{
"NDC": [
{
"NDCCode": "63739-689-10",
"PackageDescription": "10 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-689-10) > 10 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "63739-0689-10",
"ProductNDC": "63739-689",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20091124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078428",
"LabelerName": "McKesson Corporation dba SKY Packaging",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2020-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20140911",
"SamplePackage": "N"
},
{
"NDCCode": "23155-689-41",
"PackageDescription": "10 VIAL, GLASS in 1 CARTON (23155-689-41) / 1 mL in 1 VIAL, GLASS (23155-689-31) ",
"NDC11Code": "23155-0689-41",
"ProductNDC": "23155-689",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Octreotide Acetate",
"NonProprietaryName": "Octreotide Acetate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20220525",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204669",
"LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
"SubstanceName": "OCTREOTIDE ACETATE",
"StrengthNumber": "500",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2024-12-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220525",
"SamplePackage": "N",
"Description": "Octreotide acetate injection, a cyclic octapeptide prepared as a clear sterile solution of octreotide, acetate salt, in a buffered acetic acid solution for administration by deep subcutaneous or IV injection. Octreotide acetate, known chemically as L-Cysteinamide, D-phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-[2-hydroxy-1-(hydroxymethyl) propyl]-,cyclic (2 → 7)-disulfide; [R-(R*, R*)] acetate salt, is a long-acting octapeptide with pharmacologic actions mimicking those of the natural hormone somatostatin. Octreotide acetate injection is available as sterile 1-mL single dose vials in 3 strengths, each mL containing 50 mcg, 100 mcg, or 500 mcg octreotide acetate, USP as the active ingredient and sterile 5-mL multi-dose vials in 2 strengths, containing 200 and 1,000 mcg/mL of octreotide acetate, USP as the active ingredient. Each mL of the single-dose vials also contains following inactive ingredients:glacial acetic acid, USP.......................................................................................................................................2 mgsodium acetate (trihydrate), USP........................................................................................................................2 mgsodium chloride, USP.........................................................................................................................................7 mgwater for injection........................................................................................................... quantity sufficient to 1 mL. Each mL of the multi-dose vials also contains following inactive ingredients:glacial acetic acid, USP......................................................................................................................................2 mgsodium acetate (trihydrate), USP........................................................................................................................2 mgsodium chloride, USP.........................................................................................................................................7 mgphenol, USP .......................................................................................................................................................5 mgwater for injection............................................................................................................ quantity sufficient to 1 mL. Glacial acetic acid, USP and sodium acetate (trihydrate), USP are added to provide a buffered solution, pH to 3.9 to 4.5.The molecular weight of octreotide acetate is 1019.3 g/mol (free peptide, C49H66N10O10S2) and its amino acid sequence is."
},
{
"NDCCode": "25021-689-10",
"PackageDescription": "25 VIAL in 1 CARTON (25021-689-10) / 10 mL in 1 VIAL",
"NDC11Code": "25021-0689-10",
"ProductNDC": "25021-689",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
"NonProprietaryName": "Methocarbamol",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20251001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211504",
"LabelerName": "Sagent Pharmaceuticals",
"SubstanceName": "METHOCARBAMOL",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251001",
"SamplePackage": "N",
"IndicationAndUsage": "The injectable form of methocarbamol is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.",
"Description": "Methocarbamol Injection, USP a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. It is a sterile, pyrogen-free solution intended for intramuscular or intravenous administration. Each mL contains: methocarbamol, USP 100 mg, polyethylene glycol 300, NF 0.5 mL, Water for Injection, USP q.s. The pH is adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide. The chemical name of methocarbamol is 3-(2-methoxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula of C11H15NO5. Its molecular weight is 241.24. The structural formula is shown below:. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Methocarbamol Injection, USP has a pH between 3.5 and 6.0. AFTER MIXING WITH INTRAVENOUS INFUSION FLUIDS, DO NOT REFRIGERATE."
},
{
"NDCCode": "35000-689-10",
"PackageDescription": "1 TUBE in 1 CARTON (35000-689-10) / 113 g in 1 TUBE",
"NDC11Code": "35000-0689-10",
"ProductNDC": "35000-689",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hello Vitamin C Whitening",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20240101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "Colgate-Palmolive Company",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240101",
"SamplePackage": "N",
"IndicationAndUsage": "helps protect against cavities."
},
{
"NDCCode": "43547-689-10",
"PackageDescription": "100 TABLET in 1 BOTTLE (43547-689-10) ",
"NDC11Code": "43547-0689-10",
"ProductNDC": "43547-689",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofolxacin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208921",
"LabelerName": "Solco Healthcare US, LLC",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]",
"Status": "Active",
"LastUpdate": "2025-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231001",
"SamplePackage": "N",
"IndicationAndUsage": "Ciprofloxacin is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: 1 Skin and Skin Structure Infections (1.1), 2 Bone and Joint Infections (1.2), 3 Complicated Intra-Abdominal Infections (1.3), 4 Infectious Diarrhea (1.4), 5 Typhoid Fever (Enteric Fever) (1.5), 6 Uncomplicated Cervical and Urethral Gonorrhea (1.6), 7 Inhalational Anthrax post-exposure in adult and pediatric patients (1.7), 8 Plague in adult and pediatric patients (1.8), 9 Chronic Bacterial Prostatitis (1.9), 10 Lower Respiratory Tract Infections (1.10), 11 oAcute Exacerbation of Chronic Bronchitis, 12 Urinary Tract Infections (1.11), 13 oUrinary Tract Infections (UTI), 14 oAcute Uncomplicated Cystitis, 15 oComplicated UTI and Pyelonephritis in Pediatric Patients, 16 Acute Sinusitis (1.12).",
"Description": "Ciprofloxacin Tablets, USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl- 6-fluoro- 1,4-dihydro- 4-oxo- 7-(1-piperazinyl)- 3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its empirical formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin is 1-cyclopropyl- 6-fluoro- 1,4-dihydro- 4-oxo- 7-(1-piperazinyl)- 3-quinolinecarboxylic acid. Its empirical formula is C17H18FN3O3 and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 250 mg and 500 mg (ciprofloxacin equivalent) strengths. Ciprofloxacin Tablets, USP are white. The inactive ingredients are colloidal silicon dioxide, corn starch, partially pregelatinized maize starch, magnesium stearate, microcrystalline cellulose, sodium starch glycolate (starch from non-GMO potatoes), hypromellose, titanium dioxide and PEG."
},
{
"NDCCode": "60760-689-10",
"PackageDescription": "10 TABLET in 1 BOTTLE, PLASTIC (60760-689-10) ",
"NDC11Code": "60760-0689-10",
"ProductNDC": "60760-689",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofolxacin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20241010",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208921",
"LabelerName": "ST. MARY'S MEDICAL PARK PHARMACY",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241205",
"SamplePackage": "N",
"IndicationAndUsage": "Ciprofloxacin is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: 1 Skin and Skin Structure Infections ( 1.1) , 2 Bone and Joint Infections ( 1.2) , 3 Complicated Intra-Abdominal Infections ( 1.3) , 4 Infectious Diarrhea ( 1.4) , 5 Typhoid Fever (Enteric Fever) ( 1.5) , 6 Uncomplicated Cervical and Urethral Gonorrhea ( 1.6) , 7 Inhalational Anthrax post-exposure in adult and pediatric patients ( 1.7) , 8 Plague in adult and pediatric patients ( 1.8) , 9 Chronic Bacterial Prostatitis ( 1.9) , 10 Lower Respiratory Tract Infections ( 1.10) , 11 Acute Exacerbation of Chronic Bronchitis, 12 Urinary Tract Infections ( 1.11) , 13 Urinary Tract Infections (UTI), 14 Acute Uncomplicated Cystitis, 15 Complicated UTI and Pyelonephritis in Pediatric Patients, 16 Acute Sinusitis ( 1.12) .",
"Description": "Ciprofloxacin Tablets, USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl- 6-fluoro- 1,4-dihydro- 4-oxo- 7-(1-piperazinyl)- 3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its empirical formula is C 17H 18FN 3O 3HClH 2O and its chemical structure is as follows:. Ciprofloxacin is 1-cyclopropyl- 6-fluoro- 1,4-dihydro- 4-oxo- 7-(1-piperazinyl)- 3-quinolinecarboxylic acid. Its empirical formula is C17H18FN3O3 and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 250 mg and 500 mg (ciprofloxacin equivalent) strengths. Ciprofloxacin Tablets, USP are white. The inactive ingredients are colloidal silicon dioxide, corn starch, partially pregelatinized maize starch, magnesium stearate, microcrystalline cellulose, sodium starch glycolate (starch from non-GMO potatoes), hypromellose, titanium dioxide and PEG."
