{
"NDC": [
{
"NDCCode": "72789-463-90",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (72789-463-90) ",
"NDC11Code": "72789-0463-90",
"ProductNDC": "72789-463",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glipizide",
"NonProprietaryName": "Glipizide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231003",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214874",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "GLIPIZIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241223",
"SamplePackage": "N",
"IndicationAndUsage": "Glipizide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazine-carboxamido)ethyl]phenyl]sulfonyl]urea. The molecular formula is C 21H 27N 5O 4S; the molecular weight is 445.55; the structural formula is shown below:. Glipizide is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. Glipizide tablets for oral use are available in 2.5 mg, 5 mg, 10 mg and 15 mg strengths. Inactive ingredients are: colloidal silicon dioxide; croscarmellose sodium, lactose anhydrous; microcrystalline cellulose and stearic acid. Meets USP Dissolution test 2."
},
{
"NDCCode": "72789-463-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (72789-463-60) ",
"NDC11Code": "72789-0463-60",
"ProductNDC": "72789-463",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glipizide",
"NonProprietaryName": "Glipizide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231003",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214874",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "GLIPIZIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260928",
"SamplePackage": "N",
"IndicationAndUsage": "Glipizide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazine-carboxamido)ethyl]phenyl]sulfonyl]urea. The molecular formula is C 21H 27N 5O 4S; the molecular weight is 445.55; the structural formula is shown below:. Glipizide is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. Glipizide tablets for oral use are available in 2.5 mg, 5 mg, 10 mg and 15 mg strengths. Inactive ingredients are: colloidal silicon dioxide; croscarmellose sodium, lactose anhydrous; microcrystalline cellulose and stearic acid. Meets USP Dissolution test 2."
},
{
"NDCCode": "72789-463-86",
"PackageDescription": "360 TABLET in 1 BOTTLE, PLASTIC (72789-463-86) ",
"NDC11Code": "72789-0463-86",
"ProductNDC": "72789-463",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glipizide",
"NonProprietaryName": "Glipizide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231003",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214874",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "GLIPIZIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260217",
"SamplePackage": "N",
"IndicationAndUsage": "Glipizide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazine-carboxamido)ethyl]phenyl]sulfonyl]urea. The molecular formula is C 21H 27N 5O 4S; the molecular weight is 445.55; the structural formula is shown below:. Glipizide is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. Glipizide tablets for oral use are available in 2.5 mg, 5 mg, 10 mg and 15 mg strengths. Inactive ingredients are: colloidal silicon dioxide; croscarmellose sodium, lactose anhydrous; microcrystalline cellulose and stearic acid. Meets USP Dissolution test 2."
},
{
"NDCCode": "72789-463-93",
"PackageDescription": "180 TABLET in 1 BOTTLE, PLASTIC (72789-463-93) ",
"NDC11Code": "72789-0463-93",
"ProductNDC": "72789-463",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glipizide",
"NonProprietaryName": "Glipizide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231003",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214874",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "GLIPIZIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241223",
"SamplePackage": "N",
"IndicationAndUsage": "Glipizide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazine-carboxamido)ethyl]phenyl]sulfonyl]urea. The molecular formula is C 21H 27N 5O 4S; the molecular weight is 445.55; the structural formula is shown below:. Glipizide is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. Glipizide tablets for oral use are available in 2.5 mg, 5 mg, 10 mg and 15 mg strengths. Inactive ingredients are: colloidal silicon dioxide; croscarmellose sodium, lactose anhydrous; microcrystalline cellulose and stearic acid. Meets USP Dissolution test 2."
},
{
"NDCCode": "72789-463-95",
"PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (72789-463-95) ",
"NDC11Code": "72789-0463-95",
"ProductNDC": "72789-463",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glipizide",
"NonProprietaryName": "Glipizide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231003",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214874",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "GLIPIZIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241223",
"SamplePackage": "N",
"IndicationAndUsage": "Glipizide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazine-carboxamido)ethyl]phenyl]sulfonyl]urea. The molecular formula is C 21H 27N 5O 4S; the molecular weight is 445.55; the structural formula is shown below:. Glipizide is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. Glipizide tablets for oral use are available in 2.5 mg, 5 mg, 10 mg and 15 mg strengths. Inactive ingredients are: colloidal silicon dioxide; croscarmellose sodium, lactose anhydrous; microcrystalline cellulose and stearic acid. Meets USP Dissolution test 2."
},
{
"NDCCode": "13668-463-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (13668-463-90) ",
"NDC11Code": "13668-0463-90",
"ProductNDC": "13668-463",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Itraconazole",
"NonProprietaryName": "Itraconazole",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20180824",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209460",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "ITRACONAZOLE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180824",
"SamplePackage": "N",
"IndicationAndUsage": "Itraconazole capsules are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients: 1 Blastomycosis, pulmonary and extrapulmonary, 2 Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis, and, 3 Aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy.",
"Description": "Itraconazole, USP is an azole antifungal agent. Itraconazole is a 1:1:1:1 racemic mixture of four diastereomers (two enantiomeric pairs), each possessing three chiral centers. It may be represented by the following structural formula and nomenclature. 3H-1,2,4-Triazol-3-one,4-[4-[4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-2-4-dihydro-2-(1-methylpropyl)-. or. (±)-1-sec-Butyl-4-[p-[4-[p-[[(2R*,4S*)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-Δ2-1,2,4-triazolin-5-one. Itraconazole USP has a molecular formula of C35H38Cl2N8O4 and a molecular weight of 705.63. It is a white or almost white powder. It is practically insoluble in water, very slightly soluble in alcohol, freely soluble in methylene chloride, and sparingly soluble in tetrahydrofuran. It has a pKa of 3.7* (*Merck Index, Fifteenth Edition) and a log (n-octanol/water) partition coefficient of 5.66 at pH 8.1. Itraconazole capsules, USP contain 100 mg of itraconazole, USP coated on sugar spheres (composed of maize starch and sucrose). Inactive ingredients are hard gelatin capsule, hypromellose, polyethylene glycol, sugar spheres & talc. In addition, the blue opaque capsule shell contains FD&C Blue No. 1, FD&C Blue No. 2, gelatin & titanium dioxide and the pink transparent body contains D&C Red No. 28 & gelatin. The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol and shellac. Meets USP Dissolution Test 2."
},
{
"NDCCode": "61919-463-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (61919-463-90) ",
"NDC11Code": "61919-0463-90",
"ProductNDC": "61919-463",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuorofen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190822",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091625",
"LabelerName": "Direct_Rx",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190822",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.",
"Description": "Ibuprofen tablets contain the active ingredient ibuprofen, which is (±)-2-(p-isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77° C and is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below: [ibuprofen-structure]. Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose 2910, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, povidone k-90, sodium lauryl sulphate, titanium dioxide."
},
{
"NDCCode": "63187-463-90",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (63187-463-90) ",
"NDC11Code": "63187-0463-90",
"ProductNDC": "63187-463",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Allopurinol",
"NonProprietaryName": "Allopurinol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090406",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018832",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "ALLOPURINOL",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230222",
"SamplePackage": "N",
"IndicationAndUsage": "THIS IS NOT AN INNOCUOUS DRUG. IT IS NOT RECOMMENDED FOR THE TREATMENT OF ASYMPTOMATIC HYPERURICEMIA. Allopurinol reduces serum and urinary uric acid concentrations. Its use should be individualized for each patient and requires an understanding of its mode of action and pharmacokinetics (see CLINICAL PHARMACOLOGY, CONTRAINDICATIONS, WARNINGS and PRECAUTIONS). Allopurinol is indicated in: 1 the management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy)., 2 the management of patients with leukemia, lymphoma and malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels. Allopurinol treatment should be discontinued when the potential for overproduction of uric acid is no longer present., 3 the management of patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients. Therapy in such patients should be carefully assessed initially and reassessed periodically to determine in each case that treatment is beneficial and that the benefits outweigh the risks.",
"Description": "Allopurinol is known chemically as 1,5-Dihydro-4H-pyrazolo[3,4-d ]pyrimidin-4-one. It is a xanthine oxidase inhibitor which is administered orally. Its solubility in water at 37°C is 80 mg/dL and is greater in an alkaline solution. The structural formula is represented below. C5H4N4O M.W. 136.11. Allopurinol Tablets USP, 100 mg and 300 mg contain the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium lauryl sulfate. Allopurinol Tablets USP, 300 mg also contain FD&C Yellow No. 6."
