{
"NDC": [
{
"NDCCode": "51552-0829-4",
"PackageDescription": "25 g in 1 CONTAINER (51552-0829-4) ",
"NDC11Code": "51552-0829-04",
"ProductNDC": "51552-0829",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Progesterone",
"DosageFormName": "POWDER",
"StartMarketingDate": "20040901",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Fagron Inc",
"SubstanceName": "PROGESTERONE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "01-SEP-04"
},
{
"NDCCode": "37662-0829-4",
"PackageDescription": "10000 PELLET in 1 BOTTLE, GLASS (37662-0829-4) ",
"NDC11Code": "37662-0829-04",
"ProductNDC": "37662-0829",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Euphrasia Officinalis",
"NonProprietaryName": "Euphrasia Officinalis",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220712",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "EUPHRASIA STRICTA",
"StrengthNumber": "200",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2022-07-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220712",
"SamplePackage": "N"
},
{
"NDCCode": "71335-0829-4",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (71335-0829-4) ",
"NDC11Code": "71335-0829-04",
"ProductNDC": "71335-0829",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole Hydrochloride",
"NonProprietaryName": "Ropinirole Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090429",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250129",
"SamplePackage": "N",
"IndicationAndUsage": "Ropinirole Tablets are a non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS). (1.1, 1.2).",
"Description": "Ropinirole tablets contain ropinirole, a non-ergoline dopamine agonist, as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride, USP is a white to yellow solid with a melting range of 243° to 250°C and a solubility of 133 mg/mL in water. Each circular, biconvex, film-coated tablets contains ropinirole hydrochloride USP equivalent to ropinirole free base, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg, respectively. Inactive ingredients consist of: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and one or more of the following: carmine, FD&C Blue No. 2 aluminum lake, FD&C Yellow No. 6 aluminum lake, hypromellose, iron oxides (iron oxide yellow, iron oxide red and iron oxide black), polyethylene glycol, polysorbate 80, titanium dioxide."
},
{
"NDCCode": "51552-0829-3",
"PackageDescription": "10 g in 1 CONTAINER (51552-0829-3) ",
"NDC11Code": "51552-0829-03",
"ProductNDC": "51552-0829",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Progesterone",
"DosageFormName": "POWDER",
"StartMarketingDate": "20040901",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Fagron Inc",
"SubstanceName": "PROGESTERONE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "01-SEP-04"
},
{
"NDCCode": "51552-0829-5",
"PackageDescription": "100 g in 1 CONTAINER (51552-0829-5) ",
"NDC11Code": "51552-0829-05",
"ProductNDC": "51552-0829",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Progesterone",
"DosageFormName": "POWDER",
"StartMarketingDate": "20040901",
"EndMarketingDate": "20240516",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Fagron Inc",
"SubstanceName": "PROGESTERONE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"StartMarketingDatePackage": "01-SEP-04",
"EndMarketingDatePackage": "07-MAR-24"
},
{
"NDCCode": "51552-0829-6",
"PackageDescription": "500 g in 1 CONTAINER (51552-0829-6) ",
"NDC11Code": "51552-0829-06",
"ProductNDC": "51552-0829",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Progesterone",
"DosageFormName": "POWDER",
"StartMarketingDate": "20040901",
"EndMarketingDate": "20240516",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Fagron Inc",
"SubstanceName": "PROGESTERONE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"StartMarketingDatePackage": "01-SEP-04",
"EndMarketingDatePackage": "07-MAR-24"
},
{
"NDCCode": "51552-0829-7",
"PackageDescription": "1000 g in 1 CONTAINER (51552-0829-7) ",
"NDC11Code": "51552-0829-07",
"ProductNDC": "51552-0829",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Progesterone",
"DosageFormName": "POWDER",
"StartMarketingDate": "20040901",
"EndMarketingDate": "20240516",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Fagron Inc",
"SubstanceName": "PROGESTERONE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"StartMarketingDatePackage": "01-SEP-04",
"EndMarketingDatePackage": "16-MAY-24"
},
{
"NDCCode": "0054-0829-25",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0054-0829-25) ",
"NDC11Code": "00054-0829-25",
"ProductNDC": "0054-0829",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Progesterone",
"NonProprietaryName": "Progesterone",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250515",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200456",
"LabelerName": "Hikma Pharmaceuticals USA Inc",
"SubstanceName": "PROGESTERONE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Progesterone [CS], Progesterone [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250515",
"SamplePackage": "N",
"IndicationAndUsage": "Progesterone Capsules are indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets. They are also indicated for use in secondary amenorrhea.",
"Description": "Progesterone Capsules contain micronized progesterone for oral administration. Progesterone has a molecular weight of 314.47 and a molecular formula of C21H30O2. Progesterone (pregn-4-ene-3, 20-dione) is a white or creamy white, odorless, crystalline powder practically insoluble in water, soluble in alcohol, acetone and dioxane and sparingly soluble in vegetable oils, stable in air, melting between 126° and 131°C. The structural formula is. Progesterone is synthesized from a starting material from a plant source and is chemically identical to progesterone of human ovarian origin. Progesterone Capsules are available in multiple strengths to afford dosage flexibility for optimum management. Progesterone Capsules contain 100 mg or 200 mg micronized progesterone, USP. The inactive ingredients for Progesterone Capsules 100 mg include: peanut oil NF, gelatin NF, glycerin USP, lecithin NF, titanium dioxide USP, D&C Yellow No. 10, and FD&C Red No. 40. The inactive ingredients for Progesterone Capsules 200 mg include: peanut oil NF, gelatin NF, glycerin USP, lecithin NF, and titanium dioxide USP."
},
{
"NDCCode": "0178-0829-30",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (0178-0829-30) > 5 BLISTER PACK in 1 BLISTER PACK > 5 TABLET in 1 BLISTER PACK",
"NDC11Code": "00178-0829-30",
"ProductNDC": "0178-0829",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Citranatal 90 Dha",
"NonProprietaryName": "Vitamin C, Calcium, Iron, Vitamin D3, Vitamin E, Thiamin, Riboflavin, Niacinamide, Vitamin B6, Folic Acid, Iodine, Zinc, Copper, Docusate Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100201",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Mission Pharmacal Company",
"SubstanceName": "ASCORBIC ACID; CALCIUM CITRATE; IRON; VITAMIN D; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE; RIBOPRINE; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; POTASSIUM TRIIODIDE; ZINC OXIDE; CUPRIC OXIDE; DOCUSATE SODIUM",
"StrengthNumber": "120; 160; 90; 400; 30; 3; 3.4; 20; 20; 1; 150; 25; 2; 50",
"StrengthUnit": "mg/1; mg/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "CitraNatal® 90 DHA is a multivitamin/mineral prescription drug indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers."
},
{
"NDCCode": "0409-0829-01",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0409-0829-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0409-0829-11) ",
"NDC11Code": "00409-0829-01",
"ProductNDC": "0409-0829",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aztreonam",
"NonProprietaryName": "Aztreonam",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20220124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206517",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "AZTREONAM",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Pharm_Classes": "Monobactam Antibacterial [EPC], Monobactams [CS]",
"Status": "Active",
"LastUpdate": "2024-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220124",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of Aztreonam for Injection, USP and other antibacterial drugs, aztreonam for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Aztreonam for Injection is indicated for the treatment of the following infections caused by susceptible Gram-negative microorganisms. Urinary Tract Infections (complicated and uncomplicated), including pyelonephritis and cystitis (initial and recurrent) caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Enterobacter cloacae, Klebsiella oxytocaEfficacy for this organism in this organ system was studied in fewer than 10 infections., Citrobacter species, and Serratia marcescens. Lower Respiratory Tract Infections, including pneumonia and bronchitis caused by Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Haemophilus influenzae, Proteus mirabilis, Enterobacter species, and Serratia marcescens. Septicemia caused by Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Proteus mirabilis, Serratia marcescens, and Enterobacter species. Skin and Skin-Structure Infections, including those associated with postoperative wounds, ulcers, and burns, caused by Escherichia coli, Proteus mirabilis, Serratia marcescens, Enterobacter species, Pseudomonas aeruginosa, Klebsiella pneumoniae, and Citrobacter species. Intra-abdominal Infections, including peritonitis caused by Escherichia coli, Klebsiella species including K. pneumoniae, Enterobacter species including E. cloacae, Pseudomonas aeruginosa, Citrobacter species including C. freundii, and Serratia species including S. marcescens. Gynecologic Infections, including endometritis and pelvic cellulitis caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter species including E. cloacae, and Proteus mirabilis. Aztreonam for Injection is indicated for adjunctive therapy to surgery in the management of infections caused by susceptible organisms, including abscesses, infections complicating hollow viscus perforations, cutaneous infections, and infections of serous surfaces. Aztreonam for Injection is effective against most of the commonly encountered Gram-negative aerobic pathogens seen in general surgery.",
"Description": "Aztreonam for Injection, USP contains the active ingredient aztreonam, a monobactam. It was originally isolated from Chromobacterium violaceum. It is a synthetic bactericidal antibiotic. The monobactams, having a unique monocyclic beta-lactam nucleus, are structurally different from other beta-lactam antibiotics (eg, penicillins, cephalosporins, cephamycins). The sulfonic acid substituent in the 1-position of the ring activates the beta-lactam moiety; an aminothiazolyl oxime side chain in the 3-position and a methyl group in the 4-position confer the specific antibacterial spectrum and beta-lactamase stability. Aztreonam is designated chemically as (Z)-2-[[[(2-amino-4-thiazolyl)[[(2S,3S)-2-methyl-4-oxo-1-sulfo-3-azetidinyl]carbamoyl]methylene]amino]oxy]-2-methylpropionic acid. Structural formula. Aztreonam for Injection is a sterile, nonpyrogenic, sodium-free, lyophilized, off-white to slightly yellowish solid, containing approximately 780 mg arginine per gram of aztreonam. Following constitution, the product is for intramuscular or intravenous use. Aqueous solutions of the product have a pH in the range of 4.5 to 7.5."