},
{
"NDCCode": "63354-689-10",
"PackageDescription": "3629 g in 1 BOTTLE (63354-689-10) ",
"NDC11Code": "63354-0689-10",
"ProductNDC": "63354-689",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Banana Boat Ultra Sport Sunscreen Broad Spectrum Spf 50",
"NonProprietaryName": "Avobenzone,homosalate,octisalate,octocrylene",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20191119",
"EndMarketingDate": "20261001",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Edgewell Personal Care Brands LLC",
"SubstanceName": "OCTOCRYLENE; AVOBENZONE; HOMOSALATE; OCTISALATE",
"StrengthNumber": "6.5; 2.7; 9; 4.5",
"StrengthUnit": "g/100g; g/100g; g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2026-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20191119",
"EndMarketingDatePackage": "20261001",
"SamplePackage": "N",
"IndicationAndUsage": " helps prevent sunburn if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "66993-689-38",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (66993-689-38) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (66993-689-51) ",
"NDC11Code": "66993-0689-38",
"ProductNDC": "66993-689",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20140515",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203708",
"LabelerName": "Prasco Laboratories",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20140515",
"SamplePackage": "N"
},
{
"NDCCode": "68382-689-10",
"PackageDescription": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-689-10) ",
"NDC11Code": "68382-0689-10",
"ProductNDC": "68382-689",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nifedipine",
"NonProprietaryName": "Nifedipine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180818",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210184",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "NIFEDIPINE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Active",
"LastUpdate": "2024-01-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180818",
"SamplePackage": "N",
"IndicationAndUsage": "Nifedipine extended-release tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.",
"Description": "Nifedipine extended-release tablet, USP is an extended release tablet dosage form of the calcium channel blocker nifedipine. Nifedipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-dimethyl ester, C17H18N2O6, and has the structural formula. Nifedipine USP is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.3. Nifedipine extended-release tablets consist of an external coat and an internal core. Both contain nifedipine, the coat as a slow release formulation and the core as a fast release formulation. Nifedipine extended-release tablets contain either: 30, 60, or 90 mg of nifedipine for once-a-day oral administration. Inert ingredients in the formulation are hydroxypropylcellulose, lactose monohydrate, pregelatinized Starch, crospovidone, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate. The inert ingredients in the film coating for nifedipine extended-release tablets 30 mg and 60 mg are: hypromellose, titanium dioxide, polyethylene glycol, iron oxide yellow and iron oxide red. The inert ingredients in the film coating for nifedipine extended-release tablets 90 mg are hypromellose, titanium dioxide, polyethylene glycol, iron oxide yellow, iron oxide red and ferrosoferic oxide. USP Dissolution Test pending."
},
{
"NDCCode": "68382-689-77",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (68382-689-77) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "68382-0689-77",
"ProductNDC": "68382-689",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nifedipine",
"NonProprietaryName": "Nifedipine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180818",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210184",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "NIFEDIPINE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Active",
"LastUpdate": "2024-01-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180818",
"SamplePackage": "N",
"IndicationAndUsage": "Nifedipine extended-release tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.",
"Description": "Nifedipine extended-release tablet, USP is an extended release tablet dosage form of the calcium channel blocker nifedipine. Nifedipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-dimethyl ester, C17H18N2O6, and has the structural formula. Nifedipine USP is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.3. Nifedipine extended-release tablets consist of an external coat and an internal core. Both contain nifedipine, the coat as a slow release formulation and the core as a fast release formulation. Nifedipine extended-release tablets contain either: 30, 60, or 90 mg of nifedipine for once-a-day oral administration. Inert ingredients in the formulation are hydroxypropylcellulose, lactose monohydrate, pregelatinized Starch, crospovidone, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate. The inert ingredients in the film coating for nifedipine extended-release tablets 30 mg and 60 mg are: hypromellose, titanium dioxide, polyethylene glycol, iron oxide yellow and iron oxide red. The inert ingredients in the film coating for nifedipine extended-release tablets 90 mg are hypromellose, titanium dioxide, polyethylene glycol, iron oxide yellow, iron oxide red and ferrosoferic oxide. USP Dissolution Test pending."
},
{
"NDCCode": "70954-689-10",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (70954-689-10) ",
"NDC11Code": "70954-0689-10",
"ProductNDC": "70954-689",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prochlorperazine Maleate",
"NonProprietaryName": "Prochlorperazine Maleate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216202",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "PROCHLORPERAZINE MALEATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Active",
"LastUpdate": "2026-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220801",
"SamplePackage": "N",
"IndicationAndUsage": "For control of severe nausea and vomiting. For the treatment of schizophrenia. Prochlorperazine is effective for the short-term treatment of generalized non-psychotic anxiety. However, prochlorperazine is not the first drug to be used in therapy for most patients with non-psychotic anxiety, because certain risks associated with its use are not shared by common alternative treatments (e.g., benzodiazepines). When used in the treatment of non-psychotic anxiety, prochlorperazine should not be administered at doses of more than 20 mg per day or for longer than 12 weeks, because the use of prochlorperazine at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see WARNINGS). The effectiveness of prochlorperazine as treatment for non-psychotic anxiety was established in 4-week clinical studies of outpatients with generalized anxiety disorder. This evidence does not predict that prochlorperazine will be useful in patients with other non-psychotic conditions in which anxiety, or signs that mimic anxiety, are found (e.g., physical illness, organic mental conditions, agitated depression, character pathologies, etc.). Prochlorperazine has not been shown effective in the management of behavioral complications in patients with mental retardation.",
"Description": "Prochlorperazine, USP is a phenothiazine derivative, present in prochlorperazine tablets as the maleate. Prochlorperazine maleate is designated chemically as 2-chloro-10-[3-(4-methyl-1-piperazinyl)propyl] phenothiazine maleate [molecular weight 606.10] and has the following structure. Prochlorperazine Maleate is classified as an anti-emetic and antipsychotic agent. Prochlorperazine maleate is white or pale yellow, practically odorless crystalline powder. It is practically insoluble in water and in alcohol, slightly soluble in warm chloroform. Each tablet, for oral administration contains prochlorperazine maleate equivalent to 5 mg or 10 mg of prochlorperazine. In addition, each tablet contains the following inactive ingredients: hypromellose, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, partially pregelatinized maize starch, polyethylene glycol and titanium dioxide. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "10135-689-62",
"PackageDescription": "120 TABLET in 1 BOTTLE (10135-689-62) ",
"NDC11Code": "10135-0689-62",
"ProductNDC": "10135-689",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aspirin 81 Mg Enteric Coated",
"NonProprietaryName": "Aspirin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "Marlex Pharmaceuticals Inc",
"SubstanceName": "ASPIRIN",
"StrengthNumber": "81",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200201",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves minor aches and pains. . For other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur."
},
{
"NDCCode": "13811-689-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (13811-689-30) ",
"NDC11Code": "13811-0689-30",
"ProductNDC": "13811-689",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tramadol Hydrochloride",
"ProprietaryNameSuffix": "Extended-release",
"NonProprietaryName": "Tramadol Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20150622",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA022370",
"LabelerName": "Trigen Laboratories, LLC",
"SubstanceName": "TRAMADOL HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150622",
"SamplePackage": "N",
"IndicationAndUsage": "Tramadol Hydrochloride Extended-Release Capsules are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.",
"Description": "Tramadol Hydrochloride Extended-Release Capsules are an opioid agonist in an extended-release oral formulation. The chemical name for tramadol hydrochloride USP is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. Figure 1. The molecular weight of tramadol hydrochloride USP is 299.8. It is a white, bitter, crystalline and odorless powder that is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol Hydrochloride Extended-Release Capsules contain a total dose of tramadol hydrochloride 100, 200, and 300 mg in a combination of immediate-release and extended-release components. Tramadol Hydrochloride Extended-Release Capsules are white in color. Inactive ingredients include gelatin, titanium dioxide, shellac, FD & C Blue #2 aluminum lake (E132) (100 and 200 mg capsules), D & C Red #7 calcium lake (E180) (200 and 300 mg capsules), D & C Yellow #10 aluminum lake (300 mg capsule), lactose monohydrate 200 mesh, microcrystalline cellulose, povidone K30, corn starch, sodium starch glycolate, magnesium stearate, sucrose stearate, hypromellose, talc, polysorbate 80, Eudragit NE 30D, and simethicone emulsion."
