code>00037-8110-56</NDC11Code>
<ProductNDC>0037-8110</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Muse</ProprietaryName>
<NonProprietaryName>Alprostadil</NonProprietaryName>
<DosageFormName>SUPPOSITORY</DosageFormName>
<RouteName>URETHRAL</RouteName>
<StartMarketingDate>20110722</StartMarketingDate>
<EndMarketingDate>20220430</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020700</ApplicationNumber>
<LabelerName>Meda Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ALPROSTADIL</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Genitourinary Arterial Vasodilation [PE], Prostaglandin Analog [EPC], Prostaglandin E1 Agonist [EPC], Prostaglandin Receptor Agonists [MoA], Prostaglandins [CS], Venous Vasodilation [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-05-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20110722</StartMarketingDatePackage>
<EndMarketingDatePackage>20220430</EndMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>MUSE is indicated for the treatment of erectile dysfunction. Studies that established benefit demonstrated improvements in success rates for sexual intercourse compared with similarly administered placebo.</IndicationAndUsage>
<Description>MUSE® (alprostadil) is a single-use, medicated transurethral system for the delivery of alprostadil to the male urethra. Alprostadil is suspended in polyethylene glycol 1450 (as excipient) and is formed into a medicated pellet (micro-suppository measuring 1.4 mm in diameter by 3 mm or 6 mm in length) that resides in the tip of a translucent hollow applicator. MUSE is administered by inserting the applicator stem into the urethra after urination. The pellet containing alprostadil is delivered by depressing the applicator button (see Figure 1). The components of the delivery system are constructed of medical grade polypropylene. Each MUSE system is packaged in an individual foil pouch. The active ingredient in MUSE is alprostadil, which is chemically identical to the naturally occurring eicosanoid, prostaglandin E1 (PGE1). The chemical name for alprostadil is prost-13-en-1-oic acid, 11,15-dihydroxy-9-oxo-(11α,13E,15S)-(1R,2R,3R)-3-hydroxy-2-[(E)-(3S)-3-hydroxy-1-octenyl]-5-oxo-cyclopentane heptanoic acid, and the molecular weight is 354.49. The empirical formula is C20H34O5. The structural formula of alprostadil is represented below. Alprostadil is a white to off-white crystalline powder with a melting point between 115° and 116°C. Its solubility at 35°C is 8000 mcg per 100 mL double-distilled water. The inactive ingredient in MUSE is polyethylene glycol 1450, USP. There are no other active agents or excipients in MUSE. MUSE is available in 4 dosage strengths: 125 mcg, 250 mcg, 500 mcg, and 1000 mcg.</Description>
</NDC>
<NDC>
<NDCCode>0093-2203-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0093-2203-01) </PackageDescription>
<NDC11Code>00093-2203-01</NDC11Code>
<ProductNDC>0093-2203</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoclopramide</ProprietaryName>
<NonProprietaryName>Metoclopramide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19900930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070184</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>METOCLOPRAMIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine D2 Antagonists [MoA], Dopamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19900930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoclopramide tablets are indicated for the: 1 Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy., 2 Relief of symptoms in adults with acute and recurrent diabetic gastroparesis.</IndicationAndUsage>
<Description>Metoclopramide hydrochloride, USP, the active ingredient of metoclopramide tablets, USP is a dopamine-2 receptor antagonist. Metoclopramide hydrochloride (metoclopramide monohydrochloride monohydrate) is a white or practically white, crystalline, odorless or practically odorless powder. It is very soluble in water, freely soluble in alcohol, sparingly soluble in chloroform and practically insoluble in ether. Chemically, it is 4-amino-5-chloro-N-[2-(diethylamino)ethyl]-2-methoxy benzamide monohydrochloride monohydrate. Its structural formula is as follows. C14H22ClN3O2HClH2O M.W. 354.3. Metoclopramide tablets, USP are for oral administration. Metoclopramide tablets, USP are available in 5 mg and 10 mg tablets. : 1 Each metoclopramide tablet USP, 5 mg contains 5 mg metoclopramide (equivalent to 5.91 mg of metoclopramide hydrochloride, USP)., 2 Each metoclopramide tablet USP, 10 mg contains 10 mg metoclopramide (equivalent to 11.82 mg of metoclopramide hydrochloride, USP).</Description>
</NDC>
<NDC>
<NDCCode>0093-2203-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (0093-2203-05) </PackageDescription>
<NDC11Code>00093-2203-05</NDC11Code>
<ProductNDC>0093-2203</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoclopramide</ProprietaryName>
<NonProprietaryName>Metoclopramide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19900930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070184</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>METOCLOPRAMIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine D2 Antagonists [MoA], Dopamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19900930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoclopramide tablets are indicated for the: 1 Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy., 2 Relief of symptoms in adults with acute and recurrent diabetic gastroparesis.</IndicationAndUsage>
<Description>Metoclopramide hydrochloride, USP, the active ingredient of metoclopramide tablets, USP is a dopamine-2 receptor antagonist. Metoclopramide hydrochloride (metoclopramide monohydrochloride monohydrate) is a white or practically white, crystalline, odorless or practically odorless powder. It is very soluble in water, freely soluble in alcohol, sparingly soluble in chloroform and practically insoluble in ether. Chemically, it is 4-amino-5-chloro-N-[2-(diethylamino)ethyl]-2-methoxy benzamide monohydrochloride monohydrate. Its structural formula is as follows. C14H22ClN3O2HClH2O M.W. 354.3. Metoclopramide tablets, USP are for oral administration. Metoclopramide tablets, USP are available in 5 mg and 10 mg tablets. : 1 Each metoclopramide tablet USP, 5 mg contains 5 mg metoclopramide (equivalent to 5.91 mg of metoclopramide hydrochloride, USP)., 2 Each metoclopramide tablet USP, 10 mg contains 10 mg metoclopramide (equivalent to 11.82 mg of metoclopramide hydrochloride, USP).</Description>