},
{
"NDCCode": "67877-463-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (67877-463-90) ",
"NDC11Code": "67877-0463-90",
"ProductNDC": "67877-463",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20191002",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207799",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191002",
"SamplePackage": "N",
"IndicationAndUsage": "Pregabalin is indicated for: Management of neuropathic pain associated with diabetic peripheral neuropathy Management of postherpetic neuralgia Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older Management of fibromyalgia Management of neuropathic pain associated with spinal cord injury.",
"Description": "Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch, and talc as inactive ingredients. The capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg) contain red iron oxide, yellow iron oxide. The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol and shellac."
},
{
"NDCCode": "71205-463-90",
"PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-463-90) ",
"NDC11Code": "71205-0463-90",
"ProductNDC": "71205-463",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tramadol Hydrochloride",
"NonProprietaryName": "Tramadol Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20140819",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200503",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "TRAMADOL HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2022-04-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200721",
"SamplePackage": "N",
"IndicationAndUsage": "Tramadol hydrochloride extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations [see Warnings and Precautions (5.1)] , reserve tramadol hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Tramadol hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic.",
"Description": "Tramadol hydrochloride is an opioid agonist in an extended-release tablet formulation for oral use. The chemical name is (±) cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular weight of tramadol HCl is 299.84. It is a white, bitter, crystalline and odorless powder that is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride extended-release tablets USP contain 100, 200 or 300 mg of tramadol HCl in an extended-release formulation. The tablets are white to off-white in color and contain the inactive ingredients: colloidal silicon dioxide, dibutyl sebacate, ethyl cellulose, microcrystalline cellulose, povidone, and sodium stearyl fumarate. The imprinting ink contains shellac, iron oxide black and propylene glycol. Tramadol hydrochloride extended-release tablets USP meet USP Dissolution Test 3."
},
{
"NDCCode": "71610-463-60",
"PackageDescription": "90 TABLET in 1 BOTTLE (71610-463-60) ",
"NDC11Code": "71610-0463-60",
"ProductNDC": "71610-463",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160204",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205101",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20201015",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin is indicated for: : 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy .",
"Description": "The active ingredient in gabapentin capsules and tablets, USP is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin, USP is a white to off-white crystalline solid with a pKa1 of 4.72±0.10 and a pKa2 of 10.27±0.29. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient is -1.083±0.235 at 25°C temperature. Each gabapentin capsule contains 100 mg, 300 mg or 400 mg of gabapentin, USP and the following inactive ingredients: pregelatinized starch (maize), and talc. The 100 mg capsule shell contains gelatin, sodium lauryl sulfate (SLS) and titanium dioxide. The 300 mg capsule shell contains gelatin, titanium dioxide, FD&C Red 40, D&C Yellow 10, and sodium lauryl sulfate (SLS). The 400mg capsule shell contains gelatin, titanium dioxide, sodium lauryl sulfate (SLS), D&C Yellow 10, and FD&C Red 40. The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, and potassium hydroxide. Each gabapentin tablet contains 600 mg or 800 mg of gabapentin, USP and the following inactive ingredients: poloxamer 407, mannitol, magnesium stearate, hydroxypropyl cellulose, talc, copovidone, crospovidone, colloidal silicon dioxide and coating agent contains hypromellose, titanium dioxide, polyethylene glycol and talc."
},
{
"NDCCode": "72789-008-90",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (72789-008-90) ",
"NDC11Code": "72789-0008-90",
"ProductNDC": "72789-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Anastrozole",
"NonProprietaryName": "Anastrozole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100622",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090568",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "ANASTROZOLE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aromatase Inhibitor [EPC], Aromatase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200306",
"SamplePackage": "N",
"IndicationAndUsage": "Anastrozole is an aromatase inhibitor indicated for: 1 Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer ( 1.1) , 2 First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer ( 1.2) , 3 Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to anastrozole ( 1.3) .",
"Description": "Anastrozole tablets, USP for oral administration contain 1 mg of anastrozole, a non-steroidal aromatase inhibitor. It is chemically described as 1,3-Benzenediacetonitrile, a, a, a', a'-tetramethyl-5-(1H-1,2,4-triazol-1-ylmethyl). Its molecular formula is C 17H 19N 5and its structural formula is:. Anastrozole is an off-white powder with a molecular weight of 293.4. Anastrozole has moderate aqueous solubility (0.5 mg/mL at 25°C); solubility is independent of pH in the physiological range. Anastrozole is freely soluble in methanol, acetone, ethanol, and tetrahydrofuran, and very soluble in acetonitrile. Each tablet contains as inactive ingredients: lactose monohydrate, magnesium stearate, hypromellose, macrogol, povidone, sodium starch glycolate, and titanium dioxide."
},
{
"NDCCode": "72789-009-90",
"PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-009-90) ",
"NDC11Code": "72789-0009-90",
"ProductNDC": "72789-009",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride Extended Release",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160512",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090295",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190913",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin Hydrochloride Extended-Release Tablets, USP is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Metformin Hydrochloride Extended-Release Tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride.The chemical name of Metformin hydrochloride is N, N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below:. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5 HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pK aof metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin Hydrochloride Extended-Release Tablets, USP contain 500 mg or 750 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 584.90 mg metformin base, respectively. Metformin Hydrochloride Extended-Release Tablets, 500 mg or 750 mg contains the inactive ingredients colloidal silicon dioxide, hypromellose and magnesium stearate."
},
{
"NDCCode": "72789-013-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-013-90) ",
"NDC11Code": "72789-0013-90",
"ProductNDC": "72789-013",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077206",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190924",
"SamplePackage": "N",
"IndicationAndUsage": "Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)] :.",
"Description": "Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NCl 2HCl is represented by the following structural formula: Sertraline hydrochloride USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloridetablets USPare supplied for oral administration as scored tablets contain 28 mg, 56 mg and 112 mg sertraline hydrochloride USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, hydroxypropyl cellulose, dibasic calcium phosphate dihydrate, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and polysorbate 80. Besides, 25 mg contains D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake; 50 mg contains FD&C blue #2 aluminum lake; and 100 mg contains iron oxide yellow. Meets USP dissolution test 3."
},
{
"NDCCode": "72789-019-90",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (72789-019-90) ",
"NDC11Code": "72789-0019-90",
"ProductNDC": "72789-019",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carisoprodol",
"NonProprietaryName": "Carisoprodol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190808",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040245",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "CARISOPRODOL",
"StrengthNumber": "350",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2024-10-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20191024",
"SamplePackage": "N",
"IndicationAndUsage": "Carisoprodol Tablets USP are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Carisoprodol Tablets USP should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [ see Dosage and Administration (2)].",
"Description": "Carisoprodol Tablets USP are available as 350 mg round, white tablets for oral administration. Carisoprodol is a white, crystalline powder, having a mild, characteristic odor and a bitter taste. It is slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone; and its solubility is practically independent of pH. Carisoprodol is present as a racemic mixture. Chemically, carisoprodol is N-isopropyl-2-methyl-2-propyl-1,3-propanediol dicarbamate and the molecular formula is C 12H 24N 2O 4, with a molecular weight of 260.33. The structural formula is:. Other ingredients in Carisoprodol Tablets, USP include croscarmellose sodium, hydrogenated vegetable oil, hypromellose, magnesium stearate and microcrystalline cellulose."