},
{
"NDCCode": "16590-689-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (16590-689-30)",
"NDC11Code": "16590-0689-30",
"ProductNDC": "16590-689",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methadone Hydrochloride",
"NonProprietaryName": "Methadone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19470813",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA006134",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "METHADONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For the treatment of moderate to severe pain not responsive to non-narcotic analgesics. . For detoxification treatment of opioid addiction (heroin or other morphine-like drugs). . For maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services. .",
"Description": "Methadone Hydrochloride Tablets, USP, for oral administration, each contain 5 mg or 10 mg of methadone hydrochloride. Methadone hydrochloride is a white, crystalline material that is water-soluble. Methadone hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-hepatanone hydrochloride. Its molecular formula is C21H27NO · HCl and it has a molecular weight of 345.91. Methadone hydrochloride has a melting point of 235°C, and a pKa of 8.25 in water at 20°C. Its octanol/water partition coefficient at pH 7.4 is 117. A solution (1:100) in water has a pH between 4.5 and 6.5. It has the following structural formula. Other ingredients of Methadone Hydrochloride Tablets include: magnesium stearate, microcrystalline cellulose, and starch."
},
{
"NDCCode": "16590-689-45",
"PackageDescription": "45 TABLET in 1 BOTTLE (16590-689-45)",
"NDC11Code": "16590-0689-45",
"ProductNDC": "16590-689",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methadone Hydrochloride",
"NonProprietaryName": "Methadone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19470813",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA006134",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "METHADONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For the treatment of moderate to severe pain not responsive to non-narcotic analgesics. . For detoxification treatment of opioid addiction (heroin or other morphine-like drugs). . For maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services. .",
"Description": "Methadone Hydrochloride Tablets, USP, for oral administration, each contain 5 mg or 10 mg of methadone hydrochloride. Methadone hydrochloride is a white, crystalline material that is water-soluble. Methadone hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-hepatanone hydrochloride. Its molecular formula is C21H27NO · HCl and it has a molecular weight of 345.91. Methadone hydrochloride has a melting point of 235°C, and a pKa of 8.25 in water at 20°C. Its octanol/water partition coefficient at pH 7.4 is 117. A solution (1:100) in water has a pH between 4.5 and 6.5. It has the following structural formula. Other ingredients of Methadone Hydrochloride Tablets include: magnesium stearate, microcrystalline cellulose, and starch."
},
{
"NDCCode": "16590-689-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (16590-689-60)",
"NDC11Code": "16590-0689-60",
"ProductNDC": "16590-689",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methadone Hydrochloride",
"NonProprietaryName": "Methadone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19470813",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA006134",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "METHADONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For the treatment of moderate to severe pain not responsive to non-narcotic analgesics. . For detoxification treatment of opioid addiction (heroin or other morphine-like drugs). . For maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services. .",
"Description": "Methadone Hydrochloride Tablets, USP, for oral administration, each contain 5 mg or 10 mg of methadone hydrochloride. Methadone hydrochloride is a white, crystalline material that is water-soluble. Methadone hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-hepatanone hydrochloride. Its molecular formula is C21H27NO · HCl and it has a molecular weight of 345.91. Methadone hydrochloride has a melting point of 235°C, and a pKa of 8.25 in water at 20°C. Its octanol/water partition coefficient at pH 7.4 is 117. A solution (1:100) in water has a pH between 4.5 and 6.5. It has the following structural formula. Other ingredients of Methadone Hydrochloride Tablets include: magnesium stearate, microcrystalline cellulose, and starch."
},
{
"NDCCode": "16590-689-72",
"PackageDescription": "120 TABLET in 1 BOTTLE (16590-689-72)",
"NDC11Code": "16590-0689-72",
"ProductNDC": "16590-689",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methadone Hydrochloride",
"NonProprietaryName": "Methadone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19470813",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA006134",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "METHADONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For the treatment of moderate to severe pain not responsive to non-narcotic analgesics. . For detoxification treatment of opioid addiction (heroin or other morphine-like drugs). . For maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services. .",
"Description": "Methadone Hydrochloride Tablets, USP, for oral administration, each contain 5 mg or 10 mg of methadone hydrochloride. Methadone hydrochloride is a white, crystalline material that is water-soluble. Methadone hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-hepatanone hydrochloride. Its molecular formula is C21H27NO · HCl and it has a molecular weight of 345.91. Methadone hydrochloride has a melting point of 235°C, and a pKa of 8.25 in water at 20°C. Its octanol/water partition coefficient at pH 7.4 is 117. A solution (1:100) in water has a pH between 4.5 and 6.5. It has the following structural formula. Other ingredients of Methadone Hydrochloride Tablets include: magnesium stearate, microcrystalline cellulose, and starch."
},
{
"NDCCode": "16590-689-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (16590-689-90)",
"NDC11Code": "16590-0689-90",
"ProductNDC": "16590-689",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methadone Hydrochloride",
"NonProprietaryName": "Methadone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19470813",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA006134",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "METHADONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For the treatment of moderate to severe pain not responsive to non-narcotic analgesics. . For detoxification treatment of opioid addiction (heroin or other morphine-like drugs). . For maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services. .",
"Description": "Methadone Hydrochloride Tablets, USP, for oral administration, each contain 5 mg or 10 mg of methadone hydrochloride. Methadone hydrochloride is a white, crystalline material that is water-soluble. Methadone hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-hepatanone hydrochloride. Its molecular formula is C21H27NO · HCl and it has a molecular weight of 345.91. Methadone hydrochloride has a melting point of 235°C, and a pKa of 8.25 in water at 20°C. Its octanol/water partition coefficient at pH 7.4 is 117. A solution (1:100) in water has a pH between 4.5 and 6.5. It has the following structural formula. Other ingredients of Methadone Hydrochloride Tablets include: magnesium stearate, microcrystalline cellulose, and starch."
},
{
"NDCCode": "42507-689-26",
"PackageDescription": "1 BOTTLE in 1 CARTON (42507-689-26) / 118 mL in 1 BOTTLE (42507-689-00) ",
"NDC11Code": "42507-0689-26",
"ProductNDC": "42507-689",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tussin Dm Nighttime Max",
"NonProprietaryName": "Dextromethorphan Hydrobromide, Doxylamine Succinate",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20260113",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "HyVee Inc",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
"StrengthNumber": "30; 12.5",
"StrengthUnit": "mg/20mL; mg/20mL",
"Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260113",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold. temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:. runny nose. sneezing. itchy, watery eyes. itching of the nose or throat. controls the impulse to cough to help you sleep."