},
{
"NDCCode": "10135-829-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (10135-829-01) ",
"NDC11Code": "10135-0829-01",
"ProductNDC": "10135-829",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acetaminophen",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Marlex Pharmaceuticals Inc",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-02-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260201",
"SamplePackage": "N",
"IndicationAndUsage": "Temporary relieves minor aches and pains due to: 1 The common cold Headache, 2 Backache Minor pain of arthritis, 3 Toothache Muscular aches, 4 Premenstrual and menstrual cramps."
},
{
"NDCCode": "10370-829-05",
"PackageDescription": "500 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (10370-829-05) ",
"NDC11Code": "10370-0829-05",
"ProductNDC": "10370-829",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"ProprietaryNameSuffix": "Extended-release",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20151001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074984",
"LabelerName": "Endo USA, Inc.",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160907",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules, USP is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules, USP is indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "Diltiazem Hydrochloride Extended-Release Capsules, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)-cis-. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem Hydrochloride Extended-Release Capsules, USP is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem) or 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem). Each diltiazem hydrochloride extended-release capsule, contains the following inactive ingredients: ammonio methacrylate copolymer NF, type A, ammonio methacrylate copolymer NF, type B, ammonium hydroxide, gelatin, hydroxypropyl cellulose, propylene glycol, shellac, sodium lauryl sulfate, sucrose, corn starch, talc, titanium dioxide, triethyl citrate and black iron oxide. In addition, the 180 mg capsules contains D&C yellow #10, FD&C blue #1, FD&C green #3, 240 mg capsules contains D&C yellow #10, FD&C green #3 and 300 mg capsules contains black iron oxide, D&C yellow #10, FD&C green #3. For oral administration. This drug product conforms to USP Drug release test #11."
},
{
"NDCCode": "10370-829-09",
"PackageDescription": "90 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (10370-829-09) ",
"NDC11Code": "10370-0829-09",
"ProductNDC": "10370-829",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"ProprietaryNameSuffix": "Extended-release",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20151001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074984",
"LabelerName": "Endo USA, Inc.",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160915",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules, USP is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules, USP is indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "Diltiazem Hydrochloride Extended-Release Capsules, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)-cis-. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem Hydrochloride Extended-Release Capsules, USP is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem) or 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem). Each diltiazem hydrochloride extended-release capsule, contains the following inactive ingredients: ammonio methacrylate copolymer NF, type A, ammonio methacrylate copolymer NF, type B, ammonium hydroxide, gelatin, hydroxypropyl cellulose, propylene glycol, shellac, sodium lauryl sulfate, sucrose, corn starch, talc, titanium dioxide, triethyl citrate and black iron oxide. In addition, the 180 mg capsules contains D&C yellow #10, FD&C blue #1, FD&C green #3, 240 mg capsules contains D&C yellow #10, FD&C green #3 and 300 mg capsules contains black iron oxide, D&C yellow #10, FD&C green #3. For oral administration. This drug product conforms to USP Drug release test #11."
},
{
"NDCCode": "10370-829-11",
"PackageDescription": "30 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (10370-829-11) ",
"NDC11Code": "10370-0829-11",
"ProductNDC": "10370-829",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"ProprietaryNameSuffix": "Extended-release",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20151001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074984",
"LabelerName": "Endo USA, Inc.",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170112",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules, USP is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules, USP is indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "Diltiazem Hydrochloride Extended-Release Capsules, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)-cis-. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem Hydrochloride Extended-Release Capsules, USP is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem) or 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem). Each diltiazem hydrochloride extended-release capsule, contains the following inactive ingredients: ammonio methacrylate copolymer NF, type A, ammonio methacrylate copolymer NF, type B, ammonium hydroxide, gelatin, hydroxypropyl cellulose, propylene glycol, shellac, sodium lauryl sulfate, sucrose, corn starch, talc, titanium dioxide, triethyl citrate and black iron oxide. In addition, the 180 mg capsules contains D&C yellow #10, FD&C blue #1, FD&C green #3, 240 mg capsules contains D&C yellow #10, FD&C green #3 and 300 mg capsules contains black iron oxide, D&C yellow #10, FD&C green #3. For oral administration. This drug product conforms to USP Drug release test #11."
},
{
"NDCCode": "13537-829-02",
"PackageDescription": "1 TUBE in 1 BOX (13537-829-02) > 4 g in 1 TUBE (13537-829-01)",
"NDC11Code": "13537-0829-02",
"ProductNDC": "13537-829",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Esika Hydracolor 2 In 1 Highly Moisturizing And Coloring Spf 25",
"ProprietaryNameSuffix": "(rosa Romantica Femme) - Pink",
"NonProprietaryName": "Octinoxate And Oxybenzone",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20161109",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD",
"SubstanceName": "OCTINOXATE; OXYBENZONE",
"StrengthNumber": ".0664; .0151",
"StrengthUnit": "g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "16571-829-09",
"PackageDescription": "90 TABLET in 1 BOTTLE (16571-829-09) ",
"NDC11Code": "16571-0829-09",
"ProductNDC": "16571-829",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Captopril And Hydrochlorothiazide",
"NonProprietaryName": "Captopril And Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074896",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "CAPTOPRIL; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "50; 15",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2023-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230214",
"SamplePackage": "N",
"IndicationAndUsage": "Captopril and hydrochlorothiazide tablets are indicated for the treatment of hypertension. The blood pressure lowering effects of captopril and thiazides are approximately additive. This fixed combination drug may be used as initial therapy or substituted for previously titrated doses of the individual components. When captopril and hydrochlorothiazide are given together it may not be necessary to administer captopril in divided doses to attain blood pressure control at trough (before the next dose). Also, with such a combination, a daily dose of 15 mg of hydrochlorothiazide may be adequate. Treatment may, therefore, be initiated with captopril and hydrochlorothiazide tablets 25 mg/15 mg once daily. Subsequent titration should be with additional doses of the components (captopril, hydrochlorothiazide) as single agents or as captopril and hydrochlorothiazide tablets 50 mg/15 mg, 25 mg/25 mg, or 50 mg/25 mg (see DOSAGE AND ADMINISTRATION). In using captopril and hydrochlorothiazide, consideration should be given to the risk of neutropenia/agranulocytosis (see WARNINGS). Captopril and hydrochlorothiazide may be used for patients with normal renal function, in whom the risk is relatively low. In patients with impaired renal function, particularly those with collagen vascular disease, captopril and hydrochlorothiazide should be reserved for hypertensives who have either developed unacceptable side effects on other drugs, or have failed to respond satisfactorily to other drug combinations. ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS: Captopril: Head and Neck Angioedema and Intestinal Angioedema).",
"Description": "Captopril and hydrochlorothiazide tablets, USP for oral administration combines two antihypertensive agents: captopril and hydrochlorothiazide. Captopril, the first of a new class of antihypertensive agents, is a specific competitive inhibitor of angiotensin I-converting enzyme (ACE), the enzyme responsible for the conversion of angiotensin I to angiotensin II. Hydrochlorothiazide is a benzothiadiazide (thiazide) diuretic-antihypertensive. Captopril, USP is a white to off-white crystalline powder with characteristic sulfide-like odor; it is freely soluble in water, ethanol, methanol, chloroform, isopropyl alcohol and methylene chloride and soluble in ethyl acetate. It dissolves in dilute solution of alkali hydroxide. Hydrochlorothiazide, USP is a white or almost white, almost odorless crystalline powder. Very slightly soluble in water, sparingly soluble in Ethanol and Methanol, soluble in Acetone. Freely soluble in N,N-Dimethylformamide, in n-Butylamine and in diluted solutions of alkali hydroxides. Practically insoluble in Ether, in Chloroform and in diluted mineral acids. Captopril is designated chemically as 1-[(2S)-3-Mercapto-2-methylpropionyl]-L-proline; Hydrochlorothiazide is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Their structural formulas are. Captopril and hydrochlorothiazide tablets are available for oral administration in four combinations of captopril with hydrochlorothiazide: 25 mg with 15 mg, 25 mg with 25 mg, 50 mg with 15 mg, and 50 mg with 25 mg. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The 25 mg/25 mg and 50 mg/25 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake."