</NDC>
<NDC>
<NDCCode>0093-2203-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (0093-2203-10) </PackageDescription>
<NDC11Code>00093-2203-10</NDC11Code>
<ProductNDC>0093-2203</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoclopramide</ProprietaryName>
<NonProprietaryName>Metoclopramide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19900930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070184</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>METOCLOPRAMIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine D2 Antagonists [MoA], Dopamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19900930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoclopramide tablets are indicated for the: 1 Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy., 2 Relief of symptoms in adults with acute and recurrent diabetic gastroparesis.</IndicationAndUsage>
<Description>Metoclopramide hydrochloride, USP, the active ingredient of metoclopramide tablets, USP is a dopamine-2 receptor antagonist. Metoclopramide hydrochloride (metoclopramide monohydrochloride monohydrate) is a white or practically white, crystalline, odorless or practically odorless powder. It is very soluble in water, freely soluble in alcohol, sparingly soluble in chloroform and practically insoluble in ether. Chemically, it is 4-amino-5-chloro-N-[2-(diethylamino)ethyl]-2-methoxy benzamide monohydrochloride monohydrate. Its structural formula is as follows. C14H22ClN3O2HClH2O M.W. 354.3. Metoclopramide tablets, USP are for oral administration. Metoclopramide tablets, USP are available in 5 mg and 10 mg tablets. : 1 Each metoclopramide tablet USP, 5 mg contains 5 mg metoclopramide (equivalent to 5.91 mg of metoclopramide hydrochloride, USP)., 2 Each metoclopramide tablet USP, 10 mg contains 10 mg metoclopramide (equivalent to 11.82 mg of metoclopramide hydrochloride, USP).</Description>
</NDC>
<NDC>
<NDCCode>0093-2204-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0093-2204-01) </PackageDescription>
<NDC11Code>00093-2204-01</NDC11Code>
<ProductNDC>0093-2204</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoclopramide</ProprietaryName>
<NonProprietaryName>Metoclopramide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19930701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072801</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>METOCLOPRAMIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine D2 Antagonists [MoA], Dopamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19930701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoclopramide tablets are indicated for the: 1 Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy., 2 Relief of symptoms in adults with acute and recurrent diabetic gastroparesis.</IndicationAndUsage>
<Description>Metoclopramide hydrochloride, USP, the active ingredient of metoclopramide tablets, USP is a dopamine-2 receptor antagonist. Metoclopramide hydrochloride (metoclopramide monohydrochloride monohydrate) is a white or practically white, crystalline, odorless or practically odorless powder. It is very soluble in water, freely soluble in alcohol, sparingly soluble in chloroform and practically insoluble in ether. Chemically, it is 4-amino-5-chloro-N-[2-(diethylamino)ethyl]-2-methoxy benzamide monohydrochloride monohydrate. Its structural formula is as follows. C14H22ClN3O2HClH2O M.W. 354.3. Metoclopramide tablets, USP are for oral administration. Metoclopramide tablets, USP are available in 5 mg and 10 mg tablets. : 1 Each metoclopramide tablet USP, 5 mg contains 5 mg metoclopramide (equivalent to 5.91 mg of metoclopramide hydrochloride, USP)., 2 Each metoclopramide tablet USP, 10 mg contains 10 mg metoclopramide (equivalent to 11.82 mg of metoclopramide hydrochloride, USP).</Description>
</NDC>
<NDC>
<NDCCode>0093-2204-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (0093-2204-05) </PackageDescription>
<NDC11Code>00093-2204-05</NDC11Code>
<ProductNDC>0093-2204</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoclopramide</ProprietaryName>
<NonProprietaryName>Metoclopramide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19930701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072801</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>METOCLOPRAMIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine D2 Antagonists [MoA], Dopamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19930701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoclopramide tablets are indicated for the: 1 Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy., 2 Relief of symptoms in adults with acute and recurrent diabetic gastroparesis.</IndicationAndUsage>
<Description>Metoclopramide hydrochloride, USP, the active ingredient of metoclopramide tablets, USP is a dopamine-2 receptor antagonist. Metoclopramide hydrochloride (metoclopramide monohydrochloride monohydrate) is a white or practically white, crystalline, odorless or practically odorless powder. It is very soluble in water, freely soluble in alcohol, sparingly soluble in chloroform and practically insoluble in ether. Chemically, it is 4-amino-5-chloro-N-[2-(diethylamino)ethyl]-2-methoxy benzamide monohydrochloride monohydrate. Its structural formula is as follows. C14H22ClN3O2HClH2O M.W. 354.3. Metoclopramide tablets, USP are for oral administration. Metoclopramide tablets, USP are available in 5 mg and 10 mg tablets. : 1 Each metoclopramide tablet USP, 5 mg contains 5 mg metoclopramide (equivalent to 5.91 mg of metoclopramide hydrochloride, USP)., 2 Each metoclopramide tablet USP, 10 mg contains 10 mg metoclopramide (equivalent to 11.82 mg of metoclopramide hydrochloride, USP).</Description>
</NDC>
</NDCList>