{
"NDC": [
{
"NDCCode": "67046-1136-3",
"PackageDescription": "30 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67046-1136-3) ",
"NDC11Code": "67046-1136-03",
"ProductNDC": "67046-1136",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Divalproex Sodium",
"NonProprietaryName": "Divalproex Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20241111",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079163",
"LabelerName": "Coupler LLC",
"SubstanceName": "DIVALPROEX SODIUM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241111",
"SamplePackage": "N",
"IndicationAndUsage": "Divalproex sodium is an anti-epileptic drug indicated for: 1 Treatment of manic episodes associated with bipolar disorder ( 1.1) , 2 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures ( 1.2) , 3 Prophylaxis of migraine headaches ( 1.3) .",
"Description": "Divalproex sodium, USP is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium, USP has the following structure. Divalproex sodium, USP occurs as a white powder with a characteristic odor. Divalproex sodium delayed-release tablets, USP are for oral administration. Divalproex sodium delayed-release tablets, USP are supplied in three dosage strengths containing divalproex sodium, USP equivalent to 125 mg, 250 mg, or 500 mg of valproic acid. Inactive Ingredients. Divalproex sodium delayed-release tablets, USP: Microcrystalline cellulose, opadry II white 33G28707, povidone, pregelatinized starch (contains corn starch), silicon dioxide, simethicone, talc and vanillin. Opadry II white 33G28707 consists of hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide and triacetin. Imprinting ink contains ethanol, shellac glaze, iron oxide black, isopropyl alcohol, N-butyl alcohol and propylene glycol. In addition, individual tablets contain. 125 mg tablets: Acryl EZE Orange which consists of FD & C Yellow No. 6, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate & yellow iron oxide. 250 mg tablets: Acryl EZE Pink which consists of D & C Red No. 30, FD & C Blue No. 2, iron oxide red, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. 500 mg tablets: Acryl EZE Pink which consists of FD & C Red No. 40, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate."
},
{
"NDCCode": "36987-1136-3",
"PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (36987-1136-3)",
"NDC11Code": "36987-1136-03",
"ProductNDC": "36987-1136",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Egg Yolk",
"NonProprietaryName": "Egg Yolk",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "EGG YOLK",
"StrengthNumber": ".1",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Egg Proteins, Dietary [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "37662-1136-3",
"PackageDescription": "3000 PELLET in 1 BOTTLE, GLASS (37662-1136-3) ",
"NDC11Code": "37662-1136-03",
"ProductNDC": "37662-1136",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Manganum Muriaticum",
"NonProprietaryName": "Manganum Muriaticum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220801",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "MANGANESE CHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "[hp_C]/1",
"Pharm_Classes": "Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC]",
"Status": "Active",
"LastUpdate": "2022-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220801",
"SamplePackage": "N"
},
{
"NDCCode": "64942-1136-3",
"PackageDescription": "14 g in 1 CONTAINER (64942-1136-3)",
"NDC11Code": "64942-1136-03",
"ProductNDC": "64942-1136",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Degree",
"ProprietaryNameSuffix": "Cotton Fresh Antiperspirant And Deodorant",
"NonProprietaryName": "Aluminum Zirconium Tetrachlorohydrex Gly",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20101215",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part350",
"LabelerName": "Conopco Inc. d/b/a Unilever",
"SubstanceName": "ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY",
"StrengthNumber": "18.2",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "70677-1136-3",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (70677-1136-3) ",
"NDC11Code": "70677-1136-03",
"ProductNDC": "70677-1136",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Foster And Thrive Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20231020",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072096",
"LabelerName": "Strategic Sourcing Services LLC",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231020",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to:headachemuscular achesminor pain of arthritistoothachebackache the common coldmenstrual cramps. temporarily reduces fever."
},
{
"NDCCode": "71335-1136-3",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (71335-1136-3) ",
"NDC11Code": "71335-1136-03",
"ProductNDC": "71335-1136",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Losartan Potassium",
"NonProprietaryName": "Losartan Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20121206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091541",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "LOSARTAN POTASSIUM",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190304",
"SamplePackage": "N",
"IndicationAndUsage": "Losartan potassium tablet is an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. ( 1.2) , 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. ( 1.3) .",
"Description": "Losartan potassium tablets USP is an angiotensin II receptor blocker acting on the AT 1 receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[ p-( o-1 Htetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its molecular formula is C 22H 22ClKN 6O, and its structural formula is:. Losartan potassium USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: Microcrystalline cellulose, lactose monohydrate, pregelatinized starch, magnesium stearate, Opadry white (hydroxypropyl cellulose, hypromellose and titanium dioxide). Losartan potassium 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively."
},
{
"NDCCode": "0093-1136-56",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0093-1136-56) ",
"NDC11Code": "00093-1136-56",
"ProductNDC": "0093-1136",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acitretin",
"NonProprietaryName": "Acitretin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20130719",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091455",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "ACITRETIN",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2025-09-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130719",
"SamplePackage": "N",
"IndicationAndUsage": "Acitretin Capsules are indicated for the treatment of severe psoriasis in adults. Because of significant adverse effects associated with its use, Acitretin Capsules should be prescribed only by those knowledgeable in the systemic use of retinoids. In females of reproductive potential, Acitretin Capsules should be reserved for non-pregnant patients who are unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments (see boxed CONTRAINDICATIONS AND WARNINGS — Acitretin Capsules can cause severe birth defects). Most patients experience relapse of psoriasis after discontinuing therapy. Subsequent courses, when clinically indicated, have produced efficacy results similar to the initial course of therapy.",
"Description": "Acitretin, USP (micronized), a retinoid, is available in 10 mg, 17.5 mg, and 25 mg gelatin capsules for oral administration. Chemically, acitretin is all-trans-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethyl-2,4,6,8-nonatetraenoic acid. It is a metabolite of etretinate and is related to both retinoic acid and retinol (vitamin A). It is a yellow to greenish-yellow crystalline powder. The structural formula is. C21H26O3 M.W. 326.43. Each capsule contains acitretin, USP (micronized) 10 mg, 17.5 mg, and 25 mg. Inactive ingredients are crospovidone, microcrystalline cellulose, poloxamer, povidone, sodium ascorbate and sodium lauryl sulfate. The 10 mg, 17.5, and 25 mg gelatin capsule shells contain gelatin and titanium dioxide. The 10 mg and 25 mg capsule shells also contain D&C yellow no. 10, FD&C blue no. 1, and FD&C red no. 40. The 17.5 mg capsule shells also contain red iron oxide and yellow iron oxide. The 25 mg gelatin capsule shells also contain FD&C yellow no. 6. The edible imprinting ink contains black iron oxide, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, propylene glycol and shellac glaze. Meets USP Dissolution Test 2."
},
{
"NDCCode": "17856-1136-1",
"PackageDescription": "15 g in 1 POUCH (17856-1136-1) ",
"NDC11Code": "17856-1136-01",
"ProductNDC": "17856-1136",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Polystyrene Sulfonate",
"NonProprietaryName": "Sodium Polystyrene Sulfonate",
"DosageFormName": "POWDER",
"RouteName": "ORAL; RECTAL",
"StartMarketingDate": "20120725",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040905",
"LabelerName": "ATLANTIC BIOLOGICALS CORP",
"SubstanceName": "SODIUM POLYSTYRENE SULFONATE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20160923",
"SamplePackage": "N",
"IndicationAndUsage": "Sodium Polystyrene Sulfonate, USP is indicated for the treatment of hyperkalemia.",
"Description": "Sodium Polystyrene Sulfonate, USP, is a benzene, diethenyl-polymer, with ethenylbenzene, sulfonated, sodium salt and has the following structural formula. The drug is a cream to light brown finely ground, powdered form of sodium polystyrene sulfonate, a cation-exchange resin prepared in the sodium phase with an in vitro exchange capacity of approximately 3.1 mEq (in vivo approximately 1 mEq) of potassium per gram. The sodium content is approximately 100 mg (4.1 mEq) per gram of the drug. It can be administered orally or in an enema."
},
{
"NDCCode": "33992-1136-1",
"PackageDescription": "42.5 g in 1 TUBE (33992-1136-1) ",
"NDC11Code": "33992-1136-01",
"ProductNDC": "33992-1136",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Assured",
"ProprietaryNameSuffix": "Muscle Rub",
"NonProprietaryName": "Menthol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120515",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Greenbrier International, Inc.",
"SubstanceName": "MENTHOL, UNSPECIFIED FORM",
"StrengthNumber": "2.5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20120515",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves the minor aches and pains in muscles and joints associated with: 1 simple backache, 2 arthritis, 3 strains, 4 bruises, 5 sprains."
},
{
"NDCCode": "50090-1136-0",
"PackageDescription": "5 mL in 1 BOTTLE (50090-1136-0) ",
"NDC11Code": "50090-1136-00",
"ProductNDC": "50090-1136",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tobramycin And Dexamethasone",
"NonProprietaryName": "Tobramycin And Dexamethasone",
"DosageFormName": "SUSPENSION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20090102",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA050592",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "TOBRAMYCIN; DEXAMETHASONE",
"StrengthNumber": "3; 1",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141128",
"SamplePackage": "N",
"IndicationAndUsage": "Tobramycin and dexamethasone ophthalmic suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. The particular anti-infective drug in this product is active against the following common bacterial eye pathogens. Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains. Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae. Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae and H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria species.",
"Description": "Tobramycin and dexamethasone ophthalmic suspension is a sterile, multiple dose antibiotic and steroid combination for topical ophthalmic use. The chemical structures for tobramycin and dexamethasone are presented below. Tobramycin Empirical Formula: C18H37N5O9. Chemical Name: O-3-Amino-3-deoxy-α- D-glucopyranosyl-(1→4)-O-[2,6-diamino-2,3,6-trideoxy-α-D-ribo-hexopyranosyl- (1→6)]-2-deoxy-L-streptamine. Molecular Weight: 467.52. Dexamethasone Empirical Formula: C22H29FO5. Chemical Name: 9-Fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione. Molecular Weight: 392.47. Each mL of tobramycin and dexamethasone ophthalmic suspension contains: Actives: tobramycin 0.3% (3 mg) and dexamethasone 0.1% (1 mg). Preservative: benzalkonium chloride 0.01%. Inactives: edetate disodium, hydroxyethyl cellulose, purified water, sodium chloride, sodium sulfate, sulfuric acid and/or sodium hydroxide (to adjust pH), and tyloxapol."