},
{
"NDCCode": "43547-689-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (43547-689-50) ",
"NDC11Code": "43547-0689-50",
"ProductNDC": "43547-689",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofolxacin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208921",
"LabelerName": "Solco Healthcare US, LLC",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]",
"Status": "Active",
"LastUpdate": "2025-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231001",
"SamplePackage": "N",
"IndicationAndUsage": "Ciprofloxacin is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: 1 Skin and Skin Structure Infections (1.1), 2 Bone and Joint Infections (1.2), 3 Complicated Intra-Abdominal Infections (1.3), 4 Infectious Diarrhea (1.4), 5 Typhoid Fever (Enteric Fever) (1.5), 6 Uncomplicated Cervical and Urethral Gonorrhea (1.6), 7 Inhalational Anthrax post-exposure in adult and pediatric patients (1.7), 8 Plague in adult and pediatric patients (1.8), 9 Chronic Bacterial Prostatitis (1.9), 10 Lower Respiratory Tract Infections (1.10), 11 oAcute Exacerbation of Chronic Bronchitis, 12 Urinary Tract Infections (1.11), 13 oUrinary Tract Infections (UTI), 14 oAcute Uncomplicated Cystitis, 15 oComplicated UTI and Pyelonephritis in Pediatric Patients, 16 Acute Sinusitis (1.12).",
"Description": "Ciprofloxacin Tablets, USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl- 6-fluoro- 1,4-dihydro- 4-oxo- 7-(1-piperazinyl)- 3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its empirical formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin is 1-cyclopropyl- 6-fluoro- 1,4-dihydro- 4-oxo- 7-(1-piperazinyl)- 3-quinolinecarboxylic acid. Its empirical formula is C17H18FN3O3 and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 250 mg and 500 mg (ciprofloxacin equivalent) strengths. Ciprofloxacin Tablets, USP are white. The inactive ingredients are colloidal silicon dioxide, corn starch, partially pregelatinized maize starch, magnesium stearate, microcrystalline cellulose, sodium starch glycolate (starch from non-GMO potatoes), hypromellose, titanium dioxide and PEG."
},
{
"NDCCode": "47335-689-08",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (47335-689-08) ",
"NDC11Code": "47335-0689-08",
"ProductNDC": "47335-689",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20191204",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091157",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2024-01-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191204",
"SamplePackage": "N",
"IndicationAndUsage": "Pregabalin capsules are indicated for.",
"Description": "Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is sparingly soluble in water and slightly soluble in methanol. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35.Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, USP, along with lactose monohydrate and talc as inactive ingredients. The capsule shells contain gelatin, iron oxide black (200 mg and 225 mg), iron oxide red (75 mg, 100 mg, 200 mg, 225 mg and 300 mg) sodium lauryl sulfate and titanium dioxide. The imprinting black ink contains black iron oxide, butyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "47335-689-18",
"PackageDescription": "1000 CAPSULE in 1 BOTTLE (47335-689-18) ",
"NDC11Code": "47335-0689-18",
"ProductNDC": "47335-689",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20191204",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091157",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2024-01-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191204",
"SamplePackage": "N",
"IndicationAndUsage": "Pregabalin capsules are indicated for.",
"Description": "Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is sparingly soluble in water and slightly soluble in methanol. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35.Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, USP, along with lactose monohydrate and talc as inactive ingredients. The capsule shells contain gelatin, iron oxide black (200 mg and 225 mg), iron oxide red (75 mg, 100 mg, 200 mg, 225 mg and 300 mg) sodium lauryl sulfate and titanium dioxide. The imprinting black ink contains black iron oxide, butyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "47335-689-83",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (47335-689-83) ",
"NDC11Code": "47335-0689-83",
"ProductNDC": "47335-689",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20191204",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091157",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2024-01-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191204",
"SamplePackage": "N",
"IndicationAndUsage": "Pregabalin capsules are indicated for.",
"Description": "Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is sparingly soluble in water and slightly soluble in methanol. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35.Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, USP, along with lactose monohydrate and talc as inactive ingredients. The capsule shells contain gelatin, iron oxide black (200 mg and 225 mg), iron oxide red (75 mg, 100 mg, 200 mg, 225 mg and 300 mg) sodium lauryl sulfate and titanium dioxide. The imprinting black ink contains black iron oxide, butyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "47335-689-88",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (47335-689-88) ",
"NDC11Code": "47335-0689-88",
"ProductNDC": "47335-689",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20191204",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091157",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2024-01-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191204",
"SamplePackage": "N",
"IndicationAndUsage": "Pregabalin capsules are indicated for.",
"Description": "Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is sparingly soluble in water and slightly soluble in methanol. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35.Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, USP, along with lactose monohydrate and talc as inactive ingredients. The capsule shells contain gelatin, iron oxide black (200 mg and 225 mg), iron oxide red (75 mg, 100 mg, 200 mg, 225 mg and 300 mg) sodium lauryl sulfate and titanium dioxide. The imprinting black ink contains black iron oxide, butyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "49483-689-03",
"PackageDescription": "30 CAPSULE, LIQUID FILLED in 1 BOTTLE (49483-689-03) ",
"NDC11Code": "49483-0689-03",
"ProductNDC": "49483-689",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paricalcitol",
"NonProprietaryName": "Paricalcitol",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20170103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204948",
"LabelerName": "TIME CAP LABORATORIES, INC",
"SubstanceName": "PARICALCITOL",
"StrengthNumber": "4",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Ergocalciferols [CS], Vitamin D2 Analog [EPC]",
"Status": "Active",
"LastUpdate": "2022-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170103",
"SamplePackage": "N",
"IndicationAndUsage": "1.1 Chronic Kidney Disease Stages 3 and 4. Paricalcitol Capsules are indicated in adults for the prevention and treatment of secondary hyperparathyroidism associated with Chronic Kidney Disease (CKD) Stages 3 and 4. Pediatric use information for patients 10 to 16 years of age is approved for AbbVie Inc.’s Zemplar (Paricalcitol) capsules. However, due to AbbVie Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 1.2 Chronic Kidney Disease Stage 5 Paricalcitol Capsules are indicated in adults for the prevention and treatment of secondary hyperparathyroidism associated with CKD Stage 5 in patients on hemodialysis (HD) or peritoneal dialysis (PD). Pediatric use information for patients 10 to 16 years of age is approved for AbbVie Inc.’s Zemplar (Paricalcitol) capsules. However, due to AbbVie Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.",
"Description": "Paricalcitol, USP, the active ingredient in Paricalcitol Capsules, is a synthetically manufactured, metabolically active vitamin D analog of calcitriol with modifications to the side chain (D 2) and the A (19-nor) ring. Paricalcitol is available as soft gelatin capsules for oral administration containing 1 microgram, 2 micrograms, and 4 micrograms of paricalcitol. Each capsule also contains medium chain triglycerides, alcohol, and butylated hydroxytoluene. ..The capsule shell is composed of gelatin, glycerin, Noncrystallizing Sorbitol solution, titanium dioxide, iron oxide red (2 microgram capsules only), iron oxide yellow (2 microgram and 4 microgram capsules), iron oxide black (1 microgram capsules only) and water. The soft gelatin capsules are printed with black ink Opacode Black (S-1-17823) containing Isopropyl alcohol, Black iron oxide, N-Butyl alcohol, Propylene glycol, Ammonium hydroxide and Shellac. Paricalcitol is a white, crystalline powder with the empirical formula of C 27H 44O 3, which corresponds to a molecular weight of 416.64. Paricalcitol is chemically designated as 19-nor-1α,3β,25-trihydroxy-9,10-secoergosta-5(Z),7(E),22(E)- triene and has the following structural formula:."