},
{
"NDCCode": "16714-829-01",
"PackageDescription": "100 CAPSULE, COATED PELLETS in 1 BOTTLE (16714-829-01) ",
"NDC11Code": "16714-0829-01",
"ProductNDC": "16714-829",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Budesonide",
"NonProprietaryName": "Budesonide",
"DosageFormName": "CAPSULE, COATED PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20180625",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206134",
"LabelerName": "Northstar Rx LLC.",
"SubstanceName": "BUDESONIDE",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180625",
"SamplePackage": "N",
"IndicationAndUsage": "Budesonide delayed-release capsules are corticosteroid indicated for: 1 Treatment of mild to moderate active Crohn's disease involving the ileum and/or the ascending colon, in patients 8 years and older. (1.1), 2 Maintenance of clinical remission of mild to moderate Crohn's disease involving the ileum and/or the ascending colon for up to 3 months in adults. (1.2).",
"Description": "Budesonide USP, the active ingredient of budesonide delayed-release capsules, is a synthetic corticosteroid. Budesonide is designated chemically as (RS)-11β, 16α, 17,21- tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The molecular formula of budesonide is C25H34O6 and its molecular weight is 430.5. Its structural formula is:. Budesonide, USP is a white to off-white, odorless, crystalline powder that is practically insoluble in water and heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 5 is 1.6 x 103ionic strength 0.01. Each capsule for oral administration contains 3 mg of micronized budesonide with the following inactive ingredients: acetyltributyl citrate, ethylcellulose aqueous dispersion, gelatin, iron oxide red, iron oxide yellow, methacrylic acid copolymer dispersion, polysorbate 80, simethicone emulsion, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide and triethyl citrate. The capsule shell is printed with black pharmaceutical ink which contains following ingredients: iron oxide black, potassium hydroxide, propylene glycol and shellac."
},
{
"NDCCode": "21695-829-40",
"PackageDescription": "40 g in 1 TUBE (21695-829-40)",
"NDC11Code": "21695-0829-40",
"ProductNDC": "21695-829",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluorouracil",
"NonProprietaryName": "Fluorouracil",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080411",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077524",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "FLUOROURACIL",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Fluorouracil Cream is recommended for the topical treatment of multiple actinic or solar keratoses. In the 5% strength it is also useful in the treatment of superficial basal cell carcinomas when conventional methods are impractical, such as with multiple lesions or difficult treatment sites. Safety and efficacy in other indications have not been established. The diagnosis should be established prior to treatment, since this method has not been proven effective in other types of basal cell carcinomas. With isolated, easily accessible basal cell carcinomas, surgery is preferred since success with such lesions is almost 100%. The success rate with Fluorouracil Cream is approximately 93%, based on 113 lesions in 54 patients. Eighty-eight lesions treated with the cream produced 7 failures.",
"Description": "Fluorouracil Cream, USP 5% is a topical preparation containing the fluorinated pyrimidine 5-fluorouracil, an antineoplastic antimetabolite. Fluorouracil Cream contains 5% fluorouracil in a vanishing cream base consisting of purified water, white petrolatum, cetyl alcohol, stearyl alcohol, propylene glycol, polysorbate 60 and parabens (methyl and propyl). Chemically, fluorouracil is 5-fluoro-2,4(1H,3H)-pyrimidinedione. It is a white to practically white, crystalline powder which is sparingly soluble in water and slightly soluble in alcohol. One gram of fluorouracil is soluble in 100 mL of propylene glycol. The molecular weight of 5-fluorouracil is 130.08 and the structural formula is."
},
{
"NDCCode": "25021-829-02",
"PackageDescription": "1 VIAL in 1 CARTON (25021-829-02) / 1.5 mL in 1 VIAL",
"NDC11Code": "25021-0829-02",
"ProductNDC": "25021-829",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fomepizole",
"NonProprietaryName": "Fomepizole",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20231115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216791",
"LabelerName": "Sagent Pharmaceuticals",
"SubstanceName": "FOMEPIZOLE",
"StrengthNumber": "1.5",
"StrengthUnit": "g/1.5mL",
"Pharm_Classes": "Antidote [EPC]",
"Status": "Active",
"LastUpdate": "2023-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231115",
"SamplePackage": "N",
"IndicationAndUsage": "Fomepizole injection is indicated as an antidote for ethylene glycol (such as antifreeze) or methanol poisoning, or for use in suspected ethylene glycol or methanol ingestion, either alone or in combination with hemodialysis (see DOSAGE AND ADMINISTRATION).",
"Description": "Fomepizole Injection is intended for intravenous use. Fomepizole Injection is a competitive inhibitor of alcohol dehydrogenase. The chemical name of fomepizole is 4-methylpyrazole. It has the molecular formula C4H6N2 and a molecular weight of 82.1. The structural formula is:. It is a clear to yellow liquid at room temperature. Its melting point is 25°C (77°F) and it may present as solid at room temperature. Fomepizole is soluble in water and very soluble in ethanol, diethyl ether, and chloroform. Each vial contains 1.5 mL (1 gram per mL) of fomepizole."
},
{
"NDCCode": "31722-829-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (31722-829-01) ",
"NDC11Code": "31722-0829-01",
"ProductNDC": "31722-829",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aripiprazole",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150428",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205064",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2024-02-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150428",
"SamplePackage": "N",
"IndicationAndUsage": "Aripiprazole oral tablets are indicated for the treatment of: 1 Schizophrenia , 2 Treatment of Tourette’s Disorder .",
"Description": "Aripiprazole is a psychotropic drug that is available as aripiprazole tablets. Aripiprazole tablets, USP are chemically designated as 7-[4-[4-(2,3-Dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydro-2(1H)-quinolinone. The molecular formula is C 23H 27C l2N 3O 2, and molecular weight is 448.39. The chemical structure is as follows:. Aripiprazole tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include corn starch, FD&C Blue #2/Indigo Carmine Al, ferric oxide red, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "31722-829-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (31722-829-05) ",
"NDC11Code": "31722-0829-05",
"ProductNDC": "31722-829",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aripiprazole",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150428",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205064",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2024-02-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240202",
"SamplePackage": "N",
"IndicationAndUsage": "Aripiprazole oral tablets are indicated for the treatment of: 1 Schizophrenia , 2 Treatment of Tourette’s Disorder .",
"Description": "Aripiprazole is a psychotropic drug that is available as aripiprazole tablets. Aripiprazole tablets, USP are chemically designated as 7-[4-[4-(2,3-Dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydro-2(1H)-quinolinone. The molecular formula is C 23H 27C l2N 3O 2, and molecular weight is 448.39. The chemical structure is as follows:. Aripiprazole tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include corn starch, FD&C Blue #2/Indigo Carmine Al, ferric oxide red, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "31722-829-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (31722-829-30) ",
"NDC11Code": "31722-0829-30",
"ProductNDC": "31722-829",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aripiprazole",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150428",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205064",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2024-02-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150428",
"SamplePackage": "N",
"IndicationAndUsage": "Aripiprazole oral tablets are indicated for the treatment of: 1 Schizophrenia , 2 Treatment of Tourette’s Disorder .",
"Description": "Aripiprazole is a psychotropic drug that is available as aripiprazole tablets. Aripiprazole tablets, USP are chemically designated as 7-[4-[4-(2,3-Dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydro-2(1H)-quinolinone. The molecular formula is C 23H 27C l2N 3O 2, and molecular weight is 448.39. The chemical structure is as follows:. Aripiprazole tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include corn starch, FD&C Blue #2/Indigo Carmine Al, ferric oxide red, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "31722-829-31",
"PackageDescription": "10 TABLET in 1 BLISTER PACK (31722-829-31) ",
"NDC11Code": "31722-0829-31",
"ProductNDC": "31722-829",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aripiprazole",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150428",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205064",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2024-02-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150428",
"SamplePackage": "N",
"IndicationAndUsage": "Aripiprazole oral tablets are indicated for the treatment of: 1 Schizophrenia , 2 Treatment of Tourette’s Disorder .",
"Description": "Aripiprazole is a psychotropic drug that is available as aripiprazole tablets. Aripiprazole tablets, USP are chemically designated as 7-[4-[4-(2,3-Dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydro-2(1H)-quinolinone. The molecular formula is C 23H 27C l2N 3O 2, and molecular weight is 448.39. The chemical structure is as follows:. Aripiprazole tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include corn starch, FD&C Blue #2/Indigo Carmine Al, ferric oxide red, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "31722-829-32",
"PackageDescription": "250 TABLET in 1 CARTON (31722-829-32) ",
"NDC11Code": "31722-0829-32",
"ProductNDC": "31722-829",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aripiprazole",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150428",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205064",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2024-02-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150428",
"SamplePackage": "N",
"IndicationAndUsage": "Aripiprazole oral tablets are indicated for the treatment of: 1 Schizophrenia , 2 Treatment of Tourette’s Disorder .",
"Description": "Aripiprazole is a psychotropic drug that is available as aripiprazole tablets. Aripiprazole tablets, USP are chemically designated as 7-[4-[4-(2,3-Dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydro-2(1H)-quinolinone. The molecular formula is C 23H 27C l2N 3O 2, and molecular weight is 448.39. The chemical structure is as follows:. Aripiprazole tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include corn starch, FD&C Blue #2/Indigo Carmine Al, ferric oxide red, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "33261-829-30",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (33261-829-30)",
"NDC11Code": "33261-0829-30",
"ProductNDC": "33261-829",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19991228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075116",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "240",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Diltiazem Hydrochloride Extended-release Capsules (Once-a-Day Dosage) are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem Hydrochloride Extended-release Capsules (Once-a-Day Dosage) are indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one,3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The structural formula is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol and chloroform. It has a molecular weight of 450.98. Diltiazem Hydrochloride Extended-release Capsule (Once-a-Day Dosage), is formulated as a once-a-day extended-release capsule containing 120 mg, 180 mg, 240 mg, or 300 mg diltiazem hydrochloride. Also contains: D&C Yellow #10, FD&C Green #3, gelatin, hypromellose, magnesium stearate, microcrystalline cellulose, polyacrylate dispersion 30%, polysorbate, povidone, simethicone, sucrose stearate, talc, and titanium dioxide. Diltiazem Hydrochloride Extended-release Capsule meets USP Dissolution Test 12. For oral administration."