},
{
"NDCCode": "67046-0003-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BLISTER PACK (67046-0003-3) ",
"NDC11Code": "67046-0003-03",
"ProductNDC": "67046-0003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mirtazapine",
"NonProprietaryName": "Mirtazapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20241218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076921",
"LabelerName": "Coupler LLC",
"SubstanceName": "MIRTAZAPINE",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241218",
"SamplePackage": "N",
"IndicationAndUsage": "Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)]."
},
{
"NDCCode": "67046-0007-3",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (67046-0007-3) ",
"NDC11Code": "67046-0007-03",
"ProductNDC": "67046-0007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alprazolam",
"NonProprietaryName": "Alprazolam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260505",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203346",
"LabelerName": "Coupler LLC",
"SubstanceName": "ALPRAZOLAM",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2026-05-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260505",
"SamplePackage": "N",
"IndicationAndUsage": "Alprazolam tablets are indicated for the: : 1 acute treatment of generalized anxiety disorder (GAD) in adults., 2 treatment of panic disorder (PD), with or without agoraphobia in adults.",
"Description": "Alprazolam tablets, USP contain alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The structural formula is. Alprazolam USP is a white to off-white, crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. Each alprazolam tablet USP, for oral administration, contains 0.25 mg, 0.5 mg, 1 mg, or 2 mg of alprazolam USP. Inactive ingredients: colloidal silicon dioxide, corn starch, docusate sodium 85% with sodium benzoate 15%, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. In addition, the 0.5 mg tablet contains FD&C Yellow # 6 aluminum lake and the 1 mg tablet contains FD&C Blue No. 2 lake."
},
{
"NDCCode": "67046-0015-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BLISTER PACK (67046-0015-3) ",
"NDC11Code": "67046-0015-03",
"ProductNDC": "67046-0015",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260424",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065256",
"LabelerName": "Coupler LLC",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "875",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260424",
"SamplePackage": "N",
"IndicationAndUsage": "Adults and Pediatric Patients: 1 Upper Respiratory Tract Infections of the Ear, Nose, and Throat:Amoxicillin tablets are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcusspecies. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcusspp., or Haemophilus influenzae. .",
"Description": "Amoxicillin tablets, USP are a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl) acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin molecular formula is C 16H 19N 3O 5S 3H 2O, and the molecular weight is 419.45. Each film coated tablet contains 500 mg or 875 mg amoxicillin USP as the trihydrate. The 500 mg pink colored, capsule shaped, film coated tablets debossed with “A” on one side and “66” on the other side. The 875 mg pink colored, capsule shaped, film coated tablets debossed with “A” on one side and with a score line in between “6” and “7” on the other side. Inactive ingredients: Colloidal silicon dioxide, crospovidone, D&C Red No. 30 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide."
},
{
"NDCCode": "67046-0038-3",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (67046-0038-3) ",
"NDC11Code": "67046-0038-03",
"ProductNDC": "67046-0038",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine Fumarate",
"NonProprietaryName": "Quetiapine Fumarate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20241218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201504",
"LabelerName": "Coupler LLC",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241218",
"SamplePackage": "N",
"IndicationAndUsage": "Quetiapine is an atypical antipsychotic indicated for the treatment of. · Schizophrenia ( 1.1). · Bipolar I disorder manic episodes ( 1.2). · Bipolar disorder, depressive episodes ( 1.2).",
"Description": "Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [ b,f] [1,4]thiazepin-11-yl-1-piperazinyl) ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C 42H 50N 6O 4S 2C 4H 4O 4and it has a molecular weight of 883.11 (fumarate salt). The structural formula is:. Quetiapine fumarate USP is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablets, USP is supplied for oral administration as 25 mg (round peach), 50 mg (round, white), 100 mg (round yellow), 150 mg (round, off white to light yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are povidone, dibasic dicalcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, hypromellose, polyethylene glycol and titanium dioxide. The 25 mg tablets contain red iron oxide and yellow iron oxide and the 100 mg, 150 mg and 400 mg tablets contain only yellow iron oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate USP equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate USP equivalent to 100 mg quetiapine. Each 150 mg tablet contains 172.70 mg of quetiapine fumarate USP equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.27 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.40 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.54 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine."
},
{
"NDCCode": "67046-0040-3",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (67046-0040-3) ",
"NDC11Code": "67046-0040-03",
"ProductNDC": "67046-0040",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benztropine Mesylate",
"NonProprietaryName": "Benztropine Mesylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260526",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040715",
"LabelerName": "Coupler LLC",
"SubstanceName": "BENZTROPINE MESYLATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Antihistamine [EPC], Cholinergic Antagonists [MoA], Histamine Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260526",
"SamplePackage": "N",
"IndicationAndUsage": "For use as an adjunct in the therapy of all forms of parkinsonism. Useful also in the control of extrapyramidal disorders (except tardive dyskinesia – see PRECAUTIONS) due to neuroleptic drugs (e.g., phenothiazines).",
"Description": "Benztropine mesylate is a synthetic compound containing structural features found in atropine and diphenhydramine. It is a crystalline white powder, very soluble in water, designated as 3α-(Diphenylmethoxy)-1αH, 5αH-tropane methanesulfonate, with the following structural formula. Each tablet, for oral administration, contains 0.5 mg, 1 mg or 2 mg of benztropine mesylate. Each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate, lactose monohydrate, magnesium stearate and microcrystalline cellulose."
},
{
"NDCCode": "67046-0041-3",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (67046-0041-3) ",
"NDC11Code": "67046-0041-03",
"ProductNDC": "67046-0041",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benztropine Mesylate",
"NonProprietaryName": "Benztropine Mesylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260424",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040715",
"LabelerName": "Coupler LLC",
"SubstanceName": "BENZTROPINE MESYLATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Antihistamine [EPC], Cholinergic Antagonists [MoA], Histamine Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260424",
"SamplePackage": "N",
"IndicationAndUsage": "For use as an adjunct in the therapy of all forms of parkinsonism. Useful also in the control of extrapyramidal disorders (except tardive dyskinesia – see PRECAUTIONS) due to neuroleptic drugs (e.g., phenothiazines).",
"Description": "Benztropine mesylate is a synthetic compound containing structural features found in atropine and diphenhydramine. It is a crystalline white powder, very soluble in water, designated as 3α-(Diphenylmethoxy)-1αH, 5αH-tropane methanesulfonate, with the following structural formula. Each tablet, for oral administration, contains 0.5 mg, 1 mg or 2 mg of benztropine mesylate. Each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate, lactose monohydrate, magnesium stearate and microcrystalline cellulose."
},
{
"NDCCode": "67046-0053-3",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (67046-0053-3) ",
"NDC11Code": "67046-0053-03",
"ProductNDC": "67046-0053",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Haloperidol",
"NonProprietaryName": "Haloperidol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250702",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071173",
"LabelerName": "Coupler LLC",
"SubstanceName": "HALOPERIDOL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Typical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250702",
"SamplePackage": "N",
"IndicationAndUsage": "Haloperidol tablets, USP are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets, USP are indicated for the control of tics and vocal utterances of Tourette’s Disorder in children and adults. Haloperidol tablets, USP are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol tablets, USP are also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidol tablets, USP should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics.",
"Description": "Haloperidol is the first of the butyrophenone series of major tranquilizers. The chemical designation is 4-[4-(p-chloro-phenyl)-4-hydroxypiperidino]-4’—fluorobutyrophenone and it has the following structural formula. C21H23ClFNO2375.87. Haloperidol is supplied as tablets for oral administration containing 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg or 20 mg of haloperidol, USP and contains the following inactive ingredients: magnesium stearate, microcrystalline cellulose, pregelatinized starch. In addition, the 1 mg, 5 mg and 10 mg tablets contain D&C Yellow No. 10 Aluminum Lake. The 5 mg and 10 mg tablets contain FD&C Blue No. 1 Aluminum Lake, 20 mg tablets contain FD&C Red No. 40 Aluminum Lake."
},
{
"NDCCode": "67046-0057-3",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (67046-0057-3) ",
"NDC11Code": "67046-0057-03",
"ProductNDC": "67046-0057",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meloxicam",
"NonProprietaryName": "Meloxicam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260427",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077921",
"LabelerName": "Coupler LLC",
"SubstanceName": "MELOXICAM",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260427",
"SamplePackage": "N",
"IndicationAndUsage": "Meloxicam Tablets are non-steroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) ( 1.1) , 2 Rheumatoid Arthritis (RA) ( 1.2) , 3 Juvenile Rheumatoid Arthritis (JRA) in patients who weigh ≥ 60 kg ( 1.3) .",
"Description": "Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID). Each yellow meloxicam tablet contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl- N-(5-methyl-2-thiazolyl)-2 H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14H 13N 3O 4S 2and it has the following structural formula. Meloxicam, USP is a pale yellow powder, practically insoluble in water, slightly soluble in acetone, soluble in dimethylformamide, very slightly soluble in ethanol (96 %) and in methanol. Meloxicam has an apparent partition coefficient (log P) app= 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Each meloxicam tablet, USP intended for oral administration contains 7.5 mg or 15 mg of meloxicam. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium citrate dihydrate."