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{
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"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Loreal Paris Revitalift",
"ProprietaryNameSuffix": "Clinical Repair 10 Spf 20",
"NonProprietaryName": "Avobenzone Homosalate Octisalate Octocrylene",
"DosageFormName": "LOTION",
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"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "L'Oreal USA Products Inc",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "1.5; 5; 2.5; 3.5",
"StrengthUnit": "mL/50mL; mL/50mL; mL/50mL; mL/50mL",
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"ProductNdcExcludeFlag": "E",
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{
"NDCCode": "50268-689-15",
"PackageDescription": "50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-689-15) > 1 TABLET in 1 BLISTER PACK (50268-689-11)",
"NDC11Code": "50268-0689-15",
"ProductNDC": "50268-689",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quinapril",
"NonProprietaryName": "Quinapril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078457",
"LabelerName": "AvPAK",
"SubstanceName": "QUINAPRIL HYDROCHLORIDE",
"StrengthNumber": "10",
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"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]",
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},
{
"NDCCode": "53031-011-01",
"PackageDescription": "985 mL in 1 BOTTLE (53031-011-01) ",
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"ApplicationNumber": "part333A",
"LabelerName": "Dongyang Medical & Hygienic Articles Co., Ltd.",
"SubstanceName": "ALCOHOL",
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"LastUpdate": "2020-10-14",
"PackageNdcExcludeFlag": "N",
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<NonProprietaryName>Octreotide Acetate</NonProprietaryName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204669</ApplicationNumber>
<LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
<SubstanceName>OCTREOTIDE ACETATE</SubstanceName>
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<StrengthUnit>ug/mL</StrengthUnit>
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<Description>Octreotide acetate injection, a cyclic octapeptide prepared as a clear sterile solution of octreotide, acetate salt, in a buffered acetic acid solution for administration by deep subcutaneous or IV injection. Octreotide acetate, known chemically as L-Cysteinamide, D-phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-[2-hydroxy-1-(hydroxymethyl) propyl]-,cyclic (2 → 7)-disulfide; [R-(R*, R*)] acetate salt, is a long-acting octapeptide with pharmacologic actions mimicking those of the natural hormone somatostatin. Octreotide acetate injection is available as sterile 1-mL single dose vials in 3 strengths, each mL containing 50 mcg, 100 mcg, or 500 mcg octreotide acetate, USP as the active ingredient and sterile 5-mL multi-dose vials in 2 strengths, containing 200 and 1,000 mcg/mL of octreotide acetate, USP as the active ingredient. Each mL of the single-dose vials also contains following inactive ingredients:glacial acetic acid, USP.......................................................................................................................................2 mgsodium acetate (trihydrate), USP........................................................................................................................2 mgsodium chloride, USP.........................................................................................................................................7 mgwater for injection........................................................................................................... quantity sufficient to 1 mL. Each mL of the multi-dose vials also contains following inactive ingredients:glacial acetic acid, USP......................................................................................................................................2 mgsodium acetate (trihydrate), USP........................................................................................................................2 mgsodium chloride, USP.........................................................................................................................................7 mgphenol, USP .......................................................................................................................................................5 mgwater for injection............................................................................................................ quantity sufficient to 1 mL. Glacial acetic acid, USP and sodium acetate (trihydrate), USP are added to provide a buffered solution, pH to 3.9 to 4.5.The molecular weight of octreotide acetate is 1019.3 g/mol (free peptide, C49H66N10O10S2) and its amino acid sequence is.</Description>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20251001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211504</ApplicationNumber>
<LabelerName>Sagent Pharmaceuticals</LabelerName>
<SubstanceName>METHOCARBAMOL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<IndicationAndUsage>The injectable form of methocarbamol is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.</IndicationAndUsage>
<Description>Methocarbamol Injection, USP a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. It is a sterile, pyrogen-free solution intended for intramuscular or intravenous administration. Each mL contains: methocarbamol, USP 100 mg, polyethylene glycol 300, NF 0.5 mL, Water for Injection, USP q.s. The pH is adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide. The chemical name of methocarbamol is 3-(2-methoxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula of C11H15NO5. Its molecular weight is 241.24. The structural formula is shown below:. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Methocarbamol Injection, USP has a pH between 3.5 and 6.0. AFTER MIXING WITH INTRAVENOUS INFUSION FLUIDS, DO NOT REFRIGERATE.</Description>
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<NDC>
<NDCCode>35000-689-10</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (35000-689-10) / 113 g in 1 TUBE</PackageDescription>
<NDC11Code>35000-0689-10</NDC11Code>
<ProductNDC>35000-689</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hello Vitamin C Whitening</ProprietaryName>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>PASTE, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
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<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M021</ApplicationNumber>
<LabelerName>Colgate-Palmolive Company</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
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<StrengthUnit>mg/g</StrengthUnit>
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<IndicationAndUsage>helps protect against cavities.</IndicationAndUsage>
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<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]</Pharm_Classes>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<IndicationAndUsage>Ciprofloxacin is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: 1 Skin and Skin Structure Infections (1.1), 2 Bone and Joint Infections (1.2), 3 Complicated Intra-Abdominal Infections (1.3), 4 Infectious Diarrhea (1.4), 5 Typhoid Fever (Enteric Fever) (1.5), 6 Uncomplicated Cervical and Urethral Gonorrhea (1.6), 7 Inhalational Anthrax post-exposure in adult and pediatric patients (1.7), 8 Plague in adult and pediatric patients (1.8), 9 Chronic Bacterial Prostatitis (1.9), 10 Lower Respiratory Tract Infections (1.10), 11 oAcute Exacerbation of Chronic Bronchitis, 12 Urinary Tract Infections (1.11), 13 oUrinary Tract Infections (UTI), 14 oAcute Uncomplicated Cystitis, 15 oComplicated UTI and Pyelonephritis in Pediatric Patients, 16 Acute Sinusitis (1.12).</IndicationAndUsage>
<Description>Ciprofloxacin Tablets, USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl- 6-fluoro- 1,4-dihydro- 4-oxo- 7-(1-piperazinyl)- 3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its empirical formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin is 1-cyclopropyl- 6-fluoro- 1,4-dihydro- 4-oxo- 7-(1-piperazinyl)- 3-quinolinecarboxylic acid. Its empirical formula is C17H18FN3O3 and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 250 mg and 500 mg (ciprofloxacin equivalent) strengths. Ciprofloxacin Tablets, USP are white. The inactive ingredients are colloidal silicon dioxide, corn starch, partially pregelatinized maize starch, magnesium stearate, microcrystalline cellulose, sodium starch glycolate (starch from non-GMO potatoes), hypromellose, titanium dioxide and PEG.</Description>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin</ProprietaryName>
<NonProprietaryName>Ciprofolxacin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241010</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208921</ApplicationNumber>
<LabelerName>ST. MARY'S MEDICAL PARK PHARMACY</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ciprofloxacin is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: 1 Skin and Skin Structure Infections ( 1.1) , 2 Bone and Joint Infections ( 1.2) , 3 Complicated Intra-Abdominal Infections ( 1.3) , 4 Infectious Diarrhea ( 1.4) , 5 Typhoid Fever (Enteric Fever) ( 1.5) , 6 Uncomplicated Cervical and Urethral Gonorrhea ( 1.6) , 7 Inhalational Anthrax post-exposure in adult and pediatric patients ( 1.7) , 8 Plague in adult and pediatric patients ( 1.8) , 9 Chronic Bacterial Prostatitis ( 1.9) , 10 Lower Respiratory Tract Infections ( 1.10) , 11 Acute Exacerbation of Chronic Bronchitis, 12 Urinary Tract Infections ( 1.11) , 13 Urinary Tract Infections (UTI), 14 Acute Uncomplicated Cystitis, 15 Complicated UTI and Pyelonephritis in Pediatric Patients, 16 Acute Sinusitis ( 1.12) .</IndicationAndUsage>
<Description>Ciprofloxacin Tablets, USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl- 6-fluoro- 1,4-dihydro- 4-oxo- 7-(1-piperazinyl)- 3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its empirical formula is C 17H 18FN 3O 3HClH 2O and its chemical structure is as follows:. Ciprofloxacin is 1-cyclopropyl- 6-fluoro- 1,4-dihydro- 4-oxo- 7-(1-piperazinyl)- 3-quinolinecarboxylic acid. Its empirical formula is C17H18FN3O3 and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 250 mg and 500 mg (ciprofloxacin equivalent) strengths. Ciprofloxacin Tablets, USP are white. The inactive ingredients are colloidal silicon dioxide, corn starch, partially pregelatinized maize starch, magnesium stearate, microcrystalline cellulose, sodium starch glycolate (starch from non-GMO potatoes), hypromellose, titanium dioxide and PEG.</Description>