},
{
"NDCCode": "42291-829-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (42291-829-50) ",
"NDC11Code": "42291-0829-50",
"ProductNDC": "42291-829",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trazodone Hydrochloride",
"NonProprietaryName": "Trazodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200417",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071525",
"LabelerName": "AvKARE",
"SubstanceName": "TRAZODONE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200417",
"SamplePackage": "N",
"IndicationAndUsage": "Trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults.",
"Description": "Trazodone Hydrochloride Tablets, USP for oral administration contain trazodone hydrochloride, a selective serotonin reuptake inhibitor and 5HT2 receptor antagonist. Trazodone hydrochloride, USP is a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-1,2,4-triazolo[4, 3-a]pyridin-3(2 H)-one hydrochloride. It is a white, odorless crystalline powder which is freely soluble in water. The structural formula is represented as follows:. C 19H 22CIN 5O HCl M.W. 408.33. Each tablet, for oral administration, contains 50 mg, 100 mg or 150 mg of trazodone hydrochloride, USP. In addition, each tablet contains colloidal silicon dioxide, lactose anhydrous, magnesium stearate, microcrystalline cellulose and sodium starch glycolate."
},
{
"NDCCode": "42291-829-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (42291-829-90) ",
"NDC11Code": "42291-0829-90",
"ProductNDC": "42291-829",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trazodone Hydrochloride",
"NonProprietaryName": "Trazodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200417",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071525",
"LabelerName": "AvKARE",
"SubstanceName": "TRAZODONE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200417",
"SamplePackage": "N",
"IndicationAndUsage": "Trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults.",
"Description": "Trazodone Hydrochloride Tablets, USP for oral administration contain trazodone hydrochloride, a selective serotonin reuptake inhibitor and 5HT2 receptor antagonist. Trazodone hydrochloride, USP is a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-1,2,4-triazolo[4, 3-a]pyridin-3(2 H)-one hydrochloride. It is a white, odorless crystalline powder which is freely soluble in water. The structural formula is represented as follows:. C 19H 22CIN 5O HCl M.W. 408.33. Each tablet, for oral administration, contains 50 mg, 100 mg or 150 mg of trazodone hydrochloride, USP. In addition, each tablet contains colloidal silicon dioxide, lactose anhydrous, magnesium stearate, microcrystalline cellulose and sodium starch glycolate."
},
{
"NDCCode": "43353-829-60",
"PackageDescription": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43353-829-60) ",
"NDC11Code": "43353-0829-60",
"ProductNDC": "43353-829",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omeprazole",
"NonProprietaryName": "Omeprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20090123",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075410",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2020-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130325",
"SamplePackage": "N",
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"Description": "The active ingredient in Omeprazole Delayed-Release Capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole Delayed-Release Capsules meet USP Dissolution Test 2. Omeprazole Delayed-Release Capsules is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg, or 40 mg of omeprazole in the form of enteric-coated microtablets with the following inactive ingredients: crospovidone, glyceryl behenate, hypromellose, lactose monohydrate, methacrylic acid copolymer dispersion, silicon dioxide, talc, titanium dioxide and triethyl citrate. In addition, the capsule shells contain gelatin and may contain sodium lauryl sulfate. In addition, the 20 mg and 40 mg capsule shells also contain yellow iron oxide. The imprinting ink also contains ammonium hydroxide, butyl alcohol, black iron oxide, isopropyl alcohol, propylene glycol and shellac glaze. The ink may also contain dehydrated alcohol."
},
{
"NDCCode": "43353-829-80",
"PackageDescription": "180 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43353-829-80) ",
"NDC11Code": "43353-0829-80",
"ProductNDC": "43353-829",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omeprazole",
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"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
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"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"Description": "The active ingredient in Omeprazole Delayed-Release Capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole Delayed-Release Capsules meet USP Dissolution Test 2. Omeprazole Delayed-Release Capsules is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg, or 40 mg of omeprazole in the form of enteric-coated microtablets with the following inactive ingredients: crospovidone, glyceryl behenate, hypromellose, lactose monohydrate, methacrylic acid copolymer dispersion, silicon dioxide, talc, titanium dioxide and triethyl citrate. In addition, the capsule shells contain gelatin and may contain sodium lauryl sulfate. In addition, the 20 mg and 40 mg capsule shells also contain yellow iron oxide. The imprinting ink also contains ammonium hydroxide, butyl alcohol, black iron oxide, isopropyl alcohol, propylene glycol and shellac glaze. The ink may also contain dehydrated alcohol."
},
{
"NDCCode": "43742-0829-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (43742-0829-1) ",
"NDC11Code": "43742-0829-01",
"ProductNDC": "43742-0829",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mucous Membrane Core Formula",
"NonProprietaryName": "Ceanothus Americanus, Veratrum Album, Anacardium Orientale, Argentum Nitricum, Condurango, Hydrastis Canadensis, Momordica Balsamina, Oxalis Acetosella, Pulsatilla (vulgaris), Bile Duct (suis), Colon (suis), Duodenum (suis), Esophagus (suis), Eye (suis), Gallbladder (suis), Ileum (suis), Intestine (suis), Ipecacuanha, Jejunum (suis), Kali Bichromicum, Lung (suis), Mucosa Nasalis Suis, Natrum Oxalaceticum, Oral Mucosa (suis), Pancreas Suis, Phosphorus, Rectal Mucosa (suis), Stomach (suis), Sulphur",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20160817",
"EndMarketingDate": "20220307",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Deseret Biologicals, Inc.",
"SubstanceName": "ATROPA BELLADONNA; CEANOTHUS AMERICANUS LEAF; GOLDENSEAL; IPECAC; LACHESIS MUTA VENOM; MANDRAGORA OFFICINARUM ROOT; MARSDENIA CONDURANGO BARK; MOMORDICA BALSAMINA IMMATURE FRUIT; OXALIS ACETOSELLA LEAF; PHOSPHORUS; PORK INTESTINE; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SEMECARPUS ANACARDIUM JUICE; SHIGELLA DYSENTERIAE; SILVER NITRATE; SODIUM DIETHYL OXALACETATE; SULFUR; SUS SCROFA BILE DUCT; SUS SCROFA COLON; SUS SCROFA DUODENUM; SUS SCROFA ESOPHAGUS; SUS SCROFA EYE; SUS SCROFA GALLBLADDER; SUS SCROFA ILEUM; SUS SCROFA JEJUNUM; SUS SCROFA LARGE INTESTINE; SUS SCROFA LUNG; SUS SCROFA NASAL MUCOSA; SUS SCROFA ORAL MUCOSA; SUS SCROFA PANCREAS; SUS SCROFA RECTAL MUCOSA; SUS SCROFA STOMACH; SUS SCROFA URINARY BLADDER; VERATRUM ALBUM ROOT; WOOD CREOSOTE; YEAST MANNAN",
"StrengthNumber": "10; 4; 6; 8; 10; 10; 6; 6; 6; 8; 8; 8; 6; 6; 30; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 6; 4; 10; 8",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2022-03-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160817",
"EndMarketingDatePackage": "20220307",
"SamplePackage": "N"
}
]
}
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<NDCList>
<NDC>
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<PackageDescription>25 g in 1 CONTAINER (51552-0829-4) </PackageDescription>
<NDC11Code>51552-0829-04</NDC11Code>
<ProductNDC>51552-0829</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Progesterone</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20040901</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Fagron Inc</LabelerName>
<SubstanceName>PROGESTERONE</SubstanceName>
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<StrengthUnit>g/g</StrengthUnit>
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<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
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</NDC>
<NDC>
<NDCCode>37662-0829-4</NDCCode>
<PackageDescription>10000 PELLET in 1 BOTTLE, GLASS (37662-0829-4) </PackageDescription>
<NDC11Code>37662-0829-04</NDC11Code>
<ProductNDC>37662-0829</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Euphrasia Officinalis</ProprietaryName>
<NonProprietaryName>Euphrasia Officinalis</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220712</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>EUPHRASIA STRICTA</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-07-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220712</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71335-0829-4</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (71335-0829-4) </PackageDescription>
<NDC11Code>71335-0829-04</NDC11Code>
<ProductNDC>71335-0829</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropinirole Hydrochloride</ProprietaryName>
<NonProprietaryName>Ropinirole Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090429</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ropinirole Tablets are a non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS). (1.1, 1.2).</IndicationAndUsage>
<Description>Ropinirole tablets contain ropinirole, a non-ergoline dopamine agonist, as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride, USP is a white to yellow solid with a melting range of 243° to 250°C and a solubility of 133 mg/mL in water. Each circular, biconvex, film-coated tablets contains ropinirole hydrochloride USP equivalent to ropinirole free base, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg, respectively. Inactive ingredients consist of: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and one or more of the following: carmine, FD&C Blue No. 2 aluminum lake, FD&C Yellow No. 6 aluminum lake, hypromellose, iron oxides (iron oxide yellow, iron oxide red and iron oxide black), polyethylene glycol, polysorbate 80, titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>51552-0829-3</NDCCode>
<PackageDescription>10 g in 1 CONTAINER (51552-0829-3) </PackageDescription>