},
{
"NDCCode": "67046-0059-3",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (67046-0059-3) ",
"NDC11Code": "67046-0059-03",
"ProductNDC": "67046-0059",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenobarbital",
"NonProprietaryName": "Phenobarbital",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260622",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Coupler LLC",
"SubstanceName": "PHENOBARBITAL",
"StrengthNumber": "32.4",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260622",
"SamplePackage": "N",
"IndicationAndUsage": "1. Sedative 2. Anticonvulsant - For the treatment of generalized and partial seizures.",
"Description": "The barbiturates are nonselective central nervous system (CNS) depressants that are primarily used as sedative-hypnotics. In subhypnotic doses, they are also used as anticonvulsants. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act. Phenobarbital is a barbituric acid derivative and occurs as white, odorless, small crystals or crystalline powder that is very slightly soluble in water; soluble in alcohol, in ether, and in solutions of fixed alkali hydroxides and carbonates; sparingly soluble in chloroform. Phenobarbital is 5-ethyl-5- phenylbarbituric acid. Phenobarbital is a substituted pyrimidine derivative in which the basic structure is barbituric acid, a substance that has no CNS activity. CNS activity is obtained by substituting alkyl, alkenyl, or aryl groups on the pyrimidine ring. It has the following structural formula:. C 12H 12N 2O 3 M.W. = 232.24 Each phenobarbital tablet contains 16.2 mg, 32.4 mg, 64.8 mg, or 97.2 mg of phenobarbital, USP. Inactive ingredients include:colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and magnesium stearate."
},
{
"NDCCode": "67046-0060-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BLISTER PACK (67046-0060-3) ",
"NDC11Code": "67046-0060-03",
"ProductNDC": "67046-0060",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naltrexone Hydrochloride",
"NonProprietaryName": "Naltrexone Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260527",
"EndMarketingDate": "20271130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075274",
"LabelerName": "Coupler LLC",
"SubstanceName": "NALTREXONE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Opioid Antagonist [EPC], Opioid Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20260527",
"EndMarketingDatePackage": "20271130",
"SamplePackage": "N",
"IndicationAndUsage": "Naltrexone Hydrochloride Tablets USP are indicated in the treatment of alcohol dependence and for the blockade of the effects of exogenously administered opioids. Naltrexone Hydrochloride Tablets USP have not been shown to provide any therapeutic benefit except as part of an appropriate plan of management for the addictions.",
"Description": "Naltrexone hydrochloride, an opioid antagonist, are a synthetic congener of oxymorphone with no opioid agonist properties. Naltrexone differs in structure from oxymorphone in that the methyl group on the nitrogen atom is replaced by a cyclopropylmethyl group. Naltrexone hydrochloride is also related to the potent opioid antagonist, naloxone, or n-allylnoroxymorphone. The chemical name for naltrexone hydrochloride is Morphinan-6-one, 17-(cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxy-, hydrochloride, (5a)-. The structural formula is as follows. Naltrexone hydrochloride is a white, crystalline compound. The hydrochloride salt is soluble in water to the extent of about 100 mg/mL. Naltrexone Hydrochloride Tablets USP are available in scored film-coated tablets containing 50 mg of naltrexone hydrochloride. Naltrexone Hydrochloride Tablets USP also contain: carnauba wax powder, colloidal silicon dioxide, croscarmellose sodium, hypromellose, hydroxypropyl cellulose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide and yellow iron oxide."
},
{
"NDCCode": "67046-0068-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BLISTER PACK (67046-0068-3) ",
"NDC11Code": "67046-0068-03",
"ProductNDC": "67046-0068",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mirtazapine",
"NonProprietaryName": "Mirtazapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260427",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076921",
"LabelerName": "Coupler LLC",
"SubstanceName": "MIRTAZAPINE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-04-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260427",
"SamplePackage": "N",
"IndicationAndUsage": "Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].",
"Description": "Mirtazapine tablets, USP contain mirtazapine USP. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro-2-methylpyrazino [2,1-a] pyrido [2,3-c][2] benzazepine and has the molecular formula of C 17H 19N 3. Its molecular weight is 265.35. The structural formula is the following and it is the racemic mixture:. Mirtazapine is a white to creamy white crystalline powder which is practically insoluble in water. Mirtazapine tablets, USP are available for oral administration as scored film-coated tablets containing 15 or 30 mg of mirtazapine USP, and unscored film-coated tablets containing 7.5 or 45 mg of mirtazapine USP. Each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, and titanium dioxide. In addition, the 15 mg contains iron oxide yellow and 30 mg contains iron oxide red, iron oxide black, and iron oxide yellow."
},
{
"NDCCode": "67046-0072-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BLISTER PACK (67046-0072-3) ",
"NDC11Code": "67046-0072-03",
"ProductNDC": "67046-0072",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260619",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202862",
"LabelerName": "Coupler LLC",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260619",
"SamplePackage": "N",
"IndicationAndUsage": "Olanzapine is an atypical antipsychotic indicated. As oral formulation for the:. · Treatment of schizophrenia. ( 1.1). · Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. ( 14.1). · Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia ( 14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.1). · Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. ( 1.2). · Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. ( 14.2). · Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder ( 14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.2). · Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. ( 1.3). · Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. ( 1.2). · Efficacy was established in two 6-week clinical trials in adults ( 14.2). Maintenance efficacy has not been systematically evaluated. As Olanzapine and Fluoxetine in Combination for the: Treatment of depressive episodes associated with bipolar I disorder. ( 1.5) Efficacy was established with Symbyax (olanzapine and fluoxetine in combination); refer to the product label for Symbyax. Treatment of treatment resistant depression. ( 1.6) Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.",
"Description": "Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose. The color coating contains Titanium Dioxide (all strengths), FD&C Blue No. 2 indigo carmine Aluminum Lake (15 mg), or Synthetic Red Iron Oxide (20 mg)."
},
{
"NDCCode": "67046-0113-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BLISTER PACK (67046-0113-3) ",
"NDC11Code": "67046-0113-03",
"ProductNDC": "67046-0113",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Citalopram",
"NonProprietaryName": "Citalopram",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260610",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078216",
"LabelerName": "Coupler LLC",
"SubstanceName": "CITALOPRAM HYDROBROMIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260610",
"SamplePackage": "N",
"IndicationAndUsage": "Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies ( 14)] .",
"Description": "Citalopram tablets, USP contain citalopram, a selective serotonin reuptake inhibitor (SSRI). Citalopram hydrobromide is a racemic bicyclic phthalane structure and is designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3dihydroisobenzofuran-5-carbonitrile hydrobromide with the following structural formula. The molecular formula is C 20H 22BrFN 2O and its molecular weight is 405.35. Citalopram hydrobromide, USP occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol. Citalopram, USP 10 mg tablets are film-coated, round shaped tablets containing citalopram hydrobromide in strengths equivalent to 10 mg citalopram base. Citalopram hydrobromide, USP 20 mg and 40 mg tablets are film-coated, oval shaped, scored tablets containing citalopram hydrobromide, in strengths equivalent to 20 mg or 40 mg citalopram base. The tablets also contain the following inactive ingredients: copovidone, corn starch, croscarmellose sodium, ferric oxide red, ferric oxide yellow, glycerin, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide."
},
{
"NDCCode": "67046-0127-3",
"PackageDescription": "30 CAPSULE in 1 BLISTER PACK (67046-0127-3) ",
"NDC11Code": "67046-0127-03",
"ProductNDC": "67046-0127",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260504",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064076",
"LabelerName": "Coupler LLC",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260504",
"SamplePackage": "N",
"IndicationAndUsage": "Adults and Pediatric Patients: 1 Upper Respiratory Tract Infections of the Ear, Nose, and Throat.",
"Description": "Amoxicillin is a semisynthetic antibacterial, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[(R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4- thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin molecular formula is C 16H 19N 3O 5S 3H 2O, and the molecular weight is 419.45. Amoxicillin Capsules, USP. Each amoxicillin capsule, with yellow opaque cap and body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The 250 mg capsule is imprinted AMOX 250 on one side and GG 848 on the other side; the 500 mg capsule is imprinted AMOX 500 on one side and GG 849 on the other side. Inactive ingredients: Capsule shells - yellow ferric oxide, titanium dioxide, gelatin, black ferric oxide, shellac, propylene glycol, potassium hydroxide and ammonium hydroxide; Capsule contents - cellulose microcrystalline and magnesium stearate. Meets USP Dissolution Test 2. Amoxicillin Tablets, USP. Each film coated tablet contains 500 mg or 875 mg of amoxicillin as the trihydrate. The tablets are oval-shaped and white to yellowish. The 500 mg tablet is unscored, embossed GG-961 on one side and 500 on the other side. The 875 mg tablet is scored and embossed GG-962 on one side and 875 on the other side. In addition each amoxicillin tablet contains these inactive ingredients in each 500 mg or 875 mg tablet: colloidal silicon dioxide, crospovidone, ethylcellulose aqueous dispersion, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, talc, triethyl citrate, and titanium dioxide. Amoxicillin for Oral Suspension, USP. Each 5 mL of reconstituted suspension contains 125 mg, 200 mg, 250 mg or 400 mg amoxicillin as the trihydrate. Each 5 mL of the 125 mg, 200 mg, 250 mg, and 400 mg reconstituted suspension contains 0.30 mEq (6.95 mg) of sodium. Amoxicillin trihydrate for oral suspension 125 mg/5 mL, 200 mg/5 mL, 250 mg/5 mL and 400 mg/5 mL are fruity flavored pink suspensions. Inactive ingredients: anhydrous citric acid, colloidal silicon dioxide, flavorings: raspberry, strawberry, refrachessement, FD&C Red 40, sodium benzoate, sodium citrate, sucrose, and xantham gum."