},
{
"NDCCode": "72789-021-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-021-90) ",
"NDC11Code": "72789-0021-90",
"ProductNDC": "72789-021",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
"NonProprietaryName": "Methocarbamol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208507",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "METHOCARBAMOL",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230912",
"SamplePackage": "N",
"IndicationAndUsage": "Methocarbamol Tablets USP, 500 mg and 750 mg are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.",
"Description": "Methocarbamol Tablets USP, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 3 - (2-methoxyphenoxy) -1, 2- propanediol 1-carbamate and has the empirical formula C 11H 15NO 5. Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Methocarbamol Tablets USP, 500 mg is available as a light orange colored, round, film-coated tablets, engraved with 'B134' on one side and scored on the other side, containing 500 mg of methocarbamol, USP for oral administration. The inactive ingredients present are corn starch, low substituted hydroxypropyl cellulose, hydroxyprolyl cellulose, sodium starch glycolate, povidone, sodium lauryl sulfate, colloidal silicon dioxide, stearic acid, magnesium stearate, and purified water. Methocarbamol Tablets USP, 500 mg contains Opadry 13H530000 (Orange) (hypromellose, titanium dioxide, propylene glycol, FD&C yellow #6/Sunset Yellow FCF Aluminum Lake, polysorbate 20) as coating material. Methocarbamol Tablets USP, 750 mg is available as an orange colored, capsule shaped, film coated tablets, engraved with 'B135' on one side and plain on the other side, containing 750 mg of methocarbamol, USP for oral administration. It contains Opadry 13H530001 (Orange) as coating material. The inactive ingredients present are corn starch, low substituted hydroxypropyl cellulose, hydroxyprolyl cellulose, sodium starch glycolate, povidone, sodium lauryl sulfate, colloidal silicon dioxide, stearic acid, magnesium stearate, and purified water. Methocarbamol Tablets USP, 750 mg contain Opadry 13H530001 (Orange) (hypromellose, titanium dioxide, propylene glycol, D&C Yellow #10 Aluminum Lake, FD&C yellow #6/Sunset Yellow FCC Aluminum Lake, polysorbate 20) as coating material."
},
{
"NDCCode": "72789-022-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-022-90) ",
"NDC11Code": "72789-0022-90",
"ProductNDC": "72789-022",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
"NonProprietaryName": "Methocarbamol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208507",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "METHOCARBAMOL",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230912",
"SamplePackage": "N",
"IndicationAndUsage": "Methocarbamol Tablets USP, 500 mg and 750 mg are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.",
"Description": "Methocarbamol Tablets USP, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 3 - (2-methoxyphenoxy) -1, 2- propanediol 1-carbamate and has the empirical formula C 11H 15NO 5. Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Methocarbamol Tablets USP, 500 mg is available as a light orange colored, round, film-coated tablets, engraved with 'B134' on one side and scored on the other side, containing 500 mg of methocarbamol, USP for oral administration. The inactive ingredients present are corn starch, low substituted hydroxypropyl cellulose, hydroxyprolyl cellulose, sodium starch glycolate, povidone, sodium lauryl sulfate, colloidal silicon dioxide, stearic acid, magnesium stearate, and purified water. Methocarbamol Tablets USP, 500 mg contains Opadry 13H530000 (Orange) (hypromellose, titanium dioxide, propylene glycol, FD&C yellow #6/Sunset Yellow FCF Aluminum Lake, polysorbate 20) as coating material. Methocarbamol Tablets USP, 750 mg is available as an orange colored, capsule shaped, film coated tablets, engraved with 'B135' on one side and plain on the other side, containing 750 mg of methocarbamol, USP for oral administration. It contains Opadry 13H530001 (Orange) as coating material. The inactive ingredients present are corn starch, low substituted hydroxypropyl cellulose, hydroxyprolyl cellulose, sodium starch glycolate, povidone, sodium lauryl sulfate, colloidal silicon dioxide, stearic acid, magnesium stearate, and purified water. Methocarbamol Tablets USP, 750 mg contain Opadry 13H530001 (Orange) (hypromellose, titanium dioxide, propylene glycol, D&C Yellow #10 Aluminum Lake, FD&C yellow #6/Sunset Yellow FCC Aluminum Lake, polysorbate 20) as coating material."
},
{
"NDCCode": "72789-024-90",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (72789-024-90) ",
"NDC11Code": "72789-0024-90",
"ProductNDC": "72789-024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alprazolam",
"NonProprietaryName": "Alprazolam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180709",
"EndMarketingDate": "20251031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207507",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "ALPRAZOLAM",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20191031",
"EndMarketingDatePackage": "20251031",
"SamplePackage": "N",
"IndicationAndUsage": "Alprazolam tablets are indicated for the: 1 acute treatment of generalized anxiety disorder (GAD) in adults., 2 treatment of panic disorder (PD), with or without agoraphobia in adults.",
"Description": "Alprazolam Tablets, USP, contain alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The structural formula is. Alprazolam is a white crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. Each Alprazolam tablet, USP, for oral administration, contains 0.25 mg, 0.5 mg, 1 mg, or 2 mg of alprazolam. Alprazolam Tablets, USP, 2 mg, are multi-scored and may be divided as shown below. Inactive ingredients: Lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, hydroxyl propyl cellulose, sodium lauryl sulfate and magnesium stearate. In addition, the 0.5 mg tablet contains FD&C Yellow 6 lake and the 1 mg and 2 mg tablets contain FD&C Blue 2 lake."
},
{
"NDCCode": "72789-029-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-029-90) ",
"NDC11Code": "72789-0029-90",
"ProductNDC": "72789-029",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Losartan Potassium",
"NonProprietaryName": "Losartan Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150819",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203835",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "LOSARTAN POTASSIUM",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191120",
"SamplePackage": "N",
"IndicationAndUsage": "Losartan Potassium tablets are an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. ( 1.2) Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. ( 1.3).",
"Description": "Losartan potassium is an angiotensin II receptor blocker acting on the AT 1receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-l-[(2'-(lH-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-lH-imidazole-5-methanol mono potassium salt. Its molecular formula is C 22H 22ClKN 6O, and its structural formula is:. Losartan potassium, USP is a white to off-white powder with a molecular weight of 461.01. It is freely soluble in water and slightly soluble in acetonitrile. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium, USP and the following inactive ingredients: crospovidone, lactose monohydrate, low substituted hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose and pregelatinized starch. The tablets are coated with Opadry White which contains carnauba wax, hypromellose and titanium dioxide. Losartan potassium tablets USP, 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively. The botanical source for pregelatinized starch is corn starch."
},
{
"NDCCode": "72789-031-90",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (72789-031-90) ",
"NDC11Code": "72789-0031-90",
"ProductNDC": "72789-031",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enalapril Maleate",
"NonProprietaryName": "Enalapril Maleate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19851224",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA018998",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "ENALAPRIL MALEATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]",
"Status": "Deprecated",
"LastUpdate": "2022-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20191121",
"SamplePackage": "N"
},
{
"NDCCode": "72789-036-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-90) ",
"NDC11Code": "72789-0036-90",
"ProductNDC": "72789-036",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170330",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077797",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200225",
"SamplePackage": "N",
"IndicationAndUsage": "Cyclobenzaprine hydrochloride tablets are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
"Description": "Cyclobenzaprine hydrochloride is a white, crystalline tricyclic amine salt with the empirical formula C 20H 21N HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pK aof 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl is designated chemically as 3-( 5H-dibenzo[ a,d]cyclohepten-5-ylidene)- N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula:. Cyclobenzaprine Hydrochloride Tablets, USP are supplied as 5 mg and 10 mg tablets for oral administration. Each tablet contains the following inactive ingredients: croscarmellose sodium, FD&C Yellow #6, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide; 5 mg tablets also contain FD&C Red #40 and 10 mg tablets contain D&C Yellow #10 and polysorbate."