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<PackageDescription>3629 g in 1 BOTTLE (63354-689-10) </PackageDescription>
<NDC11Code>63354-0689-10</NDC11Code>
<ProductNDC>63354-689</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Banana Boat Ultra Sport Sunscreen Broad Spectrum Spf 50</ProprietaryName>
<NonProprietaryName>Avobenzone,homosalate,octisalate,octocrylene</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20191119</StartMarketingDate>
<EndMarketingDate>20261001</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Edgewell Personal Care Brands LLC</LabelerName>
<SubstanceName>OCTOCRYLENE; AVOBENZONE; HOMOSALATE; OCTISALATE</SubstanceName>
<StrengthNumber>6.5; 2.7; 9; 4.5</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-10-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20191119</StartMarketingDatePackage>
<EndMarketingDatePackage>20261001</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> helps prevent sunburn if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66993-689-38</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (66993-689-38) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (66993-689-51) </PackageDescription>
<NDC11Code>66993-0689-38</NDC11Code>
<ProductNDC>66993-689</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140515</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203708</ApplicationNumber>
<LabelerName>Prasco Laboratories</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>68382-689-10</NDCCode>
<PackageDescription>1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-689-10) </PackageDescription>
<NDC11Code>68382-0689-10</NDC11Code>
<ProductNDC>68382-689</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nifedipine</ProprietaryName>
<NonProprietaryName>Nifedipine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180818</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210184</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>NIFEDIPINE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180818</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nifedipine extended-release tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Nifedipine extended-release tablet, USP is an extended release tablet dosage form of the calcium channel blocker nifedipine. Nifedipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-dimethyl ester, C17H18N2O6, and has the structural formula. Nifedipine USP is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.3. Nifedipine extended-release tablets consist of an external coat and an internal core. Both contain nifedipine, the coat as a slow release formulation and the core as a fast release formulation. Nifedipine extended-release tablets contain either: 30, 60, or 90 mg of nifedipine for once-a-day oral administration. Inert ingredients in the formulation are hydroxypropylcellulose, lactose monohydrate, pregelatinized Starch, crospovidone, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate. The inert ingredients in the film coating for nifedipine extended-release tablets 30 mg and 60 mg are: hypromellose, titanium dioxide, polyethylene glycol, iron oxide yellow and iron oxide red. The inert ingredients in the film coating for nifedipine extended-release tablets 90 mg are hypromellose, titanium dioxide, polyethylene glycol, iron oxide yellow, iron oxide red and ferrosoferic oxide. USP Dissolution Test pending.</Description>
</NDC>
<NDC>
<NDCCode>68382-689-77</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (68382-689-77) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>68382-0689-77</NDC11Code>
<ProductNDC>68382-689</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nifedipine</ProprietaryName>
<NonProprietaryName>Nifedipine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180818</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210184</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>NIFEDIPINE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180818</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nifedipine extended-release tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Nifedipine extended-release tablet, USP is an extended release tablet dosage form of the calcium channel blocker nifedipine. Nifedipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-dimethyl ester, C17H18N2O6, and has the structural formula. Nifedipine USP is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.3. Nifedipine extended-release tablets consist of an external coat and an internal core. Both contain nifedipine, the coat as a slow release formulation and the core as a fast release formulation. Nifedipine extended-release tablets contain either: 30, 60, or 90 mg of nifedipine for once-a-day oral administration. Inert ingredients in the formulation are hydroxypropylcellulose, lactose monohydrate, pregelatinized Starch, crospovidone, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate. The inert ingredients in the film coating for nifedipine extended-release tablets 30 mg and 60 mg are: hypromellose, titanium dioxide, polyethylene glycol, iron oxide yellow and iron oxide red. The inert ingredients in the film coating for nifedipine extended-release tablets 90 mg are hypromellose, titanium dioxide, polyethylene glycol, iron oxide yellow, iron oxide red and ferrosoferic oxide. USP Dissolution Test pending.</Description>
</NDC>
<NDC>
<NDCCode>70954-689-10</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (70954-689-10) </PackageDescription>
<NDC11Code>70954-0689-10</NDC11Code>
<ProductNDC>70954-689</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prochlorperazine Maleate</ProprietaryName>
<NonProprietaryName>Prochlorperazine Maleate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216202</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PROCHLORPERAZINE MALEATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For control of severe nausea and vomiting. For the treatment of schizophrenia. Prochlorperazine is effective for the short-term treatment of generalized non-psychotic anxiety. However, prochlorperazine is not the first drug to be used in therapy for most patients with non-psychotic anxiety, because certain risks associated with its use are not shared by common alternative treatments (e.g., benzodiazepines). When used in the treatment of non-psychotic anxiety, prochlorperazine should not be administered at doses of more than 20 mg per day or for longer than 12 weeks, because the use of prochlorperazine at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see WARNINGS). The effectiveness of prochlorperazine as treatment for non-psychotic anxiety was established in 4-week clinical studies of outpatients with generalized anxiety disorder. This evidence does not predict that prochlorperazine will be useful in patients with other non-psychotic conditions in which anxiety, or signs that mimic anxiety, are found (e.g., physical illness, organic mental conditions, agitated depression, character pathologies, etc.). Prochlorperazine has not been shown effective in the management of behavioral complications in patients with mental retardation.</IndicationAndUsage>
<Description>Prochlorperazine, USP is a phenothiazine derivative, present in prochlorperazine tablets as the maleate. Prochlorperazine maleate is designated chemically as 2-chloro-10-[3-(4-methyl-1-piperazinyl)propyl] phenothiazine maleate [molecular weight 606.10] and has the following structure. Prochlorperazine Maleate is classified as an anti-emetic and antipsychotic agent. Prochlorperazine maleate is white or pale yellow, practically odorless crystalline powder. It is practically insoluble in water and in alcohol, slightly soluble in warm chloroform. Each tablet, for oral administration contains prochlorperazine maleate equivalent to 5 mg or 10 mg of prochlorperazine. In addition, each tablet contains the following inactive ingredients: hypromellose, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, partially pregelatinized maize starch, polyethylene glycol and titanium dioxide. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>10135-689-62</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE (10135-689-62) </PackageDescription>
<NDC11Code>10135-0689-62</NDC11Code>
<ProductNDC>10135-689</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aspirin 81 Mg Enteric Coated</ProprietaryName>
<NonProprietaryName>Aspirin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals Inc</LabelerName>
<SubstanceName>ASPIRIN</SubstanceName>
<StrengthNumber>81</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves minor aches and pains. . For other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>13811-689-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE, PLASTIC (13811-689-30) </PackageDescription>
<NDC11Code>13811-0689-30</NDC11Code>
<ProductNDC>13811-689</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Extended-release</ProprietaryNameSuffix>
<NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150622</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA022370</ApplicationNumber>
<LabelerName>Trigen Laboratories, LLC</LabelerName>
<SubstanceName>TRAMADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150622</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tramadol Hydrochloride Extended-Release Capsules are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.</IndicationAndUsage>
<Description>Tramadol Hydrochloride Extended-Release Capsules are an opioid agonist in an extended-release oral formulation. The chemical name for tramadol hydrochloride USP is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. Figure 1. The molecular weight of tramadol hydrochloride USP is 299.8. It is a white, bitter, crystalline and odorless powder that is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol Hydrochloride Extended-Release Capsules contain a total dose of tramadol hydrochloride 100, 200, and 300 mg in a combination of immediate-release and extended-release components. Tramadol Hydrochloride Extended-Release Capsules are white in color. Inactive ingredients include gelatin, titanium dioxide, shellac, FD & C Blue #2 aluminum lake (E132) (100 and 200 mg capsules), D & C Red #7 calcium lake (E180) (200 and 300 mg capsules), D & C Yellow #10 aluminum lake (300 mg capsule), lactose monohydrate 200 mesh, microcrystalline cellulose, povidone K30, corn starch, sodium starch glycolate, magnesium stearate, sucrose stearate, hypromellose, talc, polysorbate 80, Eudragit NE 30D, and simethicone emulsion.</Description>
</NDC>
<NDC>
<NDCCode>16590-689-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (16590-689-30)</PackageDescription>
<NDC11Code>16590-0689-30</NDC11Code>