},
{
"NDCCode": "67046-0135-3",
"PackageDescription": "30 CAPSULE in 1 BLISTER PACK (67046-0135-3) ",
"NDC11Code": "67046-0135-03",
"ProductNDC": "67046-0135",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260526",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062396",
"LabelerName": "Coupler LLC",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2026-05-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260526",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate capsules and other antibacterial drugs, doxycycline hyclate capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Doxycycline Hyclate Capsules, USP is an antibacterial drug synthetically derived from oxytetracycline. The structural formula of doxycycline hyclate is. with a molecular formula of (C 22H 24N 2O 8HCL) 2C 2H 6OH 2O and a molecular weight of 1025.88. The chemical designation for doxycycline is 2-Naphthacenecarboxamide, 4-(dimethylamino)-1, 4, 4a, 5, 5a, 6, -11, 12a-octahydro-3,5,10, 12, 12a-pentahydroxy-6-methyl-1, 11-dioxo-monohydrochloride, compound with ethanol(2:1), monohydrate, [4s-(4α, 4aα, 5α, 5aα, 6α, 12aα)]. Doxycycline is a yellow crystalline powder. Doxycycline hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each capsule for oral administration contains doxycycline hyclate equivalent to 50 mg or 100 mg of doxycycline (anhydrous). Inactive ingredients: lactose monohydrate, microcrystalline cellulose, magnesium stearate. The 50 mg and 100 mg capsule shells contain: gelatin, FD&C Blue #1 and titanium dioxide. The printing ink may contain: Shellac Glaze, Iron Oxide Black, N-Butyl Alcohol, Propylene Glycol, SD-45 Alcohol, FD&C Blue #2, FD&C Red #40, FD&C Blue #1, D&C Yellow #10."
},
{
"NDCCode": "67046-0154-3",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (67046-0154-3) ",
"NDC11Code": "67046-0154-03",
"ProductNDC": "67046-0154",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alprazolam",
"NonProprietaryName": "Alprazolam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260429",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203346",
"LabelerName": "Coupler LLC",
"SubstanceName": "ALPRAZOLAM",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260429",
"SamplePackage": "N",
"IndicationAndUsage": "Alprazolam tablets are indicated for the: : 1 acute treatment of generalized anxiety disorder (GAD) in adults., 2 treatment of panic disorder (PD), with or without agoraphobia in adults.",
"Description": "Alprazolam tablets, USP contain alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The structural formula is. Alprazolam USP is a white to off-white, crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. Each alprazolam tablet USP, for oral administration, contains 0.25 mg, 0.5 mg, 1 mg, or 2 mg of alprazolam USP. Inactive ingredients: colloidal silicon dioxide, corn starch, docusate sodium 85% with sodium benzoate 15%, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. In addition, the 0.5 mg tablet contains FD&C Yellow # 6 aluminum lake and the 1 mg tablet contains FD&C Blue No. 2 lake."
},
{
"NDCCode": "67046-0155-3",
"PackageDescription": "30 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67046-0155-3) ",
"NDC11Code": "67046-0155-03",
"ProductNDC": "67046-0155",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole Sodium",
"NonProprietaryName": "Pantoprazole",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20241106",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202882",
"LabelerName": "Coupler LLC",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241106",
"SamplePackage": "N",
"IndicationAndUsage": "Pantoprazole sodium delayed-release tablets are indicated for."
},
{
"NDCCode": "67046-0179-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BLISTER PACK (67046-0179-3) ",
"NDC11Code": "67046-0179-03",
"ProductNDC": "67046-0179",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxcarbazepine",
"NonProprietaryName": "Oxcarbazepine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260428",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077802",
"LabelerName": "Coupler LLC",
"SubstanceName": "OXCARBAZEPINE",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260428",
"SamplePackage": "N",
"IndicationAndUsage": "Oxcarbazepine tablets are indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures.",
"Description": "Oxcarbazepine Tablets USP are an antiepileptic drug available as 150 mg, 300 mg, and 600 mg film-coated tablets for oral administration. Oxcarbazepine, USP is 10,11-Dihydro-10-oxo- 5H-dibenz[b, f]azepine-5-carboxamide, and its structural formula is:. Oxcarbazepine, USP is a light orange to creamish white or off-white powder. It is soluble in acetic acid, sparingly soluble in chloroform, practically insoluble in water. Its molecular weight is 252.27 g/mol. Oxcarbazepine film-coated tablets contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, ferric oxide (yellow), hypromellose, magnesium stearate, meglumine, microcrystalline cellulose, polyethylene glycol, and titanium dioxide."
},
{
"NDCCode": "67046-0186-3",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (67046-0186-3) ",
"NDC11Code": "67046-0186-03",
"ProductNDC": "67046-0186",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoclopramide",
"NonProprietaryName": "Metoclopramide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260602",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072801",
"LabelerName": "Coupler LLC",
"SubstanceName": "METOCLOPRAMIDE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine D2 Antagonists [MoA], Dopamine-2 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260602",
"SamplePackage": "N",
"IndicationAndUsage": "Metoclopramide tablets are indicated for the: 1 Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy., 2 Relief of symptoms in adults with acute and recurrent diabetic gastroparesis.",
"Description": "Metoclopramide hydrochloride, USP, the active ingredient of metoclopramide tablets, USP is a dopamine-2 receptor antagonist. Metoclopramide hydrochloride (metoclopramide monohydrochloride monohydrate) is a white or practically white, crystalline, odorless or practically odorless powder. It is very soluble in water, freely soluble in alcohol, sparingly soluble in chloroform and practically insoluble in ether. Chemically, it is 4-amino-5-chloro- N-[2-(diethylamino)ethyl]-2-methoxy benzamide monohydrochloride monohydrate. Its structural formula is as follows:. C 14H 22ClN 3O 2HClH 2O M.W. 354.3. Metoclopramide tablets, USP are for oral administration. Metoclopramide tablets, USP are available in 5 mg and 10 mg tablets. : 1 Each metoclopramide tablet USP, 5 mg contains 5 mg metoclopramide (equivalent to 5.91 mg of metoclopramide hydrochloride, USP)., 2 Each metoclopramide tablet USP, 10 mg contains 10 mg metoclopramide (equivalent to 11.82 mg of metoclopramide hydrochloride, USP)."
},
{
"NDCCode": "67046-0211-3",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (67046-0211-3) ",
"NDC11Code": "67046-0211-03",
"ProductNDC": "67046-0211",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propranolol Hydrochloride",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260610",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071972",
"LabelerName": "Coupler LLC",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260610",
"SamplePackage": "N",
"IndicationAndUsage": "Hypertension. Propranolol hydrochloride tablets are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride is not indicated in the management of hypertensive emergencies. Angina Pectoris Due to Coronary Atherosclerosis. Propranolol hydrochloride tablets are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Atrial Fibrillation. Propranolol hydrochloride tablets are indicated to control ventricular rate in patients with atrial fibrillation and a rapid ventricular response. Myocardial Infarction. Propranolol is indicated to reduce cardiovascular mortality in patients who have survived the acute phase of myocardial infarction and are clinically stable. Migraine. Propranolol is indicated for the prophylaxis of common migraine headache. The efficacy of propranolol in the treatment of a migraine attack that has started has not been established, and propranolol is not indicated for such use. Essential Tremor. Propranolol is indicated in the management of familial or hereditary essential tremor. Familial or essential tremor consists of involuntary, rhythmic, oscillatory movements, usually limited to the upper limbs. It is absent at rest, but occurs when the limb is held in a fixed posture or position against gravity and during active movement. Propranolol causes a reduction in the tremor amplitude, but not in the tremor frequency. Propranolol is not indicated for the treatment of tremor associated with Parkinsonism. Hypertrophic Subaortic Stenosis. Propranolol improves NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis. Pheochromocytoma. Propranolol is indicated as an adjunct to alpha-adrenergic blockade to control blood pressure and reduce symptoms of catecholamine-secreting tumors.",
"Description": "Propranolol hydrochloride, USP is a synthetic beta-adrenergic receptor blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. Its structural formula is. Propranolol hydrochloride, USP is a stable, white to off-white, crystalline powder which is readily soluble in water and ethanol. Propranolol Hydrochloride Tablets, USP are available as tablets for oral administration containing either 10 mg, 20 mg, 40 mg, 60 mg, or 80 mg of propranolol hydrochloride, USP. Propranolol Hydrochloride Tablets, USP also contain lactose anhydrous, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. Color additives include FD&C Yellow No. 6 aluminum lake (10 mg and 80 mg), D&C Yellow No. 10 aluminum lake (10 mg, 40 mg, and 80 mg), FD&C Blue No. 1 aluminum lake (20 mg and 40 mg) and FD&C Red No. 40 aluminum lake (60 mg)."