<NDC11Code>51552-0829-03</NDC11Code>
<ProductNDC>51552-0829</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Progesterone</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20040901</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Fagron Inc</LabelerName>
<SubstanceName>PROGESTERONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-SEP-04</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>51552-0829-5</NDCCode>
<PackageDescription>100 g in 1 CONTAINER (51552-0829-5) </PackageDescription>
<NDC11Code>51552-0829-05</NDC11Code>
<ProductNDC>51552-0829</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Progesterone</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20040901</StartMarketingDate>
<EndMarketingDate>20240516</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Fagron Inc</LabelerName>
<SubstanceName>PROGESTERONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<StartMarketingDatePackage>01-SEP-04</StartMarketingDatePackage>
<EndMarketingDatePackage>07-MAR-24</EndMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>51552-0829-6</NDCCode>
<PackageDescription>500 g in 1 CONTAINER (51552-0829-6) </PackageDescription>
<NDC11Code>51552-0829-06</NDC11Code>
<ProductNDC>51552-0829</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Progesterone</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20040901</StartMarketingDate>
<EndMarketingDate>20240516</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Fagron Inc</LabelerName>
<SubstanceName>PROGESTERONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<StartMarketingDatePackage>01-SEP-04</StartMarketingDatePackage>
<EndMarketingDatePackage>07-MAR-24</EndMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>51552-0829-7</NDCCode>
<PackageDescription>1000 g in 1 CONTAINER (51552-0829-7) </PackageDescription>
<NDC11Code>51552-0829-07</NDC11Code>
<ProductNDC>51552-0829</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Progesterone</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20040901</StartMarketingDate>
<EndMarketingDate>20240516</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Fagron Inc</LabelerName>
<SubstanceName>PROGESTERONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<StartMarketingDatePackage>01-SEP-04</StartMarketingDatePackage>
<EndMarketingDatePackage>16-MAY-24</EndMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>0054-0829-25</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0054-0829-25) </PackageDescription>
<NDC11Code>00054-0829-25</NDC11Code>
<ProductNDC>0054-0829</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Progesterone</ProprietaryName>
<NonProprietaryName>Progesterone</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250515</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200456</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc</LabelerName>
<SubstanceName>PROGESTERONE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Progesterone [CS], Progesterone [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Progesterone Capsules are indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets. They are also indicated for use in secondary amenorrhea.</IndicationAndUsage>
<Description>Progesterone Capsules contain micronized progesterone for oral administration. Progesterone has a molecular weight of 314.47 and a molecular formula of C21H30O2. Progesterone (pregn-4-ene-3, 20-dione) is a white or creamy white, odorless, crystalline powder practically insoluble in water, soluble in alcohol, acetone and dioxane and sparingly soluble in vegetable oils, stable in air, melting between 126° and 131°C. The structural formula is. Progesterone is synthesized from a starting material from a plant source and is chemically identical to progesterone of human ovarian origin. Progesterone Capsules are available in multiple strengths to afford dosage flexibility for optimum management. Progesterone Capsules contain 100 mg or 200 mg micronized progesterone, USP. The inactive ingredients for Progesterone Capsules 100 mg include: peanut oil NF, gelatin NF, glycerin USP, lecithin NF, titanium dioxide USP, D&C Yellow No. 10, and FD&C Red No. 40. The inactive ingredients for Progesterone Capsules 200 mg include: peanut oil NF, gelatin NF, glycerin USP, lecithin NF, and titanium dioxide USP.</Description>
</NDC>
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<NDCCode>0178-0829-30</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 CARTON (0178-0829-30) > 5 BLISTER PACK in 1 BLISTER PACK > 5 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00178-0829-30</NDC11Code>
<ProductNDC>0178-0829</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Citranatal 90 Dha</ProprietaryName>
<NonProprietaryName>Vitamin C, Calcium, Iron, Vitamin D3, Vitamin E, Thiamin, Riboflavin, Niacinamide, Vitamin B6, Folic Acid, Iodine, Zinc, Copper, Docusate Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100201</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Mission Pharmacal Company</LabelerName>
<SubstanceName>ASCORBIC ACID; CALCIUM CITRATE; IRON; VITAMIN D; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE; RIBOPRINE; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; POTASSIUM TRIIODIDE; ZINC OXIDE; CUPRIC OXIDE; DOCUSATE SODIUM</SubstanceName>
<StrengthNumber>120; 160; 90; 400; 30; 3; 3.4; 20; 20; 1; 150; 25; 2; 50</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>CitraNatal® 90 DHA is a multivitamin/mineral prescription drug indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0409-0829-01</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (0409-0829-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0409-0829-11) </PackageDescription>
<NDC11Code>00409-0829-01</NDC11Code>
<ProductNDC>0409-0829</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aztreonam</ProprietaryName>
<NonProprietaryName>Aztreonam</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20220124</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206517</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>AZTREONAM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Monobactam Antibacterial [EPC], Monobactams [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220124</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of Aztreonam for Injection, USP and other antibacterial drugs, aztreonam for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Aztreonam for Injection is indicated for the treatment of the following infections caused by susceptible Gram-negative microorganisms. Urinary Tract Infections (complicated and uncomplicated), including pyelonephritis and cystitis (initial and recurrent) caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Enterobacter cloacae, Klebsiella oxytocaEfficacy for this organism in this organ system was studied in fewer than 10 infections., Citrobacter species, and Serratia marcescens. Lower Respiratory Tract Infections, including pneumonia and bronchitis caused by Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Haemophilus influenzae, Proteus mirabilis, Enterobacter species, and Serratia marcescens. Septicemia caused by Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Proteus mirabilis, Serratia marcescens, and Enterobacter species. Skin and Skin-Structure Infections, including those associated with postoperative wounds, ulcers, and burns, caused by Escherichia coli, Proteus mirabilis, Serratia marcescens, Enterobacter species, Pseudomonas aeruginosa, Klebsiella pneumoniae, and Citrobacter species. Intra-abdominal Infections, including peritonitis caused by Escherichia coli, Klebsiella species including K. pneumoniae, Enterobacter species including E. cloacae, Pseudomonas aeruginosa, Citrobacter species including C. freundii, and Serratia species including S. marcescens. Gynecologic Infections, including endometritis and pelvic cellulitis caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter species including E. cloacae, and Proteus mirabilis. Aztreonam for Injection is indicated for adjunctive therapy to surgery in the management of infections caused by susceptible organisms, including abscesses, infections complicating hollow viscus perforations, cutaneous infections, and infections of serous surfaces. Aztreonam for Injection is effective against most of the commonly encountered Gram-negative aerobic pathogens seen in general surgery.</IndicationAndUsage>
<Description>Aztreonam for Injection, USP contains the active ingredient aztreonam, a monobactam. It was originally isolated from Chromobacterium violaceum. It is a synthetic bactericidal antibiotic. The monobactams, having a unique monocyclic beta-lactam nucleus, are structurally different from other beta-lactam antibiotics (eg, penicillins, cephalosporins, cephamycins). The sulfonic acid substituent in the 1-position of the ring activates the beta-lactam moiety; an aminothiazolyl oxime side chain in the 3-position and a methyl group in the 4-position confer the specific antibacterial spectrum and beta-lactamase stability. Aztreonam is designated chemically as (Z)-2-[[[(2-amino-4-thiazolyl)[[(2S,3S)-2-methyl-4-oxo-1-sulfo-3-azetidinyl]carbamoyl]methylene]amino]oxy]-2-methylpropionic acid. Structural formula. Aztreonam for Injection is a sterile, nonpyrogenic, sodium-free, lyophilized, off-white to slightly yellowish solid, containing approximately 780 mg arginine per gram of aztreonam. Following constitution, the product is for intramuscular or intravenous use. Aqueous solutions of the product have a pH in the range of 4.5 to 7.5.</Description>
</NDC>
<NDC>
<NDCCode>10135-829-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (10135-829-01) </PackageDescription>
<NDC11Code>10135-0829-01</NDC11Code>
<ProductNDC>10135-829</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals Inc</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-02-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporary relieves minor aches and pains due to: 1 The common cold Headache, 2 Backache Minor pain of arthritis, 3 Toothache Muscular aches, 4 Premenstrual and menstrual cramps.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10370-829-05</NDCCode>
<PackageDescription>500 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (10370-829-05) </PackageDescription>
<NDC11Code>10370-0829-05</NDC11Code>
<ProductNDC>10370-829</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Extended-release</ProprietaryNameSuffix>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074984</ApplicationNumber>