},
{
"NDCCode": "72789-044-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-044-90) ",
"NDC11Code": "72789-0044-90",
"ProductNDC": "72789-044",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Losartan Potassium",
"NonProprietaryName": "Losartan Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150819",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203835",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "LOSARTAN POTASSIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200205",
"SamplePackage": "N",
"IndicationAndUsage": "Losartan Potassium tablets are an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. ( 1.2) Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. ( 1.3).",
"Description": "Losartan potassium is an angiotensin II receptor blocker acting on the AT 1receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-l-[(2'-(lH-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-lH-imidazole-5-methanol mono potassium salt. Its molecular formula is C 22H 22ClKN 6O, and its structural formula is:. Losartan potassium, USP is a white to off-white powder with a molecular weight of 461.01. It is freely soluble in water and slightly soluble in acetonitrile. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium, USP and the following inactive ingredients: crospovidone, lactose monohydrate, low substituted hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose and pregelatinized starch. The tablets are coated with Opadry White which contains carnauba wax, hypromellose and titanium dioxide. Losartan potassium tablets USP, 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively. The botanical source for pregelatinized starch is corn starch."
},
{
"NDCCode": "72789-049-90",
"PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-049-90) ",
"NDC11Code": "72789-0049-90",
"ProductNDC": "72789-049",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxybutynin Chloride",
"NonProprietaryName": "Oxybutynin Chloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20161220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207138",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "OXYBUTYNIN CHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200128",
"SamplePackage": "N",
"IndicationAndUsage": "Oxybutynin chloride extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. Oxybutynin chloride extended-release tablets are also indicated for the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida).",
"Description": "Oxybutynin chloride extended-release tablet, USP is an antispasmodic, muscarinic antagonist. Each oxybutynin chloride extended-release tablet, USP contains 5 mg, 10 mg, or 15 mg of oxybutynin chloride USP, formulated as a once-a-day controlled-release tablet for oral administration. Oxybutynin chloride is administered as a racemate of R- and S-enantiomers. Chemically, oxybutynin chloride is d,l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochloride. The empirical formula of oxybutynin chloride is C 22H 31NO 3HCl. Its structural formula is. Oxybutynin chloride is a white crystalline solid with a molecular weight of 393.9. It is readily soluble in water and acids, but relatively insoluble in alkalis. Oxybutynin chloride extended-release tablets, USP contains the following inert ingredients: colloidal anhydrous silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer type-c, microcrystalline cellulose, polyethylene glycol, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. Coloring agents are ferric oxide yellow (in all strengths), ferric oxide red (in 5 mg and 10 mg only) and ferric oxide black (in 15 mg only). System Components and Performance. Oxybutynin chloride extended-release tablets, USP are formulated to deliver oxybutynin chloride at a controlled rate over approximately 24 hours. The dosage form is comprised of a hydrophilic cellulose polymer matrix tablet surrounded by an enteric coating system. The enteric coat is insoluble in the low pH environment of the stomach. As the tablet passes through the stomach and enters the higher pH environment of the small intestine, the enteric coating dissolves and/or erodes to expose the polymer matrix tablet which swells and releases drug at a controlled rate via diffusion and/or erosion. Oxybutynin chloride extended-release tablets, USP meets USP dissolution test 5."
},
{
"NDCCode": "72789-050-90",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (72789-050-90) ",
"NDC11Code": "72789-0050-90",
"ProductNDC": "72789-050",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levothyroxine Sodium",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20071001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021210",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": ".137",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-08-19",
"PackageNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20200131",
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},
{
"NDCCode": "72789-055-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE, PLASTIC (72789-055-90) ",
"NDC11Code": "72789-0055-90",
"ProductNDC": "72789-055",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20140403",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075350",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-08-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20200224",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin capsules are indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.",
"Description": "The active ingredient in gabapentin capsules, USP is gabapentin, USP which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin, USP is C 9H 17NO 2and the molecular weight is 171.24. The structural formula of gabapentin, USP is:. Gabapentin, USP is a white to off-white crystalline solid with a pK a1of 3.7 and a pK a2of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.25. Each gabapentin capsule contains 100 mg, 300 mg, or 400 mg of gabapentin, USP and the following inactive ingredients: black iron oxide, corn starch, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, gelatin, mannitol, red iron oxide, shellac, talc, titanium dioxide, yellow iron oxide and may contain propylene glycol and sodium lauryl sulfate."
},
{
"NDCCode": "72789-059-90",
"PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-059-90) ",
"NDC11Code": "72789-0059-90",
"ProductNDC": "72789-059",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20080417",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078321",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-04-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200302",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Metformin hydrochloride extended-release tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below:. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5∙ HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pK aof metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride extended-release tablets, USP contain 500 mg or 750 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 584.90 mg metformin base, respectively. Metformin hydrochloride extended-release tablets USP, 500 mg and 750 mg contain the inactive ingredients carboxymethylcellulose sodium, copovidone, hypromellose, magnesium stearate and microcrystalline cellulose. The USP dissolution test is pending."
},
{
"NDCCode": "72789-060-90",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (72789-060-90) ",
"NDC11Code": "72789-0060-90",
"ProductNDC": "72789-060",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Armodafinil",
"NonProprietaryName": "Armodafinil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20161129",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021875",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "ARMODAFINIL",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2022-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20200416",
"SamplePackage": "N"
},
{
"NDCCode": "72789-070-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-070-90) ",
"NDC11Code": "72789-0070-90",
"ProductNDC": "72789-070",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20060117",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076143",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240607",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion hydrochloride tablets in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies ( 14)].",
"Description": "Bupropion hydrochloride, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.21 g/mol. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride powder is white to off-white crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion hydrochloride is supplied for oral administration as 75-mg (orange) and 100-mg (purple) film-coated tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the following inactive ingredients. 75-mg tablet –colloidal silicon dioxide, crospovidone, FD&C Yellow #6 Aluminum Lake, fumaric acid granular, hydroxypropyl cellulose, hypromellose, magnesium stearate, methylcellulose, polyethylene glycol and titanium dioxide. 100-mg tablet –colloidal silicon dioxide, crospovidone, D&C Red #7 Calcium Lake, fumaric acid granular, hydroxypropyl cellulose, hypromellose, magnesium stearate, methylcellulose, polyethylene glycol and titanium dioxide."
},
{
"NDCCode": "72789-071-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-071-90) ",
"NDC11Code": "72789-0071-90",
"ProductNDC": "72789-071",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Citalopram",
"NonProprietaryName": "Citalopram",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20071018",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078216",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "CITALOPRAM HYDROBROMIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N",
"IndicationAndUsage": "Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies ( 14)] .",
"Description": "Citalopram tablets, USP contain citalopram, a selective serotonin reuptake inhibitor (SSRI). Citalopram hydrobromide is a racemic bicyclic phthalane structure and is designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3dihydroisobenzofuran-5-carbonitrile hydrobromide with the following structural formula. The molecular formula is C 20H 22BrFN 2O and its molecular weight is 405.35. Citalopram hydrobromide, USP occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol. Citalopram, USP 10 mg tablets are film-coated, round shaped tablets containing citalopram hydrobromide in strengths equivalent to 10 mg citalopram base. Citalopram hydrobromide, USP 20 mg and 40 mg tablets are film-coated, oval shaped, scored tablets containing citalopram hydrobromide, in strengths equivalent to 20 mg or 40 mg citalopram base. The tablets also contain the following inactive ingredients: copovidone, corn starch, croscarmellose sodium, ferric oxide red, ferric oxide yellow, glycerin, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide."