}
]
}
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<NDCList>
<NDC>
<NDCCode>67046-1136-3</NDCCode>
<PackageDescription>30 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67046-1136-3) </PackageDescription>
<NDC11Code>67046-1136-03</NDC11Code>
<ProductNDC>67046-1136</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Divalproex Sodium</ProprietaryName>
<NonProprietaryName>Divalproex Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241111</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079163</ApplicationNumber>
<LabelerName>Coupler LLC</LabelerName>
<SubstanceName>DIVALPROEX SODIUM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241111</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Divalproex sodium is an anti-epileptic drug indicated for: 1 Treatment of manic episodes associated with bipolar disorder ( 1.1) , 2 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures ( 1.2) , 3 Prophylaxis of migraine headaches ( 1.3) .</IndicationAndUsage>
<Description>Divalproex sodium, USP is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium, USP has the following structure. Divalproex sodium, USP occurs as a white powder with a characteristic odor. Divalproex sodium delayed-release tablets, USP are for oral administration. Divalproex sodium delayed-release tablets, USP are supplied in three dosage strengths containing divalproex sodium, USP equivalent to 125 mg, 250 mg, or 500 mg of valproic acid. Inactive Ingredients. Divalproex sodium delayed-release tablets, USP: Microcrystalline cellulose, opadry II white 33G28707, povidone, pregelatinized starch (contains corn starch), silicon dioxide, simethicone, talc and vanillin. Opadry II white 33G28707 consists of hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide and triacetin. Imprinting ink contains ethanol, shellac glaze, iron oxide black, isopropyl alcohol, N-butyl alcohol and propylene glycol. In addition, individual tablets contain. 125 mg tablets: Acryl EZE Orange which consists of FD & C Yellow No. 6, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate & yellow iron oxide. 250 mg tablets: Acryl EZE Pink which consists of D & C Red No. 30, FD & C Blue No. 2, iron oxide red, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate. 500 mg tablets: Acryl EZE Pink which consists of FD & C Red No. 40, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate.</Description>
</NDC>
<NDC>
<NDCCode>36987-1136-3</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (36987-1136-3)</PackageDescription>
<NDC11Code>36987-1136-03</NDC11Code>
<ProductNDC>36987-1136</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Egg Yolk</ProprietaryName>
<NonProprietaryName>Egg Yolk</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>EGG YOLK</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Egg Proteins, Dietary [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>37662-1136-3</NDCCode>
<PackageDescription>3000 PELLET in 1 BOTTLE, GLASS (37662-1136-3) </PackageDescription>
<NDC11Code>37662-1136-03</NDC11Code>
<ProductNDC>37662-1136</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Manganum Muriaticum</ProprietaryName>
<NonProprietaryName>Manganum Muriaticum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220801</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>MANGANESE CHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Pharm_Classes>Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>64942-1136-3</NDCCode>
<PackageDescription>14 g in 1 CONTAINER (64942-1136-3)</PackageDescription>
<NDC11Code>64942-1136-03</NDC11Code>
<ProductNDC>64942-1136</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Degree</ProprietaryName>
<ProprietaryNameSuffix>Cotton Fresh Antiperspirant And Deodorant</ProprietaryNameSuffix>
<NonProprietaryName>Aluminum Zirconium Tetrachlorohydrex Gly</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20101215</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part350</ApplicationNumber>
<LabelerName>Conopco Inc. d/b/a Unilever</LabelerName>
<SubstanceName>ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY</SubstanceName>
<StrengthNumber>18.2</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>70677-1136-3</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (70677-1136-3) </PackageDescription>
<NDC11Code>70677-1136-03</NDC11Code>
<ProductNDC>70677-1136</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Foster And Thrive Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231020</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072096</ApplicationNumber>
<LabelerName>Strategic Sourcing Services LLC</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231020</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to:headachemuscular achesminor pain of arthritistoothachebackache the common coldmenstrual cramps. temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71335-1136-3</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (71335-1136-3) </PackageDescription>
<NDC11Code>71335-1136-03</NDC11Code>
<ProductNDC>71335-1136</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Losartan Potassium</ProprietaryName>
<NonProprietaryName>Losartan Potassium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091541</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>LOSARTAN POTASSIUM</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190304</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Losartan potassium tablet is an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. ( 1.2) , 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. ( 1.3) .</IndicationAndUsage>
<Description>Losartan potassium tablets USP is an angiotensin II receptor blocker acting on the AT 1 receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[ p-( o-1 Htetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its molecular formula is C 22H 22ClKN 6O, and its structural formula is:. Losartan potassium USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: Microcrystalline cellulose, lactose monohydrate, pregelatinized starch, magnesium stearate, Opadry white (hydroxypropyl cellulose, hypromellose and titanium dioxide). Losartan potassium 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively.</Description>
</NDC>
<NDC>
<NDCCode>0093-1136-56</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (0093-1136-56) </PackageDescription>
<NDC11Code>00093-1136-56</NDC11Code>
<ProductNDC>0093-1136</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acitretin</ProprietaryName>
<NonProprietaryName>Acitretin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130719</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091455</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>ACITRETIN</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130719</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acitretin Capsules are indicated for the treatment of severe psoriasis in adults. Because of significant adverse effects associated with its use, Acitretin Capsules should be prescribed only by those knowledgeable in the systemic use of retinoids. In females of reproductive potential, Acitretin Capsules should be reserved for non-pregnant patients who are unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments (see boxed CONTRAINDICATIONS AND WARNINGS — Acitretin Capsules can cause severe birth defects). Most patients experience relapse of psoriasis after discontinuing therapy. Subsequent courses, when clinically indicated, have produced efficacy results similar to the initial course of therapy.</IndicationAndUsage>
<Description>Acitretin, USP (micronized), a retinoid, is available in 10 mg, 17.5 mg, and 25 mg gelatin capsules for oral administration. Chemically, acitretin is all-trans-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethyl-2,4,6,8-nonatetraenoic acid. It is a metabolite of etretinate and is related to both retinoic acid and retinol (vitamin A). It is a yellow to greenish-yellow crystalline powder. The structural formula is. C21H26O3 M.W. 326.43. Each capsule contains acitretin, USP (micronized) 10 mg, 17.5 mg, and 25 mg. Inactive ingredients are crospovidone, microcrystalline cellulose, poloxamer, povidone, sodium ascorbate and sodium lauryl sulfate. The 10 mg, 17.5, and 25 mg gelatin capsule shells contain gelatin and titanium dioxide. The 10 mg and 25 mg capsule shells also contain D&C yellow no. 10, FD&C blue no. 1, and FD&C red no. 40. The 17.5 mg capsule shells also contain red iron oxide and yellow iron oxide. The 25 mg gelatin capsule shells also contain FD&C yellow no. 6. The edible imprinting ink contains black iron oxide, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, propylene glycol and shellac glaze. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>17856-1136-1</NDCCode>
<PackageDescription>15 g in 1 POUCH (17856-1136-1) </PackageDescription>
<NDC11Code>17856-1136-01</NDC11Code>
<ProductNDC>17856-1136</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Polystyrene Sulfonate</ProprietaryName>
<NonProprietaryName>Sodium Polystyrene Sulfonate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>ORAL; RECTAL</RouteName>
<StartMarketingDate>20120725</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040905</ApplicationNumber>
<LabelerName>ATLANTIC BIOLOGICALS CORP</LabelerName>
<SubstanceName>SODIUM POLYSTYRENE SULFONATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160923</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sodium Polystyrene Sulfonate, USP is indicated for the treatment of hyperkalemia.</IndicationAndUsage>
<Description>Sodium Polystyrene Sulfonate, USP, is a benzene, diethenyl-polymer, with ethenylbenzene, sulfonated, sodium salt and has the following structural formula. The drug is a cream to light brown finely ground, powdered form of sodium polystyrene sulfonate, a cation-exchange resin prepared in the sodium phase with an in vitro exchange capacity of approximately 3.1 mEq (in vivo approximately 1 mEq) of potassium per gram. The sodium content is approximately 100 mg (4.1 mEq) per gram of the drug. It can be administered orally or in an enema.</Description>
</NDC>
<NDC>
<NDCCode>33992-1136-1</NDCCode>
<PackageDescription>42.5 g in 1 TUBE (33992-1136-1) </PackageDescription>
<NDC11Code>33992-1136-01</NDC11Code>
<ProductNDC>33992-1136</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Assured</ProprietaryName>
<ProprietaryNameSuffix>Muscle Rub</ProprietaryNameSuffix>
<NonProprietaryName>Menthol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120515</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Greenbrier International, Inc.</LabelerName>
<SubstanceName>MENTHOL, UNSPECIFIED FORM</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves the minor aches and pains in muscles and joints associated with: 1 simple backache, 2 arthritis, 3 strains, 4 bruises, 5 sprains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50090-1136-0</NDCCode>
<PackageDescription>5 mL in 1 BOTTLE (50090-1136-0) </PackageDescription>
<NDC11Code>50090-1136-00</NDC11Code>
<ProductNDC>50090-1136</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tobramycin And Dexamethasone</ProprietaryName>
<NonProprietaryName>Tobramycin And Dexamethasone</NonProprietaryName>
<DosageFormName>SUSPENSION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20090102</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA050592</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>TOBRAMYCIN; DEXAMETHASONE</SubstanceName>