<LabelerName>Endo USA, Inc.</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160907</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem hydrochloride extended-release capsules, USP is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules, USP is indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
<Description>Diltiazem Hydrochloride Extended-Release Capsules, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)-cis-. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem Hydrochloride Extended-Release Capsules, USP is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem) or 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem). Each diltiazem hydrochloride extended-release capsule, contains the following inactive ingredients: ammonio methacrylate copolymer NF, type A, ammonio methacrylate copolymer NF, type B, ammonium hydroxide, gelatin, hydroxypropyl cellulose, propylene glycol, shellac, sodium lauryl sulfate, sucrose, corn starch, talc, titanium dioxide, triethyl citrate and black iron oxide. In addition, the 180 mg capsules contains D&C yellow #10, FD&C blue #1, FD&C green #3, 240 mg capsules contains D&C yellow #10, FD&C green #3 and 300 mg capsules contains black iron oxide, D&C yellow #10, FD&C green #3. For oral administration. This drug product conforms to USP Drug release test #11.</Description>
</NDC>
<NDC>
<NDCCode>10370-829-09</NDCCode>
<PackageDescription>90 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (10370-829-09) </PackageDescription>
<NDC11Code>10370-0829-09</NDC11Code>
<ProductNDC>10370-829</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Extended-release</ProprietaryNameSuffix>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074984</ApplicationNumber>
<LabelerName>Endo USA, Inc.</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem hydrochloride extended-release capsules, USP is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules, USP is indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
<Description>Diltiazem Hydrochloride Extended-Release Capsules, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)-cis-. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem Hydrochloride Extended-Release Capsules, USP is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem) or 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem). Each diltiazem hydrochloride extended-release capsule, contains the following inactive ingredients: ammonio methacrylate copolymer NF, type A, ammonio methacrylate copolymer NF, type B, ammonium hydroxide, gelatin, hydroxypropyl cellulose, propylene glycol, shellac, sodium lauryl sulfate, sucrose, corn starch, talc, titanium dioxide, triethyl citrate and black iron oxide. In addition, the 180 mg capsules contains D&C yellow #10, FD&C blue #1, FD&C green #3, 240 mg capsules contains D&C yellow #10, FD&C green #3 and 300 mg capsules contains black iron oxide, D&C yellow #10, FD&C green #3. For oral administration. This drug product conforms to USP Drug release test #11.</Description>
</NDC>
<NDC>
<NDCCode>10370-829-11</NDCCode>
<PackageDescription>30 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (10370-829-11) </PackageDescription>
<NDC11Code>10370-0829-11</NDC11Code>
<ProductNDC>10370-829</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Extended-release</ProprietaryNameSuffix>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074984</ApplicationNumber>
<LabelerName>Endo USA, Inc.</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170112</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem hydrochloride extended-release capsules, USP is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules, USP is indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
<Description>Diltiazem Hydrochloride Extended-Release Capsules, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)-cis-. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem Hydrochloride Extended-Release Capsules, USP is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem) or 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem). Each diltiazem hydrochloride extended-release capsule, contains the following inactive ingredients: ammonio methacrylate copolymer NF, type A, ammonio methacrylate copolymer NF, type B, ammonium hydroxide, gelatin, hydroxypropyl cellulose, propylene glycol, shellac, sodium lauryl sulfate, sucrose, corn starch, talc, titanium dioxide, triethyl citrate and black iron oxide. In addition, the 180 mg capsules contains D&C yellow #10, FD&C blue #1, FD&C green #3, 240 mg capsules contains D&C yellow #10, FD&C green #3 and 300 mg capsules contains black iron oxide, D&C yellow #10, FD&C green #3. For oral administration. This drug product conforms to USP Drug release test #11.</Description>
</NDC>
<NDC>
<NDCCode>13537-829-02</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (13537-829-02) > 4 g in 1 TUBE (13537-829-01)</PackageDescription>
<NDC11Code>13537-0829-02</NDC11Code>
<ProductNDC>13537-829</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Esika Hydracolor 2 In 1 Highly Moisturizing And Coloring Spf 25</ProprietaryName>
<ProprietaryNameSuffix>(rosa Romantica Femme) - Pink</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName>
<DosageFormName>LIPSTICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20161109</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation LTD</LabelerName>
<SubstanceName>OCTINOXATE; OXYBENZONE</SubstanceName>
<StrengthNumber>.0664; .0151</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>16571-829-09</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (16571-829-09) </PackageDescription>
<NDC11Code>16571-0829-09</NDC11Code>
<ProductNDC>16571-829</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Captopril And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Captopril And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074896</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>CAPTOPRIL; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>50; 15</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Captopril and hydrochlorothiazide tablets are indicated for the treatment of hypertension. The blood pressure lowering effects of captopril and thiazides are approximately additive. This fixed combination drug may be used as initial therapy or substituted for previously titrated doses of the individual components. When captopril and hydrochlorothiazide are given together it may not be necessary to administer captopril in divided doses to attain blood pressure control at trough (before the next dose). Also, with such a combination, a daily dose of 15 mg of hydrochlorothiazide may be adequate. Treatment may, therefore, be initiated with captopril and hydrochlorothiazide tablets 25 mg/15 mg once daily. Subsequent titration should be with additional doses of the components (captopril, hydrochlorothiazide) as single agents or as captopril and hydrochlorothiazide tablets 50 mg/15 mg, 25 mg/25 mg, or 50 mg/25 mg (see DOSAGE AND ADMINISTRATION). In using captopril and hydrochlorothiazide, consideration should be given to the risk of neutropenia/agranulocytosis (see WARNINGS). Captopril and hydrochlorothiazide may be used for patients with normal renal function, in whom the risk is relatively low. In patients with impaired renal function, particularly those with collagen vascular disease, captopril and hydrochlorothiazide should be reserved for hypertensives who have either developed unacceptable side effects on other drugs, or have failed to respond satisfactorily to other drug combinations. ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS: Captopril: Head and Neck Angioedema and Intestinal Angioedema).</IndicationAndUsage>
<Description>Captopril and hydrochlorothiazide tablets, USP for oral administration combines two antihypertensive agents: captopril and hydrochlorothiazide. Captopril, the first of a new class of antihypertensive agents, is a specific competitive inhibitor of angiotensin I-converting enzyme (ACE), the enzyme responsible for the conversion of angiotensin I to angiotensin II. Hydrochlorothiazide is a benzothiadiazide (thiazide) diuretic-antihypertensive. Captopril, USP is a white to off-white crystalline powder with characteristic sulfide-like odor; it is freely soluble in water, ethanol, methanol, chloroform, isopropyl alcohol and methylene chloride and soluble in ethyl acetate. It dissolves in dilute solution of alkali hydroxide. Hydrochlorothiazide, USP is a white or almost white, almost odorless crystalline powder. Very slightly soluble in water, sparingly soluble in Ethanol and Methanol, soluble in Acetone. Freely soluble in N,N-Dimethylformamide, in n-Butylamine and in diluted solutions of alkali hydroxides. Practically insoluble in Ether, in Chloroform and in diluted mineral acids. Captopril is designated chemically as 1-[(2S)-3-Mercapto-2-methylpropionyl]-L-proline; Hydrochlorothiazide is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Their structural formulas are. Captopril and hydrochlorothiazide tablets are available for oral administration in four combinations of captopril with hydrochlorothiazide: 25 mg with 15 mg, 25 mg with 25 mg, 50 mg with 15 mg, and 50 mg with 25 mg. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The 25 mg/25 mg and 50 mg/25 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>16714-829-01</NDCCode>
<PackageDescription>100 CAPSULE, COATED PELLETS in 1 BOTTLE (16714-829-01) </PackageDescription>
<NDC11Code>16714-0829-01</NDC11Code>
<ProductNDC>16714-829</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Budesonide</ProprietaryName>
<NonProprietaryName>Budesonide</NonProprietaryName>
<DosageFormName>CAPSULE, COATED PELLETS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180625</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206134</ApplicationNumber>
<LabelerName>Northstar Rx LLC.</LabelerName>
<SubstanceName>BUDESONIDE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180625</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Budesonide delayed-release capsules are corticosteroid indicated for: 1 Treatment of mild to moderate active Crohn's disease involving the ileum and/or the ascending colon, in patients 8 years and older. (1.1), 2 Maintenance of clinical remission of mild to moderate Crohn's disease involving the ileum and/or the ascending colon for up to 3 months in adults. (1.2).</IndicationAndUsage>