<ProductNDC>16590-689</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methadone Hydrochloride</ProprietaryName>
<NonProprietaryName>Methadone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19470813</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA006134</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>METHADONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For the treatment of moderate to severe pain not responsive to non-narcotic analgesics. . For detoxification treatment of opioid addiction (heroin or other morphine-like drugs). . For maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services. .</IndicationAndUsage>
<Description>Methadone Hydrochloride Tablets, USP, for oral administration, each contain 5 mg or 10 mg of methadone hydrochloride. Methadone hydrochloride is a white, crystalline material that is water-soluble. Methadone hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-hepatanone hydrochloride. Its molecular formula is C21H27NO · HCl and it has a molecular weight of 345.91. Methadone hydrochloride has a melting point of 235°C, and a pKa of 8.25 in water at 20°C. Its octanol/water partition coefficient at pH 7.4 is 117. A solution (1:100) in water has a pH between 4.5 and 6.5. It has the following structural formula. Other ingredients of Methadone Hydrochloride Tablets include: magnesium stearate, microcrystalline cellulose, and starch.</Description>
</NDC>
<NDC>
<NDCCode>16590-689-45</NDCCode>
<PackageDescription>45 TABLET in 1 BOTTLE (16590-689-45)</PackageDescription>
<NDC11Code>16590-0689-45</NDC11Code>
<ProductNDC>16590-689</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methadone Hydrochloride</ProprietaryName>
<NonProprietaryName>Methadone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19470813</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA006134</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>METHADONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For the treatment of moderate to severe pain not responsive to non-narcotic analgesics. . For detoxification treatment of opioid addiction (heroin or other morphine-like drugs). . For maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services. .</IndicationAndUsage>
<Description>Methadone Hydrochloride Tablets, USP, for oral administration, each contain 5 mg or 10 mg of methadone hydrochloride. Methadone hydrochloride is a white, crystalline material that is water-soluble. Methadone hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-hepatanone hydrochloride. Its molecular formula is C21H27NO · HCl and it has a molecular weight of 345.91. Methadone hydrochloride has a melting point of 235°C, and a pKa of 8.25 in water at 20°C. Its octanol/water partition coefficient at pH 7.4 is 117. A solution (1:100) in water has a pH between 4.5 and 6.5. It has the following structural formula. Other ingredients of Methadone Hydrochloride Tablets include: magnesium stearate, microcrystalline cellulose, and starch.</Description>
</NDC>
<NDC>
<NDCCode>16590-689-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (16590-689-60)</PackageDescription>
<NDC11Code>16590-0689-60</NDC11Code>
<ProductNDC>16590-689</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methadone Hydrochloride</ProprietaryName>
<NonProprietaryName>Methadone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19470813</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA006134</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>METHADONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For the treatment of moderate to severe pain not responsive to non-narcotic analgesics. . For detoxification treatment of opioid addiction (heroin or other morphine-like drugs). . For maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services. .</IndicationAndUsage>
<Description>Methadone Hydrochloride Tablets, USP, for oral administration, each contain 5 mg or 10 mg of methadone hydrochloride. Methadone hydrochloride is a white, crystalline material that is water-soluble. Methadone hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-hepatanone hydrochloride. Its molecular formula is C21H27NO · HCl and it has a molecular weight of 345.91. Methadone hydrochloride has a melting point of 235°C, and a pKa of 8.25 in water at 20°C. Its octanol/water partition coefficient at pH 7.4 is 117. A solution (1:100) in water has a pH between 4.5 and 6.5. It has the following structural formula. Other ingredients of Methadone Hydrochloride Tablets include: magnesium stearate, microcrystalline cellulose, and starch.</Description>
</NDC>
<NDC>
<NDCCode>16590-689-72</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE (16590-689-72)</PackageDescription>
<NDC11Code>16590-0689-72</NDC11Code>
<ProductNDC>16590-689</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methadone Hydrochloride</ProprietaryName>
<NonProprietaryName>Methadone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19470813</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA006134</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>METHADONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For the treatment of moderate to severe pain not responsive to non-narcotic analgesics. . For detoxification treatment of opioid addiction (heroin or other morphine-like drugs). . For maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services. .</IndicationAndUsage>
<Description>Methadone Hydrochloride Tablets, USP, for oral administration, each contain 5 mg or 10 mg of methadone hydrochloride. Methadone hydrochloride is a white, crystalline material that is water-soluble. Methadone hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-hepatanone hydrochloride. Its molecular formula is C21H27NO · HCl and it has a molecular weight of 345.91. Methadone hydrochloride has a melting point of 235°C, and a pKa of 8.25 in water at 20°C. Its octanol/water partition coefficient at pH 7.4 is 117. A solution (1:100) in water has a pH between 4.5 and 6.5. It has the following structural formula. Other ingredients of Methadone Hydrochloride Tablets include: magnesium stearate, microcrystalline cellulose, and starch.</Description>
</NDC>
<NDC>
<NDCCode>16590-689-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (16590-689-90)</PackageDescription>
<NDC11Code>16590-0689-90</NDC11Code>
<ProductNDC>16590-689</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methadone Hydrochloride</ProprietaryName>
<NonProprietaryName>Methadone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19470813</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA006134</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>METHADONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For the treatment of moderate to severe pain not responsive to non-narcotic analgesics. . For detoxification treatment of opioid addiction (heroin or other morphine-like drugs). . For maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services. .</IndicationAndUsage>
<Description>Methadone Hydrochloride Tablets, USP, for oral administration, each contain 5 mg or 10 mg of methadone hydrochloride. Methadone hydrochloride is a white, crystalline material that is water-soluble. Methadone hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-hepatanone hydrochloride. Its molecular formula is C21H27NO · HCl and it has a molecular weight of 345.91. Methadone hydrochloride has a melting point of 235°C, and a pKa of 8.25 in water at 20°C. Its octanol/water partition coefficient at pH 7.4 is 117. A solution (1:100) in water has a pH between 4.5 and 6.5. It has the following structural formula. Other ingredients of Methadone Hydrochloride Tablets include: magnesium stearate, microcrystalline cellulose, and starch.</Description>
</NDC>
<NDC>
<NDCCode>42507-689-26</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (42507-689-26) / 118 mL in 1 BOTTLE (42507-689-00) </PackageDescription>
<NDC11Code>42507-0689-26</NDC11Code>
<ProductNDC>42507-689</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tussin Dm Nighttime Max</ProprietaryName>
<NonProprietaryName>Dextromethorphan Hydrobromide, Doxylamine Succinate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260113</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>HyVee Inc</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE</SubstanceName>
<StrengthNumber>30; 12.5</StrengthNumber>
<StrengthUnit>mg/20mL; mg/20mL</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260113</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold. temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:. runny nose. sneezing. itchy, watery eyes. itching of the nose or throat. controls the impulse to cough to help you sleep.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43547-689-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (43547-689-50) </PackageDescription>
<NDC11Code>43547-0689-50</NDC11Code>
<ProductNDC>43547-689</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin</ProprietaryName>
<NonProprietaryName>Ciprofolxacin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208921</ApplicationNumber>
<LabelerName>Solco Healthcare US, LLC</LabelerName>
<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ciprofloxacin is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: 1 Skin and Skin Structure Infections (1.1), 2 Bone and Joint Infections (1.2), 3 Complicated Intra-Abdominal Infections (1.3), 4 Infectious Diarrhea (1.4), 5 Typhoid Fever (Enteric Fever) (1.5), 6 Uncomplicated Cervical and Urethral Gonorrhea (1.6), 7 Inhalational Anthrax post-exposure in adult and pediatric patients (1.7), 8 Plague in adult and pediatric patients (1.8), 9 Chronic Bacterial Prostatitis (1.9), 10 Lower Respiratory Tract Infections (1.10), 11 oAcute Exacerbation of Chronic Bronchitis, 12 Urinary Tract Infections (1.11), 13 oUrinary Tract Infections (UTI), 14 oAcute Uncomplicated Cystitis, 15 oComplicated UTI and Pyelonephritis in Pediatric Patients, 16 Acute Sinusitis (1.12).</IndicationAndUsage>
<Description>Ciprofloxacin Tablets, USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl- 6-fluoro- 1,4-dihydro- 4-oxo- 7-(1-piperazinyl)- 3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its empirical formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin is 1-cyclopropyl- 6-fluoro- 1,4-dihydro- 4-oxo- 7-(1-piperazinyl)- 3-quinolinecarboxylic acid. Its empirical formula is C17H18FN3O3 and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 250 mg and 500 mg (ciprofloxacin equivalent) strengths. Ciprofloxacin Tablets, USP are white. The inactive ingredients are colloidal silicon dioxide, corn starch, partially pregelatinized maize starch, magnesium stearate, microcrystalline cellulose, sodium starch glycolate (starch from non-GMO potatoes), hypromellose, titanium dioxide and PEG.</Description>