<StrengthNumber>3; 1</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tobramycin and dexamethasone ophthalmic suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. The particular anti-infective drug in this product is active against the following common bacterial eye pathogens. Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains. Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae. Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae and H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria species.</IndicationAndUsage>
<Description>Tobramycin and dexamethasone ophthalmic suspension is a sterile, multiple dose antibiotic and steroid combination for topical ophthalmic use. The chemical structures for tobramycin and dexamethasone are presented below. Tobramycin Empirical Formula: C18H37N5O9. Chemical Name: O-3-Amino-3-deoxy-α- D-glucopyranosyl-(1→4)-O-[2,6-diamino-2,3,6-trideoxy-α-D-ribo-hexopyranosyl- (1→6)]-2-deoxy-L-streptamine. Molecular Weight: 467.52. Dexamethasone Empirical Formula: C22H29FO5. Chemical Name: 9-Fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione. Molecular Weight: 392.47. Each mL of tobramycin and dexamethasone ophthalmic suspension contains: Actives: tobramycin 0.3% (3 mg) and dexamethasone 0.1% (1 mg). Preservative: benzalkonium chloride 0.01%. Inactives: edetate disodium, hydroxyethyl cellulose, purified water, sodium chloride, sodium sulfate, sulfuric acid and/or sodium hydroxide (to adjust pH), and tyloxapol.</Description>
</NDC>
<NDC>
<NDCCode>67046-0003-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (67046-0003-3) </PackageDescription>
<NDC11Code>67046-0003-03</NDC11Code>
<ProductNDC>67046-0003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mirtazapine</ProprietaryName>
<NonProprietaryName>Mirtazapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241218</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076921</ApplicationNumber>
<LabelerName>Coupler LLC</LabelerName>
<SubstanceName>MIRTAZAPINE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>67046-0007-3</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (67046-0007-3) </PackageDescription>
<NDC11Code>67046-0007-03</NDC11Code>
<ProductNDC>67046-0007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alprazolam</ProprietaryName>
<NonProprietaryName>Alprazolam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260505</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203346</ApplicationNumber>
<LabelerName>Coupler LLC</LabelerName>
<SubstanceName>ALPRAZOLAM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260505</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alprazolam tablets are indicated for the: : 1 acute treatment of generalized anxiety disorder (GAD) in adults., 2 treatment of panic disorder (PD), with or without agoraphobia in adults.</IndicationAndUsage>
<Description>Alprazolam tablets, USP contain alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The structural formula is. Alprazolam USP is a white to off-white, crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. Each alprazolam tablet USP, for oral administration, contains 0.25 mg, 0.5 mg, 1 mg, or 2 mg of alprazolam USP. Inactive ingredients: colloidal silicon dioxide, corn starch, docusate sodium 85% with sodium benzoate 15%, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. In addition, the 0.5 mg tablet contains FD&C Yellow # 6 aluminum lake and the 1 mg tablet contains FD&C Blue No. 2 lake.</Description>
</NDC>
<NDC>
<NDCCode>67046-0015-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (67046-0015-3) </PackageDescription>
<NDC11Code>67046-0015-03</NDC11Code>
<ProductNDC>67046-0015</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260424</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065256</ApplicationNumber>
<LabelerName>Coupler LLC</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>875</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260424</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults and Pediatric Patients: 1 Upper Respiratory Tract Infections of the Ear, Nose, and Throat:Amoxicillin tablets are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcusspecies. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcusspp., or Haemophilus influenzae. .</IndicationAndUsage>
<Description>Amoxicillin tablets, USP are a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl) acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin molecular formula is C 16H 19N 3O 5S 3H 2O, and the molecular weight is 419.45. Each film coated tablet contains 500 mg or 875 mg amoxicillin USP as the trihydrate. The 500 mg pink colored, capsule shaped, film coated tablets debossed with “A” on one side and “66” on the other side. The 875 mg pink colored, capsule shaped, film coated tablets debossed with “A” on one side and with a score line in between “6” and “7” on the other side. Inactive ingredients: Colloidal silicon dioxide, crospovidone, D&C Red No. 30 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>67046-0038-3</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (67046-0038-3) </PackageDescription>
<NDC11Code>67046-0038-03</NDC11Code>
<ProductNDC>67046-0038</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quetiapine Fumarate</ProprietaryName>
<NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241218</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201504</ApplicationNumber>
<LabelerName>Coupler LLC</LabelerName>
<SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Quetiapine is an atypical antipsychotic indicated for the treatment of. · Schizophrenia ( 1.1). · Bipolar I disorder manic episodes ( 1.2). · Bipolar disorder, depressive episodes ( 1.2).</IndicationAndUsage>
<Description>Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [ b,f] [1,4]thiazepin-11-yl-1-piperazinyl) ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C 42H 50N 6O 4S 2C 4H 4O 4and it has a molecular weight of 883.11 (fumarate salt). The structural formula is:. Quetiapine fumarate USP is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablets, USP is supplied for oral administration as 25 mg (round peach), 50 mg (round, white), 100 mg (round yellow), 150 mg (round, off white to light yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are povidone, dibasic dicalcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, hypromellose, polyethylene glycol and titanium dioxide. The 25 mg tablets contain red iron oxide and yellow iron oxide and the 100 mg, 150 mg and 400 mg tablets contain only yellow iron oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate USP equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate USP equivalent to 100 mg quetiapine. Each 150 mg tablet contains 172.70 mg of quetiapine fumarate USP equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.27 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.40 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.54 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine.</Description>
</NDC>
<NDC>
<NDCCode>67046-0040-3</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (67046-0040-3) </PackageDescription>
<NDC11Code>67046-0040-03</NDC11Code>
<ProductNDC>67046-0040</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benztropine Mesylate</ProprietaryName>
<NonProprietaryName>Benztropine Mesylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260526</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040715</ApplicationNumber>
<LabelerName>Coupler LLC</LabelerName>
<SubstanceName>BENZTROPINE MESYLATE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Antihistamine [EPC], Cholinergic Antagonists [MoA], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260526</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For use as an adjunct in the therapy of all forms of parkinsonism. Useful also in the control of extrapyramidal disorders (except tardive dyskinesia – see PRECAUTIONS) due to neuroleptic drugs (e.g., phenothiazines).</IndicationAndUsage>
<Description>Benztropine mesylate is a synthetic compound containing structural features found in atropine and diphenhydramine. It is a crystalline white powder, very soluble in water, designated as 3α-(Diphenylmethoxy)-1αH, 5αH-tropane methanesulfonate, with the following structural formula. Each tablet, for oral administration, contains 0.5 mg, 1 mg or 2 mg of benztropine mesylate. Each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate, lactose monohydrate, magnesium stearate and microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>67046-0041-3</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (67046-0041-3) </PackageDescription>
<NDC11Code>67046-0041-03</NDC11Code>
<ProductNDC>67046-0041</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benztropine Mesylate</ProprietaryName>
<NonProprietaryName>Benztropine Mesylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260424</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040715</ApplicationNumber>
<LabelerName>Coupler LLC</LabelerName>
<SubstanceName>BENZTROPINE MESYLATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Antihistamine [EPC], Cholinergic Antagonists [MoA], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260424</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For use as an adjunct in the therapy of all forms of parkinsonism. Useful also in the control of extrapyramidal disorders (except tardive dyskinesia – see PRECAUTIONS) due to neuroleptic drugs (e.g., phenothiazines).</IndicationAndUsage>
<Description>Benztropine mesylate is a synthetic compound containing structural features found in atropine and diphenhydramine. It is a crystalline white powder, very soluble in water, designated as 3α-(Diphenylmethoxy)-1αH, 5αH-tropane methanesulfonate, with the following structural formula. Each tablet, for oral administration, contains 0.5 mg, 1 mg or 2 mg of benztropine mesylate. Each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate, lactose monohydrate, magnesium stearate and microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>67046-0053-3</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (67046-0053-3) </PackageDescription>
<NDC11Code>67046-0053-03</NDC11Code>
<ProductNDC>67046-0053</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Haloperidol</ProprietaryName>
<NonProprietaryName>Haloperidol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250702</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071173</ApplicationNumber>
<LabelerName>Coupler LLC</LabelerName>
<SubstanceName>HALOPERIDOL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Typical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250702</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Haloperidol tablets, USP are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets, USP are indicated for the control of tics and vocal utterances of Tourette’s Disorder in children and adults. Haloperidol tablets, USP are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol tablets, USP are also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidol tablets, USP should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics.</IndicationAndUsage>
<Description>Haloperidol is the first of the butyrophenone series of major tranquilizers. The chemical designation is 4-[4-(p-chloro-phenyl)-4-hydroxypiperidino]-4’—fluorobutyrophenone and it has the following structural formula. C21H23ClFNO2375.87. Haloperidol is supplied as tablets for oral administration containing 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg or 20 mg of haloperidol, USP and contains the following inactive ingredients: magnesium stearate, microcrystalline cellulose, pregelatinized starch. In addition, the 1 mg, 5 mg and 10 mg tablets contain D&C Yellow No. 10 Aluminum Lake. The 5 mg and 10 mg tablets contain FD&C Blue No. 1 Aluminum Lake, 20 mg tablets contain FD&C Red No. 40 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>67046-0057-3</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (67046-0057-3) </PackageDescription>