<Description>Budesonide USP, the active ingredient of budesonide delayed-release capsules, is a synthetic corticosteroid. Budesonide is designated chemically as (RS)-11β, 16α, 17,21- tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The molecular formula of budesonide is C25H34O6 and its molecular weight is 430.5. Its structural formula is:. Budesonide, USP is a white to off-white, odorless, crystalline powder that is practically insoluble in water and heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 5 is 1.6 x 103ionic strength 0.01. Each capsule for oral administration contains 3 mg of micronized budesonide with the following inactive ingredients: acetyltributyl citrate, ethylcellulose aqueous dispersion, gelatin, iron oxide red, iron oxide yellow, methacrylic acid copolymer dispersion, polysorbate 80, simethicone emulsion, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide and triethyl citrate. The capsule shell is printed with black pharmaceutical ink which contains following ingredients: iron oxide black, potassium hydroxide, propylene glycol and shellac.</Description>
</NDC>
<NDC>
<NDCCode>21695-829-40</NDCCode>
<PackageDescription>40 g in 1 TUBE (21695-829-40)</PackageDescription>
<NDC11Code>21695-0829-40</NDC11Code>
<ProductNDC>21695-829</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluorouracil</ProprietaryName>
<NonProprietaryName>Fluorouracil</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080411</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077524</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>FLUOROURACIL</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Fluorouracil Cream is recommended for the topical treatment of multiple actinic or solar keratoses. In the 5% strength it is also useful in the treatment of superficial basal cell carcinomas when conventional methods are impractical, such as with multiple lesions or difficult treatment sites. Safety and efficacy in other indications have not been established. The diagnosis should be established prior to treatment, since this method has not been proven effective in other types of basal cell carcinomas. With isolated, easily accessible basal cell carcinomas, surgery is preferred since success with such lesions is almost 100%. The success rate with Fluorouracil Cream is approximately 93%, based on 113 lesions in 54 patients. Eighty-eight lesions treated with the cream produced 7 failures.</IndicationAndUsage>
<Description>Fluorouracil Cream, USP 5% is a topical preparation containing the fluorinated pyrimidine 5-fluorouracil, an antineoplastic antimetabolite. Fluorouracil Cream contains 5% fluorouracil in a vanishing cream base consisting of purified water, white petrolatum, cetyl alcohol, stearyl alcohol, propylene glycol, polysorbate 60 and parabens (methyl and propyl). Chemically, fluorouracil is 5-fluoro-2,4(1H,3H)-pyrimidinedione. It is a white to practically white, crystalline powder which is sparingly soluble in water and slightly soluble in alcohol. One gram of fluorouracil is soluble in 100 mL of propylene glycol. The molecular weight of 5-fluorouracil is 130.08 and the structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>25021-829-02</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (25021-829-02) / 1.5 mL in 1 VIAL</PackageDescription>
<NDC11Code>25021-0829-02</NDC11Code>
<ProductNDC>25021-829</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fomepizole</ProprietaryName>
<NonProprietaryName>Fomepizole</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20231115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216791</ApplicationNumber>
<LabelerName>Sagent Pharmaceuticals</LabelerName>
<SubstanceName>FOMEPIZOLE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>g/1.5mL</StrengthUnit>
<Pharm_Classes>Antidote [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fomepizole injection is indicated as an antidote for ethylene glycol (such as antifreeze) or methanol poisoning, or for use in suspected ethylene glycol or methanol ingestion, either alone or in combination with hemodialysis (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Fomepizole Injection is intended for intravenous use. Fomepizole Injection is a competitive inhibitor of alcohol dehydrogenase. The chemical name of fomepizole is 4-methylpyrazole. It has the molecular formula C4H6N2 and a molecular weight of 82.1. The structural formula is:. It is a clear to yellow liquid at room temperature. Its melting point is 25°C (77°F) and it may present as solid at room temperature. Fomepizole is soluble in water and very soluble in ethanol, diethyl ether, and chloroform. Each vial contains 1.5 mL (1 gram per mL) of fomepizole.</Description>
</NDC>
<NDC>
<NDCCode>31722-829-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (31722-829-01) </PackageDescription>
<NDC11Code>31722-0829-01</NDC11Code>
<ProductNDC>31722-829</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aripiprazole</ProprietaryName>
<NonProprietaryName>Aripiprazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150428</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205064</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ARIPIPRAZOLE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150428</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aripiprazole oral tablets are indicated for the treatment of: 1 Schizophrenia , 2 Treatment of Tourette’s Disorder .</IndicationAndUsage>
<Description>Aripiprazole is a psychotropic drug that is available as aripiprazole tablets. Aripiprazole tablets, USP are chemically designated as 7-[4-[4-(2,3-Dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydro-2(1H)-quinolinone. The molecular formula is C 23H 27C l2N 3O 2, and molecular weight is 448.39. The chemical structure is as follows:. Aripiprazole tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include corn starch, FD&C Blue #2/Indigo Carmine Al, ferric oxide red, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>31722-829-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (31722-829-05) </PackageDescription>
<NDC11Code>31722-0829-05</NDC11Code>
<ProductNDC>31722-829</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aripiprazole</ProprietaryName>
<NonProprietaryName>Aripiprazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150428</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205064</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ARIPIPRAZOLE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aripiprazole oral tablets are indicated for the treatment of: 1 Schizophrenia , 2 Treatment of Tourette’s Disorder .</IndicationAndUsage>
<Description>Aripiprazole is a psychotropic drug that is available as aripiprazole tablets. Aripiprazole tablets, USP are chemically designated as 7-[4-[4-(2,3-Dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydro-2(1H)-quinolinone. The molecular formula is C 23H 27C l2N 3O 2, and molecular weight is 448.39. The chemical structure is as follows:. Aripiprazole tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include corn starch, FD&C Blue #2/Indigo Carmine Al, ferric oxide red, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>31722-829-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (31722-829-30) </PackageDescription>
<NDC11Code>31722-0829-30</NDC11Code>
<ProductNDC>31722-829</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aripiprazole</ProprietaryName>
<NonProprietaryName>Aripiprazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150428</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205064</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ARIPIPRAZOLE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150428</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aripiprazole oral tablets are indicated for the treatment of: 1 Schizophrenia , 2 Treatment of Tourette’s Disorder .</IndicationAndUsage>
<Description>Aripiprazole is a psychotropic drug that is available as aripiprazole tablets. Aripiprazole tablets, USP are chemically designated as 7-[4-[4-(2,3-Dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydro-2(1H)-quinolinone. The molecular formula is C 23H 27C l2N 3O 2, and molecular weight is 448.39. The chemical structure is as follows:. Aripiprazole tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include corn starch, FD&C Blue #2/Indigo Carmine Al, ferric oxide red, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>31722-829-31</NDCCode>
<PackageDescription>10 TABLET in 1 BLISTER PACK (31722-829-31) </PackageDescription>
<NDC11Code>31722-0829-31</NDC11Code>
<ProductNDC>31722-829</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aripiprazole</ProprietaryName>
<NonProprietaryName>Aripiprazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150428</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205064</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ARIPIPRAZOLE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150428</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aripiprazole oral tablets are indicated for the treatment of: 1 Schizophrenia , 2 Treatment of Tourette’s Disorder .</IndicationAndUsage>
<Description>Aripiprazole is a psychotropic drug that is available as aripiprazole tablets. Aripiprazole tablets, USP are chemically designated as 7-[4-[4-(2,3-Dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydro-2(1H)-quinolinone. The molecular formula is C 23H 27C l2N 3O 2, and molecular weight is 448.39. The chemical structure is as follows:. Aripiprazole tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include corn starch, FD&C Blue #2/Indigo Carmine Al, ferric oxide red, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>31722-829-32</NDCCode>
<PackageDescription>250 TABLET in 1 CARTON (31722-829-32) </PackageDescription>
<NDC11Code>31722-0829-32</NDC11Code>
<ProductNDC>31722-829</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aripiprazole</ProprietaryName>
<NonProprietaryName>Aripiprazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150428</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205064</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ARIPIPRAZOLE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150428</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aripiprazole oral tablets are indicated for the treatment of: 1 Schizophrenia , 2 Treatment of Tourette’s Disorder .</IndicationAndUsage>