},
{
"NDCCode": "72789-090-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE, PLASTIC (72789-090-90) ",
"NDC11Code": "72789-0090-90",
"ProductNDC": "72789-090",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Silodosin",
"NonProprietaryName": "Silodosin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20181203",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210687",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "SILODOSIN",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200623",
"SamplePackage": "N",
"IndicationAndUsage": "Silodosin capsule, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see CLINICAL STUDIES (14)]. Silodosin capsule is not indicated for the treatment of hypertension.",
"Description": "Silodosin capsules is the brand name for silodosin, a selective antagonist of alpha-1 adrenoreceptors. The chemical name of silodosin is 1-(3- Hydroxypropyl)-5-[(2R)-2-({2-[2-(2,2,2-trifluoroethoxy) phenoxy]ethyl} amino) propyl]-2,3-dihydro-1H-indole-7-carboxamide and the molecular formula is C 25H 32F 3N 3O 4 with a molecular weight of 495.53. The structural formula of silodosin is:. Silodosin is a white to pale yellowish white powder that melts at approximately 104.72 to 107.5 °C. It is freely soluble in acetic acid, and in absolute alcohol, and insoluble in water. Each Silodosin 8 mg capsule for oral administration contains 8 mg silodosin, and the following inactive ingredients: magnesium stearate, magnesium aluminometasilicate, mannitol, polysorbate 80 and pregelatinized starch. The size #1 hard gelatin capsules contain gelatin and titanium dioxide. The capsules are printed with edible ink containing shellac, propylene glycol, black iron oxide and potassium hydroxide. Each Silodosin 4 mg capsule for oral administration contains 4 mg silodosin, and the following inactive ingredients: magnesium stearate, magnesium aluminometasilicate, mannitol, polysorbate 80 and pregelatinized starch. The size #3 hard gelatin capsules contain gelatin and titanium dioxide. The capsules are printed with edible ink containing shellac, propylene glycol, black iron oxide and potassium hydroxide."
}
]
}
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<IndicationAndUsage>Glipizide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazine-carboxamido)ethyl]phenyl]sulfonyl]urea. The molecular formula is C 21H 27N 5O 4S; the molecular weight is 445.55; the structural formula is shown below:. Glipizide is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. Glipizide tablets for oral use are available in 2.5 mg, 5 mg, 10 mg and 15 mg strengths. Inactive ingredients are: colloidal silicon dioxide; croscarmellose sodium, lactose anhydrous; microcrystalline cellulose and stearic acid. Meets USP Dissolution test 2.</Description>
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<NDCCode>72789-463-60</NDCCode>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glipizide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazine-carboxamido)ethyl]phenyl]sulfonyl]urea. The molecular formula is C 21H 27N 5O 4S; the molecular weight is 445.55; the structural formula is shown below:. Glipizide is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. Glipizide tablets for oral use are available in 2.5 mg, 5 mg, 10 mg and 15 mg strengths. Inactive ingredients are: colloidal silicon dioxide; croscarmellose sodium, lactose anhydrous; microcrystalline cellulose and stearic acid. Meets USP Dissolution test 2.</Description>
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<IndicationAndUsage>Glipizide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glipizide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazine-carboxamido)ethyl]phenyl]sulfonyl]urea. The molecular formula is C 21H 27N 5O 4S; the molecular weight is 445.55; the structural formula is shown below:. Glipizide is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. Glipizide tablets for oral use are available in 2.5 mg, 5 mg, 10 mg and 15 mg strengths. Inactive ingredients are: colloidal silicon dioxide; croscarmellose sodium, lactose anhydrous; microcrystalline cellulose and stearic acid. Meets USP Dissolution test 2.</Description>
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<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>GLIPIZIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfonylurea Compounds [CS], Sulfonylurea [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glipizide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazine-carboxamido)ethyl]phenyl]sulfonyl]urea. The molecular formula is C 21H 27N 5O 4S; the molecular weight is 445.55; the structural formula is shown below:. Glipizide is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. Glipizide tablets for oral use are available in 2.5 mg, 5 mg, 10 mg and 15 mg strengths. Inactive ingredients are: colloidal silicon dioxide; croscarmellose sodium, lactose anhydrous; microcrystalline cellulose and stearic acid. Meets USP Dissolution test 2.</Description>
</NDC>
<NDC>
<NDCCode>13668-463-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (13668-463-90) </PackageDescription>
<NDC11Code>13668-0463-90</NDC11Code>
<ProductNDC>13668-463</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Itraconazole</ProprietaryName>
<NonProprietaryName>Itraconazole</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180824</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209460</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>ITRACONAZOLE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180824</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Itraconazole capsules are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients: 1 Blastomycosis, pulmonary and extrapulmonary, 2 Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis, and, 3 Aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy.</IndicationAndUsage>
<Description>Itraconazole, USP is an azole antifungal agent. Itraconazole is a 1:1:1:1 racemic mixture of four diastereomers (two enantiomeric pairs), each possessing three chiral centers. It may be represented by the following structural formula and nomenclature. 3H-1,2,4-Triazol-3-one,4-[4-[4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-2-4-dihydro-2-(1-methylpropyl)-. or. (±)-1-sec-Butyl-4-[p-[4-[p-[[(2R*,4S*)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-Δ2-1,2,4-triazolin-5-one. Itraconazole USP has a molecular formula of C35H38Cl2N8O4 and a molecular weight of 705.63. It is a white or almost white powder. It is practically insoluble in water, very slightly soluble in alcohol, freely soluble in methylene chloride, and sparingly soluble in tetrahydrofuran. It has a pKa of 3.7* (*Merck Index, Fifteenth Edition) and a log (n-octanol/water) partition coefficient of 5.66 at pH 8.1. Itraconazole capsules, USP contain 100 mg of itraconazole, USP coated on sugar spheres (composed of maize starch and sucrose). Inactive ingredients are hard gelatin capsule, hypromellose, polyethylene glycol, sugar spheres & talc. In addition, the blue opaque capsule shell contains FD&C Blue No. 1, FD&C Blue No. 2, gelatin & titanium dioxide and the pink transparent body contains D&C Red No. 28 & gelatin. The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol and shellac. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>61919-463-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (61919-463-90) </PackageDescription>
<NDC11Code>61919-0463-90</NDC11Code>
<ProductNDC>61919-463</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuorofen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190822</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091625</ApplicationNumber>
<LabelerName>Direct_Rx</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190822</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.</IndicationAndUsage>
<Description>Ibuprofen tablets contain the active ingredient ibuprofen, which is (±)-2-(p-isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77° C and is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below: [ibuprofen-structure]. Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose 2910, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, povidone k-90, sodium lauryl sulphate, titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>63187-463-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (63187-463-90) </PackageDescription>
<NDC11Code>63187-0463-90</NDC11Code>
<ProductNDC>63187-463</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Allopurinol</ProprietaryName>
<NonProprietaryName>Allopurinol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090406</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018832</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>ALLOPURINOL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>THIS IS NOT AN INNOCUOUS DRUG. IT IS NOT RECOMMENDED FOR THE TREATMENT OF ASYMPTOMATIC HYPERURICEMIA. Allopurinol reduces serum and urinary uric acid concentrations. Its use should be individualized for each patient and requires an understanding of its mode of action and pharmacokinetics (see CLINICAL PHARMACOLOGY, CONTRAINDICATIONS, WARNINGS and PRECAUTIONS). Allopurinol is indicated in: 1 the management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy)., 2 the management of patients with leukemia, lymphoma and malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels. Allopurinol treatment should be discontinued when the potential for overproduction of uric acid is no longer present., 3 the management of patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients. Therapy in such patients should be carefully assessed initially and reassessed periodically to determine in each case that treatment is beneficial and that the benefits outweigh the risks.</IndicationAndUsage>
<Description>Allopurinol is known chemically as 1,5-Dihydro-4H-pyrazolo[3,4-d ]pyrimidin-4-one. It is a xanthine oxidase inhibitor which is administered orally. Its solubility in water at 37°C is 80 mg/dL and is greater in an alkaline solution. The structural formula is represented below. C5H4N4O M.W. 136.11. Allopurinol Tablets USP, 100 mg and 300 mg contain the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium lauryl sulfate. Allopurinol Tablets USP, 300 mg also contain FD&C Yellow No. 6.</Description>
</NDC>
<NDC>
<NDCCode>67877-463-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (67877-463-90) </PackageDescription>
<NDC11Code>67877-0463-90</NDC11Code>
<ProductNDC>67877-463</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191002</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207799</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191002</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pregabalin is indicated for: Management of neuropathic pain associated with diabetic peripheral neuropathy Management of postherpetic neuralgia Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older Management of fibromyalgia Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