<NDC11Code>67046-0057-03</NDC11Code>
<ProductNDC>67046-0057</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meloxicam</ProprietaryName>
<NonProprietaryName>Meloxicam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260427</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077921</ApplicationNumber>
<LabelerName>Coupler LLC</LabelerName>
<SubstanceName>MELOXICAM</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260427</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Meloxicam Tablets are non-steroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) ( 1.1) , 2 Rheumatoid Arthritis (RA) ( 1.2) , 3 Juvenile Rheumatoid Arthritis (JRA) in patients who weigh ≥ 60 kg ( 1.3) .</IndicationAndUsage>
<Description>Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID). Each yellow meloxicam tablet contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl- N-(5-methyl-2-thiazolyl)-2 H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14H 13N 3O 4S 2and it has the following structural formula. Meloxicam, USP is a pale yellow powder, practically insoluble in water, slightly soluble in acetone, soluble in dimethylformamide, very slightly soluble in ethanol (96 %) and in methanol. Meloxicam has an apparent partition coefficient (log P) app= 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Each meloxicam tablet, USP intended for oral administration contains 7.5 mg or 15 mg of meloxicam. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium citrate dihydrate.</Description>
</NDC>
<NDC>
<NDCCode>67046-0059-3</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (67046-0059-3) </PackageDescription>
<NDC11Code>67046-0059-03</NDC11Code>
<ProductNDC>67046-0059</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenobarbital</ProprietaryName>
<NonProprietaryName>Phenobarbital</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260622</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Coupler LLC</LabelerName>
<SubstanceName>PHENOBARBITAL</SubstanceName>
<StrengthNumber>32.4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260622</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1. Sedative 2. Anticonvulsant - For the treatment of generalized and partial seizures.</IndicationAndUsage>
<Description>The barbiturates are nonselective central nervous system (CNS) depressants that are primarily used as sedative-hypnotics. In subhypnotic doses, they are also used as anticonvulsants. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act. Phenobarbital is a barbituric acid derivative and occurs as white, odorless, small crystals or crystalline powder that is very slightly soluble in water; soluble in alcohol, in ether, and in solutions of fixed alkali hydroxides and carbonates; sparingly soluble in chloroform. Phenobarbital is 5-ethyl-5- phenylbarbituric acid. Phenobarbital is a substituted pyrimidine derivative in which the basic structure is barbituric acid, a substance that has no CNS activity. CNS activity is obtained by substituting alkyl, alkenyl, or aryl groups on the pyrimidine ring. It has the following structural formula:. C 12H 12N 2O 3 M.W. = 232.24 Each phenobarbital tablet contains 16.2 mg, 32.4 mg, 64.8 mg, or 97.2 mg of phenobarbital, USP. Inactive ingredients include:colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>67046-0060-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (67046-0060-3) </PackageDescription>
<NDC11Code>67046-0060-03</NDC11Code>
<ProductNDC>67046-0060</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naltrexone Hydrochloride</ProprietaryName>
<NonProprietaryName>Naltrexone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260527</StartMarketingDate>
<EndMarketingDate>20271130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075274</ApplicationNumber>
<LabelerName>Coupler LLC</LabelerName>
<SubstanceName>NALTREXONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Opioid Antagonist [EPC], Opioid Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20260527</StartMarketingDatePackage>
<EndMarketingDatePackage>20271130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naltrexone Hydrochloride Tablets USP are indicated in the treatment of alcohol dependence and for the blockade of the effects of exogenously administered opioids. Naltrexone Hydrochloride Tablets USP have not been shown to provide any therapeutic benefit except as part of an appropriate plan of management for the addictions.</IndicationAndUsage>
<Description>Naltrexone hydrochloride, an opioid antagonist, are a synthetic congener of oxymorphone with no opioid agonist properties. Naltrexone differs in structure from oxymorphone in that the methyl group on the nitrogen atom is replaced by a cyclopropylmethyl group. Naltrexone hydrochloride is also related to the potent opioid antagonist, naloxone, or n-allylnoroxymorphone. The chemical name for naltrexone hydrochloride is Morphinan-6-one, 17-(cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxy-, hydrochloride, (5a)-. The structural formula is as follows. Naltrexone hydrochloride is a white, crystalline compound. The hydrochloride salt is soluble in water to the extent of about 100 mg/mL. Naltrexone Hydrochloride Tablets USP are available in scored film-coated tablets containing 50 mg of naltrexone hydrochloride. Naltrexone Hydrochloride Tablets USP also contain: carnauba wax powder, colloidal silicon dioxide, croscarmellose sodium, hypromellose, hydroxypropyl cellulose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>67046-0068-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (67046-0068-3) </PackageDescription>
<NDC11Code>67046-0068-03</NDC11Code>
<ProductNDC>67046-0068</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mirtazapine</ProprietaryName>
<NonProprietaryName>Mirtazapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260427</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076921</ApplicationNumber>
<LabelerName>Coupler LLC</LabelerName>
<SubstanceName>MIRTAZAPINE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-04-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260427</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Mirtazapine tablets, USP contain mirtazapine USP. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro-2-methylpyrazino [2,1-a] pyrido [2,3-c][2] benzazepine and has the molecular formula of C 17H 19N 3. Its molecular weight is 265.35. The structural formula is the following and it is the racemic mixture:. Mirtazapine is a white to creamy white crystalline powder which is practically insoluble in water. Mirtazapine tablets, USP are available for oral administration as scored film-coated tablets containing 15 or 30 mg of mirtazapine USP, and unscored film-coated tablets containing 7.5 or 45 mg of mirtazapine USP. Each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, and titanium dioxide. In addition, the 15 mg contains iron oxide yellow and 30 mg contains iron oxide red, iron oxide black, and iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>67046-0072-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (67046-0072-3) </PackageDescription>
<NDC11Code>67046-0072-03</NDC11Code>
<ProductNDC>67046-0072</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260619</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202862</ApplicationNumber>
<LabelerName>Coupler LLC</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260619</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated. As oral formulation for the:. · Treatment of schizophrenia. ( 1.1). · Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. ( 14.1). · Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia ( 14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.1). · Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. ( 1.2). · Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. ( 14.2). · Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder ( 14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.2). · Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. ( 1.3). · Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. ( 1.2). · Efficacy was established in two 6-week clinical trials in adults ( 14.2). Maintenance efficacy has not been systematically evaluated. As Olanzapine and Fluoxetine in Combination for the: Treatment of depressive episodes associated with bipolar I disorder. ( 1.5) Efficacy was established with Symbyax (olanzapine and fluoxetine in combination); refer to the product label for Symbyax. Treatment of treatment resistant depression. ( 1.6) Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.</IndicationAndUsage>
<Description>Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose. The color coating contains Titanium Dioxide (all strengths), FD&C Blue No. 2 indigo carmine Aluminum Lake (15 mg), or Synthetic Red Iron Oxide (20 mg).</Description>
</NDC>
<NDC>
<NDCCode>67046-0113-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (67046-0113-3) </PackageDescription>
<NDC11Code>67046-0113-03</NDC11Code>
<ProductNDC>67046-0113</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Citalopram</ProprietaryName>
<NonProprietaryName>Citalopram</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260610</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078216</ApplicationNumber>
<LabelerName>Coupler LLC</LabelerName>
<SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies ( 14)] .</IndicationAndUsage>
<Description>Citalopram tablets, USP contain citalopram, a selective serotonin reuptake inhibitor (SSRI). Citalopram hydrobromide is a racemic bicyclic phthalane structure and is designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3dihydroisobenzofuran-5-carbonitrile hydrobromide with the following structural formula. The molecular formula is C 20H 22BrFN 2O and its molecular weight is 405.35. Citalopram hydrobromide, USP occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol. Citalopram, USP 10 mg tablets are film-coated, round shaped tablets containing citalopram hydrobromide in strengths equivalent to 10 mg citalopram base. Citalopram hydrobromide, USP 20 mg and 40 mg tablets are film-coated, oval shaped, scored tablets containing citalopram hydrobromide, in strengths equivalent to 20 mg or 40 mg citalopram base. The tablets also contain the following inactive ingredients: copovidone, corn starch, croscarmellose sodium, ferric oxide red, ferric oxide yellow, glycerin, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>67046-0127-3</NDCCode>
<PackageDescription>30 CAPSULE in 1 BLISTER PACK (67046-0127-3) </PackageDescription>
<NDC11Code>67046-0127-03</NDC11Code>
<ProductNDC>67046-0127</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260504</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064076</ApplicationNumber>
<LabelerName>Coupler LLC</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260504</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults and Pediatric Patients: 1 Upper Respiratory Tract Infections of the Ear, Nose, and Throat.</IndicationAndUsage>