</NDC>
<NDC>
<NDCCode>47335-689-08</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (47335-689-08) </PackageDescription>
<NDC11Code>47335-0689-08</NDC11Code>
<ProductNDC>47335-689</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191204</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091157</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-01-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pregabalin capsules are indicated for.</IndicationAndUsage>
<Description>Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is sparingly soluble in water and slightly soluble in methanol. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35.Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, USP, along with lactose monohydrate and talc as inactive ingredients. The capsule shells contain gelatin, iron oxide black (200 mg and 225 mg), iron oxide red (75 mg, 100 mg, 200 mg, 225 mg and 300 mg) sodium lauryl sulfate and titanium dioxide. The imprinting black ink contains black iron oxide, butyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>47335-689-18</NDCCode>
<PackageDescription>1000 CAPSULE in 1 BOTTLE (47335-689-18) </PackageDescription>
<NDC11Code>47335-0689-18</NDC11Code>
<ProductNDC>47335-689</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191204</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091157</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-01-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pregabalin capsules are indicated for.</IndicationAndUsage>
<Description>Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is sparingly soluble in water and slightly soluble in methanol. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35.Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, USP, along with lactose monohydrate and talc as inactive ingredients. The capsule shells contain gelatin, iron oxide black (200 mg and 225 mg), iron oxide red (75 mg, 100 mg, 200 mg, 225 mg and 300 mg) sodium lauryl sulfate and titanium dioxide. The imprinting black ink contains black iron oxide, butyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>47335-689-83</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (47335-689-83) </PackageDescription>
<NDC11Code>47335-0689-83</NDC11Code>
<ProductNDC>47335-689</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191204</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091157</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-01-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pregabalin capsules are indicated for.</IndicationAndUsage>
<Description>Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is sparingly soluble in water and slightly soluble in methanol. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35.Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, USP, along with lactose monohydrate and talc as inactive ingredients. The capsule shells contain gelatin, iron oxide black (200 mg and 225 mg), iron oxide red (75 mg, 100 mg, 200 mg, 225 mg and 300 mg) sodium lauryl sulfate and titanium dioxide. The imprinting black ink contains black iron oxide, butyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>47335-689-88</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (47335-689-88) </PackageDescription>
<NDC11Code>47335-0689-88</NDC11Code>
<ProductNDC>47335-689</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191204</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091157</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-01-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pregabalin capsules are indicated for.</IndicationAndUsage>
<Description>Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is sparingly soluble in water and slightly soluble in methanol. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35.Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, USP, along with lactose monohydrate and talc as inactive ingredients. The capsule shells contain gelatin, iron oxide black (200 mg and 225 mg), iron oxide red (75 mg, 100 mg, 200 mg, 225 mg and 300 mg) sodium lauryl sulfate and titanium dioxide. The imprinting black ink contains black iron oxide, butyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>49483-689-03</NDCCode>
<PackageDescription>30 CAPSULE, LIQUID FILLED in 1 BOTTLE (49483-689-03) </PackageDescription>
<NDC11Code>49483-0689-03</NDC11Code>
<ProductNDC>49483-689</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paricalcitol</ProprietaryName>
<NonProprietaryName>Paricalcitol</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204948</ApplicationNumber>
<LabelerName>TIME CAP LABORATORIES, INC</LabelerName>
<SubstanceName>PARICALCITOL</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Ergocalciferols [CS], Vitamin D2 Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170103</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1.1 Chronic Kidney Disease Stages 3 and 4. Paricalcitol Capsules are indicated in adults for the prevention and treatment of secondary hyperparathyroidism associated with Chronic Kidney Disease (CKD) Stages 3 and 4. Pediatric use information for patients 10 to 16 years of age is approved for AbbVie Inc.’s Zemplar (Paricalcitol) capsules. However, due to AbbVie Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 1.2 Chronic Kidney Disease Stage 5 Paricalcitol Capsules are indicated in adults for the prevention and treatment of secondary hyperparathyroidism associated with CKD Stage 5 in patients on hemodialysis (HD) or peritoneal dialysis (PD). Pediatric use information for patients 10 to 16 years of age is approved for AbbVie Inc.’s Zemplar (Paricalcitol) capsules. However, due to AbbVie Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.</IndicationAndUsage>
<Description>Paricalcitol, USP, the active ingredient in Paricalcitol Capsules, is a synthetically manufactured, metabolically active vitamin D analog of calcitriol with modifications to the side chain (D 2) and the A (19-nor) ring. Paricalcitol is available as soft gelatin capsules for oral administration containing 1 microgram, 2 micrograms, and 4 micrograms of paricalcitol. Each capsule also contains medium chain triglycerides, alcohol, and butylated hydroxytoluene. ..The capsule shell is composed of gelatin, glycerin, Noncrystallizing Sorbitol solution, titanium dioxide, iron oxide red (2 microgram capsules only), iron oxide yellow (2 microgram and 4 microgram capsules), iron oxide black (1 microgram capsules only) and water. The soft gelatin capsules are printed with black ink Opacode Black (S-1-17823) containing Isopropyl alcohol, Black iron oxide, N-Butyl alcohol, Propylene glycol, Ammonium hydroxide and Shellac. Paricalcitol is a white, crystalline powder with the empirical formula of C 27H 44O 3, which corresponds to a molecular weight of 416.64. Paricalcitol is chemically designated as 19-nor-1α,3β,25-trihydroxy-9,10-secoergosta-5(Z),7(E),22(E)- triene and has the following structural formula:.</Description>
</NDC>
<NDC>
<NDCCode>49884-689-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (49884-689-01) </PackageDescription>
<NDC11Code>49884-0689-01</NDC11Code>
<ProductNDC>49884-689</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoclopramide</ProprietaryName>
<NonProprietaryName>Metoclopramide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19851017</StartMarketingDate>
<EndMarketingDate>20231031</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070581</ApplicationNumber>
<LabelerName>Par Pharmaceutical, Inc.</LabelerName>
<SubstanceName>METOCLOPRAMIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine D2 Antagonists [MoA], Dopamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150803</StartMarketingDatePackage>
<EndMarketingDatePackage>20231031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49884-689-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (49884-689-05) </PackageDescription>
<NDC11Code>49884-0689-05</NDC11Code>
<ProductNDC>49884-689</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoclopramide</ProprietaryName>
<NonProprietaryName>Metoclopramide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19851017</StartMarketingDate>
<EndMarketingDate>20231031</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070581</ApplicationNumber>
<LabelerName>Par Pharmaceutical, Inc.</LabelerName>
<SubstanceName>METOCLOPRAMIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine D2 Antagonists [MoA], Dopamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150803</StartMarketingDatePackage>
<EndMarketingDatePackage>20231031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49967-689-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (49967-689-01) > 50 mL in 1 TUBE</PackageDescription>
<NDC11Code>49967-0689-01</NDC11Code>
<ProductNDC>49967-689</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Loreal Paris Revitalift</ProprietaryName>
<ProprietaryNameSuffix>Clinical Repair 10 Spf 20</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone Homosalate Octisalate Octocrylene</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110801</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>L'Oreal USA Products Inc</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>1.5; 5; 2.5; 3.5</StrengthNumber>
<StrengthUnit>mL/50mL; mL/50mL; mL/50mL; mL/50mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-14</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>50268-689-15</NDCCode>
<PackageDescription>50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-689-15) > 1 TABLET in 1 BLISTER PACK (50268-689-11)</PackageDescription>
<NDC11Code>50268-0689-15</NDC11Code>
<ProductNDC>50268-689</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quinapril</ProprietaryName>
<NonProprietaryName>Quinapril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140805</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078457</ApplicationNumber>
<LabelerName>AvPAK</LabelerName>
<SubstanceName>QUINAPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-03-11</LastUpdate>
</NDC>
<NDC>
<NDCCode>53031-011-01</NDCCode>
<PackageDescription>985 mL in 1 BOTTLE (53031-011-01) </PackageDescription>
<NDC11Code>53031-0011-01</NDC11Code>
<ProductNDC>53031-011</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Instant Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Instant Hand Sanitizer</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Dongyang Medical & Hygienic Articles Co., Ltd.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>689.5</StrengthNumber>
<StrengthUnit>mL/985mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-10-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>