<Description>Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch, and talc as inactive ingredients. The capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg) contain red iron oxide, yellow iron oxide. The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol and shellac.</Description>
</NDC>
<NDC>
<NDCCode>71205-463-90</NDCCode>
<PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-463-90) </PackageDescription>
<NDC11Code>71205-0463-90</NDC11Code>
<ProductNDC>71205-463</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
<NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140819</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200503</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>TRAMADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2022-04-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200721</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tramadol hydrochloride extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations [see Warnings and Precautions (5.1)] , reserve tramadol hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Tramadol hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
<Description>Tramadol hydrochloride is an opioid agonist in an extended-release tablet formulation for oral use. The chemical name is (±) cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular weight of tramadol HCl is 299.84. It is a white, bitter, crystalline and odorless powder that is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride extended-release tablets USP contain 100, 200 or 300 mg of tramadol HCl in an extended-release formulation. The tablets are white to off-white in color and contain the inactive ingredients: colloidal silicon dioxide, dibutyl sebacate, ethyl cellulose, microcrystalline cellulose, povidone, and sodium stearyl fumarate. The imprinting ink contains shellac, iron oxide black and propylene glycol. Tramadol hydrochloride extended-release tablets USP meet USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>71610-463-60</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (71610-463-60) </PackageDescription>
<NDC11Code>71610-0463-60</NDC11Code>
<ProductNDC>71610-463</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160204</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205101</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201015</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin is indicated for: : 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy .</IndicationAndUsage>
<Description>The active ingredient in gabapentin capsules and tablets, USP is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin, USP is a white to off-white crystalline solid with a pKa1 of 4.72±0.10 and a pKa2 of 10.27±0.29. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient is -1.083±0.235 at 25°C temperature. Each gabapentin capsule contains 100 mg, 300 mg or 400 mg of gabapentin, USP and the following inactive ingredients: pregelatinized starch (maize), and talc. The 100 mg capsule shell contains gelatin, sodium lauryl sulfate (SLS) and titanium dioxide. The 300 mg capsule shell contains gelatin, titanium dioxide, FD&C Red 40, D&C Yellow 10, and sodium lauryl sulfate (SLS). The 400mg capsule shell contains gelatin, titanium dioxide, sodium lauryl sulfate (SLS), D&C Yellow 10, and FD&C Red 40. The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, and potassium hydroxide. Each gabapentin tablet contains 600 mg or 800 mg of gabapentin, USP and the following inactive ingredients: poloxamer 407, mannitol, magnesium stearate, hydroxypropyl cellulose, talc, copovidone, crospovidone, colloidal silicon dioxide and coating agent contains hypromellose, titanium dioxide, polyethylene glycol and talc.</Description>
</NDC>
<NDC>
<NDCCode>72789-008-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (72789-008-90) </PackageDescription>
<NDC11Code>72789-0008-90</NDC11Code>
<ProductNDC>72789-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Anastrozole</ProprietaryName>
<NonProprietaryName>Anastrozole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100622</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090568</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ANASTROZOLE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aromatase Inhibitor [EPC], Aromatase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200306</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Anastrozole is an aromatase inhibitor indicated for: 1 Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer ( 1.1) , 2 First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer ( 1.2) , 3 Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to anastrozole ( 1.3) .</IndicationAndUsage>
<Description>Anastrozole tablets, USP for oral administration contain 1 mg of anastrozole, a non-steroidal aromatase inhibitor. It is chemically described as 1,3-Benzenediacetonitrile, a, a, a', a'-tetramethyl-5-(1H-1,2,4-triazol-1-ylmethyl). Its molecular formula is C 17H 19N 5and its structural formula is:. Anastrozole is an off-white powder with a molecular weight of 293.4. Anastrozole has moderate aqueous solubility (0.5 mg/mL at 25°C); solubility is independent of pH in the physiological range. Anastrozole is freely soluble in methanol, acetone, ethanol, and tetrahydrofuran, and very soluble in acetonitrile. Each tablet contains as inactive ingredients: lactose monohydrate, magnesium stearate, hypromellose, macrogol, povidone, sodium starch glycolate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>72789-009-90</NDCCode>
<PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-009-90) </PackageDescription>
<NDC11Code>72789-0009-90</NDC11Code>
<ProductNDC>72789-009</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride Extended Release</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160512</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090295</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190913</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin Hydrochloride Extended-Release Tablets, USP is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin Hydrochloride Extended-Release Tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride.The chemical name of Metformin hydrochloride is N, N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below:. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5 HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pK aof metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin Hydrochloride Extended-Release Tablets, USP contain 500 mg or 750 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 584.90 mg metformin base, respectively. Metformin Hydrochloride Extended-Release Tablets, 500 mg or 750 mg contains the inactive ingredients colloidal silicon dioxide, hypromellose and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>72789-013-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-013-90) </PackageDescription>
<NDC11Code>72789-0013-90</NDC11Code>
<ProductNDC>72789-013</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077206</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190924</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)] :.</IndicationAndUsage>
<Description>Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NCl 2HCl is represented by the following structural formula: Sertraline hydrochloride USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloridetablets USPare supplied for oral administration as scored tablets contain 28 mg, 56 mg and 112 mg sertraline hydrochloride USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, hydroxypropyl cellulose, dibasic calcium phosphate dihydrate, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and polysorbate 80. Besides, 25 mg contains D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake; 50 mg contains FD&C blue #2 aluminum lake; and 100 mg contains iron oxide yellow. Meets USP dissolution test 3.</Description>
</NDC>
<NDC>
<NDCCode>72789-019-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (72789-019-90) </PackageDescription>
<NDC11Code>72789-0019-90</NDC11Code>
<ProductNDC>72789-019</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carisoprodol</ProprietaryName>
<NonProprietaryName>Carisoprodol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190808</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040245</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CARISOPRODOL</SubstanceName>
<StrengthNumber>350</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-10-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191024</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carisoprodol Tablets USP are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Carisoprodol Tablets USP should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [ see Dosage and Administration (2)].</IndicationAndUsage>
<Description>Carisoprodol Tablets USP are available as 350 mg round, white tablets for oral administration. Carisoprodol is a white, crystalline powder, having a mild, characteristic odor and a bitter taste. It is slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone; and its solubility is practically independent of pH. Carisoprodol is present as a racemic mixture. Chemically, carisoprodol is N-isopropyl-2-methyl-2-propyl-1,3-propanediol dicarbamate and the molecular formula is C 12H 24N 2O 4, with a molecular weight of 260.33. The structural formula is:. Other ingredients in Carisoprodol Tablets, USP include croscarmellose sodium, hydrogenated vegetable oil, hypromellose, magnesium stearate and microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>72789-021-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-021-90) </PackageDescription>
<NDC11Code>72789-0021-90</NDC11Code>
<ProductNDC>72789-021</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208507</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METHOCARBAMOL</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230912</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methocarbamol Tablets USP, 500 mg and 750 mg are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.</IndicationAndUsage>