<Description>Amoxicillin is a semisynthetic antibacterial, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[(R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4- thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin molecular formula is C 16H 19N 3O 5S 3H 2O, and the molecular weight is 419.45. Amoxicillin Capsules, USP. Each amoxicillin capsule, with yellow opaque cap and body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The 250 mg capsule is imprinted AMOX 250 on one side and GG 848 on the other side; the 500 mg capsule is imprinted AMOX 500 on one side and GG 849 on the other side. Inactive ingredients: Capsule shells - yellow ferric oxide, titanium dioxide, gelatin, black ferric oxide, shellac, propylene glycol, potassium hydroxide and ammonium hydroxide; Capsule contents - cellulose microcrystalline and magnesium stearate. Meets USP Dissolution Test 2. Amoxicillin Tablets, USP. Each film coated tablet contains 500 mg or 875 mg of amoxicillin as the trihydrate. The tablets are oval-shaped and white to yellowish. The 500 mg tablet is unscored, embossed GG-961 on one side and 500 on the other side. The 875 mg tablet is scored and embossed GG-962 on one side and 875 on the other side. In addition each amoxicillin tablet contains these inactive ingredients in each 500 mg or 875 mg tablet: colloidal silicon dioxide, crospovidone, ethylcellulose aqueous dispersion, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, talc, triethyl citrate, and titanium dioxide. Amoxicillin for Oral Suspension, USP. Each 5 mL of reconstituted suspension contains 125 mg, 200 mg, 250 mg or 400 mg amoxicillin as the trihydrate. Each 5 mL of the 125 mg, 200 mg, 250 mg, and 400 mg reconstituted suspension contains 0.30 mEq (6.95 mg) of sodium. Amoxicillin trihydrate for oral suspension 125 mg/5 mL, 200 mg/5 mL, 250 mg/5 mL and 400 mg/5 mL are fruity flavored pink suspensions. Inactive ingredients: anhydrous citric acid, colloidal silicon dioxide, flavorings: raspberry, strawberry, refrachessement, FD&C Red 40, sodium benzoate, sodium citrate, sucrose, and xantham gum.</Description>
</NDC>
<NDC>
<NDCCode>67046-0135-3</NDCCode>
<PackageDescription>30 CAPSULE in 1 BLISTER PACK (67046-0135-3) </PackageDescription>
<NDC11Code>67046-0135-03</NDC11Code>
<ProductNDC>67046-0135</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline Hyclate</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260526</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062396</ApplicationNumber>
<LabelerName>Coupler LLC</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260526</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate capsules and other antibacterial drugs, doxycycline hyclate capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Doxycycline Hyclate Capsules, USP is an antibacterial drug synthetically derived from oxytetracycline. The structural formula of doxycycline hyclate is. with a molecular formula of (C 22H 24N 2O 8HCL) 2C 2H 6OH 2O and a molecular weight of 1025.88. The chemical designation for doxycycline is 2-Naphthacenecarboxamide, 4-(dimethylamino)-1, 4, 4a, 5, 5a, 6, -11, 12a-octahydro-3,5,10, 12, 12a-pentahydroxy-6-methyl-1, 11-dioxo-monohydrochloride, compound with ethanol(2:1), monohydrate, [4s-(4α, 4aα, 5α, 5aα, 6α, 12aα)]. Doxycycline is a yellow crystalline powder. Doxycycline hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each capsule for oral administration contains doxycycline hyclate equivalent to 50 mg or 100 mg of doxycycline (anhydrous). Inactive ingredients: lactose monohydrate, microcrystalline cellulose, magnesium stearate. The 50 mg and 100 mg capsule shells contain: gelatin, FD&C Blue #1 and titanium dioxide. The printing ink may contain: Shellac Glaze, Iron Oxide Black, N-Butyl Alcohol, Propylene Glycol, SD-45 Alcohol, FD&C Blue #2, FD&C Red #40, FD&C Blue #1, D&C Yellow #10.</Description>
</NDC>
<NDC>
<NDCCode>67046-0154-3</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (67046-0154-3) </PackageDescription>
<NDC11Code>67046-0154-03</NDC11Code>
<ProductNDC>67046-0154</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alprazolam</ProprietaryName>
<NonProprietaryName>Alprazolam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260429</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203346</ApplicationNumber>
<LabelerName>Coupler LLC</LabelerName>
<SubstanceName>ALPRAZOLAM</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260429</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alprazolam tablets are indicated for the: : 1 acute treatment of generalized anxiety disorder (GAD) in adults., 2 treatment of panic disorder (PD), with or without agoraphobia in adults.</IndicationAndUsage>
<Description>Alprazolam tablets, USP contain alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The structural formula is. Alprazolam USP is a white to off-white, crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. Each alprazolam tablet USP, for oral administration, contains 0.25 mg, 0.5 mg, 1 mg, or 2 mg of alprazolam USP. Inactive ingredients: colloidal silicon dioxide, corn starch, docusate sodium 85% with sodium benzoate 15%, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. In addition, the 0.5 mg tablet contains FD&C Yellow # 6 aluminum lake and the 1 mg tablet contains FD&C Blue No. 2 lake.</Description>
</NDC>
<NDC>
<NDCCode>67046-0155-3</NDCCode>
<PackageDescription>30 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67046-0155-3) </PackageDescription>
<NDC11Code>67046-0155-03</NDC11Code>
<ProductNDC>67046-0155</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole Sodium</ProprietaryName>
<NonProprietaryName>Pantoprazole</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241106</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202882</ApplicationNumber>
<LabelerName>Coupler LLC</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pantoprazole sodium delayed-release tablets are indicated for.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>67046-0179-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (67046-0179-3) </PackageDescription>
<NDC11Code>67046-0179-03</NDC11Code>
<ProductNDC>67046-0179</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxcarbazepine</ProprietaryName>
<NonProprietaryName>Oxcarbazepine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260428</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077802</ApplicationNumber>
<LabelerName>Coupler LLC</LabelerName>
<SubstanceName>OXCARBAZEPINE</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260428</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxcarbazepine tablets are indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures.</IndicationAndUsage>
<Description>Oxcarbazepine Tablets USP are an antiepileptic drug available as 150 mg, 300 mg, and 600 mg film-coated tablets for oral administration. Oxcarbazepine, USP is 10,11-Dihydro-10-oxo- 5H-dibenz[b, f]azepine-5-carboxamide, and its structural formula is:. Oxcarbazepine, USP is a light orange to creamish white or off-white powder. It is soluble in acetic acid, sparingly soluble in chloroform, practically insoluble in water. Its molecular weight is 252.27 g/mol. Oxcarbazepine film-coated tablets contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, ferric oxide (yellow), hypromellose, magnesium stearate, meglumine, microcrystalline cellulose, polyethylene glycol, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>67046-0186-3</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (67046-0186-3) </PackageDescription>
<NDC11Code>67046-0186-03</NDC11Code>
<ProductNDC>67046-0186</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoclopramide</ProprietaryName>
<NonProprietaryName>Metoclopramide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260602</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072801</ApplicationNumber>
<LabelerName>Coupler LLC</LabelerName>
<SubstanceName>METOCLOPRAMIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine D2 Antagonists [MoA], Dopamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260602</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoclopramide tablets are indicated for the: 1 Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy., 2 Relief of symptoms in adults with acute and recurrent diabetic gastroparesis.</IndicationAndUsage>
<Description>Metoclopramide hydrochloride, USP, the active ingredient of metoclopramide tablets, USP is a dopamine-2 receptor antagonist. Metoclopramide hydrochloride (metoclopramide monohydrochloride monohydrate) is a white or practically white, crystalline, odorless or practically odorless powder. It is very soluble in water, freely soluble in alcohol, sparingly soluble in chloroform and practically insoluble in ether. Chemically, it is 4-amino-5-chloro- N-[2-(diethylamino)ethyl]-2-methoxy benzamide monohydrochloride monohydrate. Its structural formula is as follows:. C 14H 22ClN 3O 2HClH 2O M.W. 354.3. Metoclopramide tablets, USP are for oral administration. Metoclopramide tablets, USP are available in 5 mg and 10 mg tablets. : 1 Each metoclopramide tablet USP, 5 mg contains 5 mg metoclopramide (equivalent to 5.91 mg of metoclopramide hydrochloride, USP)., 2 Each metoclopramide tablet USP, 10 mg contains 10 mg metoclopramide (equivalent to 11.82 mg of metoclopramide hydrochloride, USP).</Description>
</NDC>
<NDC>
<NDCCode>67046-0211-3</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (67046-0211-3) </PackageDescription>
<NDC11Code>67046-0211-03</NDC11Code>
<ProductNDC>67046-0211</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260610</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071972</ApplicationNumber>
<LabelerName>Coupler LLC</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypertension. Propranolol hydrochloride tablets are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride is not indicated in the management of hypertensive emergencies. Angina Pectoris Due to Coronary Atherosclerosis. Propranolol hydrochloride tablets are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Atrial Fibrillation. Propranolol hydrochloride tablets are indicated to control ventricular rate in patients with atrial fibrillation and a rapid ventricular response. Myocardial Infarction. Propranolol is indicated to reduce cardiovascular mortality in patients who have survived the acute phase of myocardial infarction and are clinically stable. Migraine. Propranolol is indicated for the prophylaxis of common migraine headache. The efficacy of propranolol in the treatment of a migraine attack that has started has not been established, and propranolol is not indicated for such use. Essential Tremor. Propranolol is indicated in the management of familial or hereditary essential tremor. Familial or essential tremor consists of involuntary, rhythmic, oscillatory movements, usually limited to the upper limbs. It is absent at rest, but occurs when the limb is held in a fixed posture or position against gravity and during active movement. Propranolol causes a reduction in the tremor amplitude, but not in the tremor frequency. Propranolol is not indicated for the treatment of tremor associated with Parkinsonism. Hypertrophic Subaortic Stenosis. Propranolol improves NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis. Pheochromocytoma. Propranolol is indicated as an adjunct to alpha-adrenergic blockade to control blood pressure and reduce symptoms of catecholamine-secreting tumors.</IndicationAndUsage>
<Description>Propranolol hydrochloride, USP is a synthetic beta-adrenergic receptor blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. Its structural formula is. Propranolol hydrochloride, USP is a stable, white to off-white, crystalline powder which is readily soluble in water and ethanol. Propranolol Hydrochloride Tablets, USP are available as tablets for oral administration containing either 10 mg, 20 mg, 40 mg, 60 mg, or 80 mg of propranolol hydrochloride, USP. Propranolol Hydrochloride Tablets, USP also contain lactose anhydrous, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. Color additives include FD&C Yellow No. 6 aluminum lake (10 mg and 80 mg), D&C Yellow No. 10 aluminum lake (10 mg, 40 mg, and 80 mg), FD&C Blue No. 1 aluminum lake (20 mg and 40 mg) and FD&C Red No. 40 aluminum lake (60 mg).</Description>
</NDC>
</NDCList>