<Description>Aripiprazole is a psychotropic drug that is available as aripiprazole tablets. Aripiprazole tablets, USP are chemically designated as 7-[4-[4-(2,3-Dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydro-2(1H)-quinolinone. The molecular formula is C 23H 27C l2N 3O 2, and molecular weight is 448.39. The chemical structure is as follows:. Aripiprazole tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include corn starch, FD&C Blue #2/Indigo Carmine Al, ferric oxide red, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>33261-829-30</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (33261-829-30)</PackageDescription>
<NDC11Code>33261-0829-30</NDC11Code>
<ProductNDC>33261-829</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19991228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075116</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>240</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Diltiazem Hydrochloride Extended-release Capsules (Once-a-Day Dosage) are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem Hydrochloride Extended-release Capsules (Once-a-Day Dosage) are indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
<Description>Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one,3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The structural formula is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol and chloroform. It has a molecular weight of 450.98. Diltiazem Hydrochloride Extended-release Capsule (Once-a-Day Dosage), is formulated as a once-a-day extended-release capsule containing 120 mg, 180 mg, 240 mg, or 300 mg diltiazem hydrochloride. Also contains: D&C Yellow #10, FD&C Green #3, gelatin, hypromellose, magnesium stearate, microcrystalline cellulose, polyacrylate dispersion 30%, polysorbate, povidone, simethicone, sucrose stearate, talc, and titanium dioxide. Diltiazem Hydrochloride Extended-release Capsule meets USP Dissolution Test 12. For oral administration.</Description>
</NDC>
<NDC>
<NDCCode>42291-829-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (42291-829-50) </PackageDescription>
<NDC11Code>42291-0829-50</NDC11Code>
<ProductNDC>42291-829</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trazodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Trazodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200417</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071525</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>TRAZODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200417</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults.</IndicationAndUsage>
<Description>Trazodone Hydrochloride Tablets, USP for oral administration contain trazodone hydrochloride, a selective serotonin reuptake inhibitor and 5HT2 receptor antagonist. Trazodone hydrochloride, USP is a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-1,2,4-triazolo[4, 3-a]pyridin-3(2 H)-one hydrochloride. It is a white, odorless crystalline powder which is freely soluble in water. The structural formula is represented as follows:. C 19H 22CIN 5O HCl M.W. 408.33. Each tablet, for oral administration, contains 50 mg, 100 mg or 150 mg of trazodone hydrochloride, USP. In addition, each tablet contains colloidal silicon dioxide, lactose anhydrous, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>42291-829-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (42291-829-90) </PackageDescription>
<NDC11Code>42291-0829-90</NDC11Code>
<ProductNDC>42291-829</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trazodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Trazodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200417</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071525</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>TRAZODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200417</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults.</IndicationAndUsage>
<Description>Trazodone Hydrochloride Tablets, USP for oral administration contain trazodone hydrochloride, a selective serotonin reuptake inhibitor and 5HT2 receptor antagonist. Trazodone hydrochloride, USP is a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-1,2,4-triazolo[4, 3-a]pyridin-3(2 H)-one hydrochloride. It is a white, odorless crystalline powder which is freely soluble in water. The structural formula is represented as follows:. C 19H 22CIN 5O HCl M.W. 408.33. Each tablet, for oral administration, contains 50 mg, 100 mg or 150 mg of trazodone hydrochloride, USP. In addition, each tablet contains colloidal silicon dioxide, lactose anhydrous, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>43353-829-60</NDCCode>
<PackageDescription>90 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43353-829-60) </PackageDescription>
<NDC11Code>43353-0829-60</NDC11Code>
<ProductNDC>43353-829</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omeprazole</ProprietaryName>
<NonProprietaryName>Omeprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090123</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075410</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>OMEPRAZOLE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130325</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Omeprazole Delayed-Release Capsules is a proton pump inhibitor indicated for: 1 Treatment in adults of duodenal ulcer (1.1) and gastric ulcer (1.2)., 2 Treatment in adults and children of gastroesophageal reflux disease (GERD) (1.3) and maintenance of healing of erosive esophagitis (1.4).</IndicationAndUsage>
<Description>The active ingredient in Omeprazole Delayed-Release Capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole Delayed-Release Capsules meet USP Dissolution Test 2. Omeprazole Delayed-Release Capsules is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg, or 40 mg of omeprazole in the form of enteric-coated microtablets with the following inactive ingredients: crospovidone, glyceryl behenate, hypromellose, lactose monohydrate, methacrylic acid copolymer dispersion, silicon dioxide, talc, titanium dioxide and triethyl citrate. In addition, the capsule shells contain gelatin and may contain sodium lauryl sulfate. In addition, the 20 mg and 40 mg capsule shells also contain yellow iron oxide. The imprinting ink also contains ammonium hydroxide, butyl alcohol, black iron oxide, isopropyl alcohol, propylene glycol and shellac glaze. The ink may also contain dehydrated alcohol.</Description>
</NDC>
<NDC>
<NDCCode>43353-829-80</NDCCode>
<PackageDescription>180 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43353-829-80) </PackageDescription>
<NDC11Code>43353-0829-80</NDC11Code>
<ProductNDC>43353-829</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omeprazole</ProprietaryName>
<NonProprietaryName>Omeprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090123</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075410</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>OMEPRAZOLE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201111</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Omeprazole Delayed-Release Capsules is a proton pump inhibitor indicated for: 1 Treatment in adults of duodenal ulcer (1.1) and gastric ulcer (1.2)., 2 Treatment in adults and children of gastroesophageal reflux disease (GERD) (1.3) and maintenance of healing of erosive esophagitis (1.4).</IndicationAndUsage>
<Description>The active ingredient in Omeprazole Delayed-Release Capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole Delayed-Release Capsules meet USP Dissolution Test 2. Omeprazole Delayed-Release Capsules is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg, or 40 mg of omeprazole in the form of enteric-coated microtablets with the following inactive ingredients: crospovidone, glyceryl behenate, hypromellose, lactose monohydrate, methacrylic acid copolymer dispersion, silicon dioxide, talc, titanium dioxide and triethyl citrate. In addition, the capsule shells contain gelatin and may contain sodium lauryl sulfate. In addition, the 20 mg and 40 mg capsule shells also contain yellow iron oxide. The imprinting ink also contains ammonium hydroxide, butyl alcohol, black iron oxide, isopropyl alcohol, propylene glycol and shellac glaze. The ink may also contain dehydrated alcohol.</Description>
</NDC>
<NDC>
<NDCCode>43742-0829-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (43742-0829-1) </PackageDescription>
<NDC11Code>43742-0829-01</NDC11Code>
<ProductNDC>43742-0829</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mucous Membrane Core Formula</ProprietaryName>
<NonProprietaryName>Ceanothus Americanus, Veratrum Album, Anacardium Orientale, Argentum Nitricum, Condurango, Hydrastis Canadensis, Momordica Balsamina, Oxalis Acetosella, Pulsatilla (vulgaris), Bile Duct (suis), Colon (suis), Duodenum (suis), Esophagus (suis), Eye (suis), Gallbladder (suis), Ileum (suis), Intestine (suis), Ipecacuanha, Jejunum (suis), Kali Bichromicum, Lung (suis), Mucosa Nasalis Suis, Natrum Oxalaceticum, Oral Mucosa (suis), Pancreas Suis, Phosphorus, Rectal Mucosa (suis), Stomach (suis), Sulphur</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160817</StartMarketingDate>
<EndMarketingDate>20220307</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Deseret Biologicals, Inc.</LabelerName>
<SubstanceName>ATROPA BELLADONNA; CEANOTHUS AMERICANUS LEAF; GOLDENSEAL; IPECAC; LACHESIS MUTA VENOM; MANDRAGORA OFFICINARUM ROOT; MARSDENIA CONDURANGO BARK; MOMORDICA BALSAMINA IMMATURE FRUIT; OXALIS ACETOSELLA LEAF; PHOSPHORUS; PORK INTESTINE; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SEMECARPUS ANACARDIUM JUICE; SHIGELLA DYSENTERIAE; SILVER NITRATE; SODIUM DIETHYL OXALACETATE; SULFUR; SUS SCROFA BILE DUCT; SUS SCROFA COLON; SUS SCROFA DUODENUM; SUS SCROFA ESOPHAGUS; SUS SCROFA EYE; SUS SCROFA GALLBLADDER; SUS SCROFA ILEUM; SUS SCROFA JEJUNUM; SUS SCROFA LARGE INTESTINE; SUS SCROFA LUNG; SUS SCROFA NASAL MUCOSA; SUS SCROFA ORAL MUCOSA; SUS SCROFA PANCREAS; SUS SCROFA RECTAL MUCOSA; SUS SCROFA STOMACH; SUS SCROFA URINARY BLADDER; VERATRUM ALBUM ROOT; WOOD CREOSOTE; YEAST MANNAN</SubstanceName>
<StrengthNumber>10; 4; 6; 8; 10; 10; 6; 6; 6; 8; 8; 8; 6; 6; 30; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 6; 4; 10; 8</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-03-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160817</StartMarketingDatePackage>
<EndMarketingDatePackage>20220307</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>