<Description>Methocarbamol Tablets USP, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 3 - (2-methoxyphenoxy) -1, 2- propanediol 1-carbamate and has the empirical formula C 11H 15NO 5. Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Methocarbamol Tablets USP, 500 mg is available as a light orange colored, round, film-coated tablets, engraved with 'B134' on one side and scored on the other side, containing 500 mg of methocarbamol, USP for oral administration. The inactive ingredients present are corn starch, low substituted hydroxypropyl cellulose, hydroxyprolyl cellulose, sodium starch glycolate, povidone, sodium lauryl sulfate, colloidal silicon dioxide, stearic acid, magnesium stearate, and purified water. Methocarbamol Tablets USP, 500 mg contains Opadry 13H530000 (Orange) (hypromellose, titanium dioxide, propylene glycol, FD&C yellow #6/Sunset Yellow FCF Aluminum Lake, polysorbate 20) as coating material. Methocarbamol Tablets USP, 750 mg is available as an orange colored, capsule shaped, film coated tablets, engraved with 'B135' on one side and plain on the other side, containing 750 mg of methocarbamol, USP for oral administration. It contains Opadry 13H530001 (Orange) as coating material. The inactive ingredients present are corn starch, low substituted hydroxypropyl cellulose, hydroxyprolyl cellulose, sodium starch glycolate, povidone, sodium lauryl sulfate, colloidal silicon dioxide, stearic acid, magnesium stearate, and purified water. Methocarbamol Tablets USP, 750 mg contain Opadry 13H530001 (Orange) (hypromellose, titanium dioxide, propylene glycol, D&C Yellow #10 Aluminum Lake, FD&C yellow #6/Sunset Yellow FCC Aluminum Lake, polysorbate 20) as coating material.</Description>
</NDC>
<NDC>
<NDCCode>72789-022-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-022-90) </PackageDescription>
<NDC11Code>72789-0022-90</NDC11Code>
<ProductNDC>72789-022</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208507</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METHOCARBAMOL</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230912</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methocarbamol Tablets USP, 500 mg and 750 mg are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.</IndicationAndUsage>
<Description>Methocarbamol Tablets USP, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 3 - (2-methoxyphenoxy) -1, 2- propanediol 1-carbamate and has the empirical formula C 11H 15NO 5. Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Methocarbamol Tablets USP, 500 mg is available as a light orange colored, round, film-coated tablets, engraved with 'B134' on one side and scored on the other side, containing 500 mg of methocarbamol, USP for oral administration. The inactive ingredients present are corn starch, low substituted hydroxypropyl cellulose, hydroxyprolyl cellulose, sodium starch glycolate, povidone, sodium lauryl sulfate, colloidal silicon dioxide, stearic acid, magnesium stearate, and purified water. Methocarbamol Tablets USP, 500 mg contains Opadry 13H530000 (Orange) (hypromellose, titanium dioxide, propylene glycol, FD&C yellow #6/Sunset Yellow FCF Aluminum Lake, polysorbate 20) as coating material. Methocarbamol Tablets USP, 750 mg is available as an orange colored, capsule shaped, film coated tablets, engraved with 'B135' on one side and plain on the other side, containing 750 mg of methocarbamol, USP for oral administration. It contains Opadry 13H530001 (Orange) as coating material. The inactive ingredients present are corn starch, low substituted hydroxypropyl cellulose, hydroxyprolyl cellulose, sodium starch glycolate, povidone, sodium lauryl sulfate, colloidal silicon dioxide, stearic acid, magnesium stearate, and purified water. Methocarbamol Tablets USP, 750 mg contain Opadry 13H530001 (Orange) (hypromellose, titanium dioxide, propylene glycol, D&C Yellow #10 Aluminum Lake, FD&C yellow #6/Sunset Yellow FCC Aluminum Lake, polysorbate 20) as coating material.</Description>
</NDC>
<NDC>
<NDCCode>72789-024-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (72789-024-90) </PackageDescription>
<NDC11Code>72789-0024-90</NDC11Code>
<ProductNDC>72789-024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alprazolam</ProprietaryName>
<NonProprietaryName>Alprazolam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180709</StartMarketingDate>
<EndMarketingDate>20251031</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207507</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ALPRAZOLAM</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20191031</StartMarketingDatePackage>
<EndMarketingDatePackage>20251031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alprazolam tablets are indicated for the: 1 acute treatment of generalized anxiety disorder (GAD) in adults., 2 treatment of panic disorder (PD), with or without agoraphobia in adults.</IndicationAndUsage>
<Description>Alprazolam Tablets, USP, contain alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The structural formula is. Alprazolam is a white crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. Each Alprazolam tablet, USP, for oral administration, contains 0.25 mg, 0.5 mg, 1 mg, or 2 mg of alprazolam. Alprazolam Tablets, USP, 2 mg, are multi-scored and may be divided as shown below. Inactive ingredients: Lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, hydroxyl propyl cellulose, sodium lauryl sulfate and magnesium stearate. In addition, the 0.5 mg tablet contains FD&C Yellow 6 lake and the 1 mg and 2 mg tablets contain FD&C Blue 2 lake.</Description>
</NDC>
<NDC>
<NDCCode>72789-029-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-029-90) </PackageDescription>
<NDC11Code>72789-0029-90</NDC11Code>
<ProductNDC>72789-029</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Losartan Potassium</ProprietaryName>
<NonProprietaryName>Losartan Potassium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150819</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203835</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LOSARTAN POTASSIUM</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Losartan Potassium tablets are an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. ( 1.2) Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. ( 1.3).</IndicationAndUsage>
<Description>Losartan potassium is an angiotensin II receptor blocker acting on the AT 1receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-l-[(2'-(lH-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-lH-imidazole-5-methanol mono potassium salt. Its molecular formula is C 22H 22ClKN 6O, and its structural formula is:. Losartan potassium, USP is a white to off-white powder with a molecular weight of 461.01. It is freely soluble in water and slightly soluble in acetonitrile. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium, USP and the following inactive ingredients: crospovidone, lactose monohydrate, low substituted hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose and pregelatinized starch. The tablets are coated with Opadry White which contains carnauba wax, hypromellose and titanium dioxide. Losartan potassium tablets USP, 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively. The botanical source for pregelatinized starch is corn starch.</Description>
</NDC>
<NDC>
<NDCCode>72789-031-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (72789-031-90) </PackageDescription>
<NDC11Code>72789-0031-90</NDC11Code>
<ProductNDC>72789-031</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Enalapril Maleate</ProprietaryName>
<NonProprietaryName>Enalapril Maleate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19851224</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA018998</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ENALAPRIL MALEATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>72789-036-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-90) </PackageDescription>
<NDC11Code>72789-0036-90</NDC11Code>
<ProductNDC>72789-036</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170330</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077797</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200225</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyclobenzaprine hydrochloride tablets are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
<Description>Cyclobenzaprine hydrochloride is a white, crystalline tricyclic amine salt with the empirical formula C 20H 21N HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pK aof 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl is designated chemically as 3-( 5H-dibenzo[ a,d]cyclohepten-5-ylidene)- N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula:. Cyclobenzaprine Hydrochloride Tablets, USP are supplied as 5 mg and 10 mg tablets for oral administration. Each tablet contains the following inactive ingredients: croscarmellose sodium, FD&C Yellow #6, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide; 5 mg tablets also contain FD&C Red #40 and 10 mg tablets contain D&C Yellow #10 and polysorbate.</Description>
</NDC>
<NDC>
<NDCCode>72789-044-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-044-90) </PackageDescription>
<NDC11Code>72789-0044-90</NDC11Code>
<ProductNDC>72789-044</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Losartan Potassium</ProprietaryName>
<NonProprietaryName>Losartan Potassium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150819</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203835</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LOSARTAN POTASSIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Losartan Potassium tablets are an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. ( 1.2) Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. ( 1.3).</IndicationAndUsage>
<Description>Losartan potassium is an angiotensin II receptor blocker acting on the AT 1receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-l-[(2'-(lH-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-lH-imidazole-5-methanol mono potassium salt. Its molecular formula is C 22H 22ClKN 6O, and its structural formula is:. Losartan potassium, USP is a white to off-white powder with a molecular weight of 461.01. It is freely soluble in water and slightly soluble in acetonitrile. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium, USP and the following inactive ingredients: crospovidone, lactose monohydrate, low substituted hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose and pregelatinized starch. The tablets are coated with Opadry White which contains carnauba wax, hypromellose and titanium dioxide. Losartan potassium tablets USP, 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively. The botanical source for pregelatinized starch is corn starch.</Description>
</NDC>
<NDC>
<NDCCode>72789-049-90</NDCCode>
<PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-049-90) </PackageDescription>
<NDC11Code>72789-0049-90</NDC11Code>
<ProductNDC>72789-049</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxybutynin Chloride</ProprietaryName>
<NonProprietaryName>Oxybutynin Chloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207138</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>OXYBUTYNIN CHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxybutynin chloride extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. Oxybutynin chloride extended-release tablets are also indicated for the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida).</IndicationAndUsage>
<Description>Oxybutynin chloride extended-release tablet, USP is an antispasmodic, muscarinic antagonist. Each oxybutynin chloride extended-release tablet, USP contains 5 mg, 10 mg, or 15 mg of oxybutynin chloride USP, formulated as a once-a-day controlled-release tablet for oral administration. Oxybutynin chloride is administered as a racemate of R- and S-enantiomers. Chemically, oxybutynin chloride is d,l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochloride. The empirical formula of oxybutynin chloride is C 22H 31NO 3HCl. Its structural formula is. Oxybutynin chloride is a white crystalline solid with a molecular weight of 393.9. It is readily soluble in water and acids, but relatively insoluble in alkalis. Oxybutynin chloride extended-release tablets, USP contains the following inert ingredients: colloidal anhydrous silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer type-c, microcrystalline cellulose, polyethylene glycol, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. Coloring agents are ferric oxide yellow (in all strengths), ferric oxide red (in 5 mg and 10 mg only) and ferric oxide black (in 15 mg only). System Components and Performance. Oxybutynin chloride extended-release tablets, USP are formulated to deliver oxybutynin chloride at a controlled rate over approximately 24 hours. The dosage form is comprised of a hydrophilic cellulose polymer matrix tablet surrounded by an enteric coating system. The enteric coat is insoluble in the low pH environment of the stomach. As the tablet passes through the stomach and enters the higher pH environment of the small intestine, the enteric coating dissolves and/or erodes to expose the polymer matrix tablet which swells and releases drug at a controlled rate via diffusion and/or erosion. Oxybutynin chloride extended-release tablets, USP meets USP dissolution test 5.</Description>
</NDC>
<NDC>
<NDCCode>72789-050-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (72789-050-90) </PackageDescription>
<NDC11Code>72789-0050-90</NDC11Code>
<ProductNDC>72789-050</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levothyroxine Sodium</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071001</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021210</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>.137</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>72789-055-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE, PLASTIC (72789-055-90) </PackageDescription>
<NDC11Code>72789-0055-90</NDC11Code>
<ProductNDC>72789-055</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140403</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075350</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin capsules are indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.</IndicationAndUsage>
<Description>The active ingredient in gabapentin capsules, USP is gabapentin, USP which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin, USP is C 9H 17NO 2and the molecular weight is 171.24. The structural formula of gabapentin, USP is:. Gabapentin, USP is a white to off-white crystalline solid with a pK a1of 3.7 and a pK a2of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.25. Each gabapentin capsule contains 100 mg, 300 mg, or 400 mg of gabapentin, USP and the following inactive ingredients: black iron oxide, corn starch, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, gelatin, mannitol, red iron oxide, shellac, talc, titanium dioxide, yellow iron oxide and may contain propylene glycol and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>72789-059-90</NDCCode>
<PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-059-90) </PackageDescription>
<NDC11Code>72789-0059-90</NDC11Code>
<ProductNDC>72789-059</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080417</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078321</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200302</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin hydrochloride extended-release tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below:. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5∙ HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pK aof metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride extended-release tablets, USP contain 500 mg or 750 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 584.90 mg metformin base, respectively. Metformin hydrochloride extended-release tablets USP, 500 mg and 750 mg contain the inactive ingredients carboxymethylcellulose sodium, copovidone, hypromellose, magnesium stearate and microcrystalline cellulose. The USP dissolution test is pending.</Description>
</NDC>
<NDC>
<NDCCode>72789-060-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (72789-060-90) </PackageDescription>
<NDC11Code>72789-0060-90</NDC11Code>
<ProductNDC>72789-060</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Armodafinil</ProprietaryName>
<NonProprietaryName>Armodafinil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161129</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021875</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ARMODAFINIL</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2022-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200416</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>72789-070-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-070-90) </PackageDescription>
<NDC11Code>72789-0070-90</NDC11Code>
<ProductNDC>72789-070</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060117</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076143</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240607</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion hydrochloride tablets in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies ( 14)].</IndicationAndUsage>
<Description>Bupropion hydrochloride, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.21 g/mol. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride powder is white to off-white crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion hydrochloride is supplied for oral administration as 75-mg (orange) and 100-mg (purple) film-coated tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the following inactive ingredients. 75-mg tablet –colloidal silicon dioxide, crospovidone, FD&C Yellow #6 Aluminum Lake, fumaric acid granular, hydroxypropyl cellulose, hypromellose, magnesium stearate, methylcellulose, polyethylene glycol and titanium dioxide. 100-mg tablet –colloidal silicon dioxide, crospovidone, D&C Red #7 Calcium Lake, fumaric acid granular, hydroxypropyl cellulose, hypromellose, magnesium stearate, methylcellulose, polyethylene glycol and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>72789-071-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-071-90) </PackageDescription>
<NDC11Code>72789-0071-90</NDC11Code>
<ProductNDC>72789-071</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Citalopram</ProprietaryName>
<NonProprietaryName>Citalopram</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071018</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078216</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies ( 14)] .</IndicationAndUsage>
<Description>Citalopram tablets, USP contain citalopram, a selective serotonin reuptake inhibitor (SSRI). Citalopram hydrobromide is a racemic bicyclic phthalane structure and is designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3dihydroisobenzofuran-5-carbonitrile hydrobromide with the following structural formula. The molecular formula is C 20H 22BrFN 2O and its molecular weight is 405.35. Citalopram hydrobromide, USP occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol. Citalopram, USP 10 mg tablets are film-coated, round shaped tablets containing citalopram hydrobromide in strengths equivalent to 10 mg citalopram base. Citalopram hydrobromide, USP 20 mg and 40 mg tablets are film-coated, oval shaped, scored tablets containing citalopram hydrobromide, in strengths equivalent to 20 mg or 40 mg citalopram base. The tablets also contain the following inactive ingredients: copovidone, corn starch, croscarmellose sodium, ferric oxide red, ferric oxide yellow, glycerin, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>72789-090-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE, PLASTIC (72789-090-90) </PackageDescription>
<NDC11Code>72789-0090-90</NDC11Code>
<ProductNDC>72789-090</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Silodosin</ProprietaryName>
<NonProprietaryName>Silodosin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181203</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210687</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>SILODOSIN</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200623</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Silodosin capsule, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see CLINICAL STUDIES (14)]. Silodosin capsule is not indicated for the treatment of hypertension.</IndicationAndUsage>
<Description>Silodosin capsules is the brand name for silodosin, a selective antagonist of alpha-1 adrenoreceptors. The chemical name of silodosin is 1-(3- Hydroxypropyl)-5-[(2R)-2-({2-[2-(2,2,2-trifluoroethoxy) phenoxy]ethyl} amino) propyl]-2,3-dihydro-1H-indole-7-carboxamide and the molecular formula is C 25H 32F 3N 3O 4 with a molecular weight of 495.53. The structural formula of silodosin is:. Silodosin is a white to pale yellowish white powder that melts at approximately 104.72 to 107.5 °C. It is freely soluble in acetic acid, and in absolute alcohol, and insoluble in water. Each Silodosin 8 mg capsule for oral administration contains 8 mg silodosin, and the following inactive ingredients: magnesium stearate, magnesium aluminometasilicate, mannitol, polysorbate 80 and pregelatinized starch. The size #1 hard gelatin capsules contain gelatin and titanium dioxide. The capsules are printed with edible ink containing shellac, propylene glycol, black iron oxide and potassium hydroxide. Each Silodosin 4 mg capsule for oral administration contains 4 mg silodosin, and the following inactive ingredients: magnesium stearate, magnesium aluminometasilicate, mannitol, polysorbate 80 and pregelatinized starch. The size #3 hard gelatin capsules contain gelatin and titanium dioxide. The capsules are printed with edible ink containing shellac, propylene glycol, black iron oxide and potassium hydroxide.</Description>
</NDC>
</NDCList>