{
"NDC": [
{
"NDCCode": "68428-930-05",
"PackageDescription": "150 PELLET in 1 VIAL, GLASS (68428-930-05)",
"NDC11Code": "68428-0930-05",
"ProductNDC": "68428-930",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cytisus Scoparius",
"NonProprietaryName": "Cytisus Scoparius Flowering Top",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130523",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "CYTISUS SCOPARIUS FLOWERING TOP",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Indications. CYTISUS Profuse urination."
},
{
"NDCCode": "68428-930-03",
"PackageDescription": "75 PELLET in 1 VIAL, GLASS (68428-930-03)",
"NDC11Code": "68428-0930-03",
"ProductNDC": "68428-930",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cytisus Scoparius",
"NonProprietaryName": "Cytisus Scoparius Flowering Top",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130523",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "CYTISUS SCOPARIUS FLOWERING TOP",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Indications. CYTISUS Profuse urination."
},
{
"NDCCode": "68428-930-06",
"PackageDescription": "1200 PELLET in 1 BOTTLE, GLASS (68428-930-06)",
"NDC11Code": "68428-0930-06",
"ProductNDC": "68428-930",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cytisus Scoparius",
"NonProprietaryName": "Cytisus Scoparius Flowering Top",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130523",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "CYTISUS SCOPARIUS FLOWERING TOP",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Indications. CYTISUS Profuse urination."
},
{
"NDCCode": "68428-930-11",
"PackageDescription": "300 PELLET in 1 BOTTLE, GLASS (68428-930-11)",
"NDC11Code": "68428-0930-11",
"ProductNDC": "68428-930",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cytisus Scoparius",
"NonProprietaryName": "Cytisus Scoparius Flowering Top",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130523",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "CYTISUS SCOPARIUS FLOWERING TOP",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Indications. CYTISUS Profuse urination."
},
{
"NDCCode": "68428-930-12",
"PackageDescription": "600 PELLET in 1 BOTTLE, GLASS (68428-930-12)",
"NDC11Code": "68428-0930-12",
"ProductNDC": "68428-930",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cytisus Scoparius",
"NonProprietaryName": "Cytisus Scoparius Flowering Top",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130523",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "CYTISUS SCOPARIUS FLOWERING TOP",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Indications. CYTISUS Profuse urination."
},
{
"NDCCode": "40032-930-05",
"PackageDescription": "500 mL in 1 BOTTLE (40032-930-05)",
"NDC11Code": "40032-0930-05",
"ProductNDC": "40032-930",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20150814",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204602",
"LabelerName": "Novel laboratories, Inc.",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Attention Deficit Disorders, Narcolepsy. Attention Deficit Disorders (previously known as Minimal Brain Dysfunction in Children). Other terms being used to describe the behavioral syndrome below include: Hyperkinetic Child Syndrome, Minimal Brain Damage, Minimal Cerebral Dysfunction, Minor Cerebral Dysfunction. Methylphenidate Hydrochloride is indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. Special Diagnostic Considerations. Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources. Characteristics commonly reported include: chronic history of short attention span, distractibility, emotional lability, impulsivity, and moderate-to-severe hyperactivity; minor neurological signs and abnormal EEG. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of one or more of these characteristics. Drug treatment is not indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is generally necessary. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the child's symptoms.",
"Description": "Methylphenidate HCl oral solution, is a mild central nervous system (CNS) stimulant, available as 5 mg/5 mL and 10 mg/5 mL oral solutions for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is. Methylphenidate hydrochloride USP is a white to off white powder. It is soluble in water, alcohol, and chloroform. Each mL of Methylphenidate Hydrochloride Oral Solution 5 mg/5 mL contains 1 mg of methylphenidate hydrochloride USP. Each mL of Methylphenidate Hydrochloride Oral Solution 10 mg/5 mL contains 2 mg of methylphenidate hydrochloride USP. In addition, Methylphenidate Hydrochloride Oral Solution also contains the following inactive ingredients: PEG 1450, glycerin, phosphoric acid, grape flavor, and purified water."
},
{
"NDCCode": "43386-930-05",
"PackageDescription": "500 mL in 1 BOTTLE (43386-930-05) ",
"NDC11Code": "43386-0930-05",
"ProductNDC": "43386-930",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20151215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204602",
"LabelerName": "Lupin Pharmaceuticals,Inc.",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2023-12-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20151215",
"SamplePackage": "N",
"IndicationAndUsage": "Methylphenidate hydrochloride oral solution is indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years of age and older, 2 Narcolepsy.",
"Description": "Methylphenidate hydrochloride oral solution contains methylphenidate hydrochloride a CNS stimulant. It is available as an oral solution in 5 mg/5 mL and 10 mg/5 mL strengths for oral administration. Chemically, methylphenidate hydrochloride is (d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride and its structural formula is. Methylphenidate hydrochloride, USP is a white to off white powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Each mL of methylphenidate hydrochloride oral solution 5 mg/5 mL contains 1 mg of methylphenidate hydrochloride, USP. Each mL of methylphenidate hydrochloride oral solution 10 mg/5 mL contains 2 mg of methylphenidate hydrochloride USP. Methylphenidate hydrochloride oral solution also contains the following inactive ingredients: PEG 1450, glycerin, phosphoric acid grape flavor, and purified water."
},
{
"NDCCode": "49884-930-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (49884-930-05)",
"NDC11Code": "49884-0930-05",
"ProductNDC": "49884-930",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
"NonProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20110103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078381",
"LabelerName": "Par Pharmaceutical Inc.",
"SubstanceName": "AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE",
"StrengthNumber": "5; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "58657-930-05",
"PackageDescription": "5 BLISTER PACK in 1 CARTON (58657-930-05) / 10 TABLET in 1 BLISTER PACK (58657-930-10) ",
"NDC11Code": "58657-0930-05",
"ProductNDC": "58657-930",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Baclofen",
"NonProprietaryName": "Baclofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240615",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212378",
"LabelerName": "Method Pharmaceuticals LLC",
"SubstanceName": "BACLOFEN",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250601",
"SamplePackage": "N",
"IndicationAndUsage": "Baclofen tablets USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.",
"Description": "Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid, and its structural formula is. Baclofen, USP is a white to off-white odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg or 10 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, lactose monohydrate, microcrystalline cellulose, zinc stearate."
},
{
"NDCCode": "67877-930-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (67877-930-05) ",
"NDC11Code": "67877-0930-05",
"ProductNDC": "67877-930",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250825",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213320",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2025-08-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250825",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.",
"Description": "Metformin hydrochloride tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5 HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets contain 500 mg, 850 mg, or 1,000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients hypromellose, magnesium stearate, polyethylene glycol/macrogol, povidone, titanium dioxide and artificial blackberry flavor (maltodextrin, triacetin and artificial flavors). Metformin hydrochloride tablets dissolution USP Test-1 is used."
},
{
"NDCCode": "68382-930-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (68382-930-05) ",
"NDC11Code": "68382-0930-05",
"ProductNDC": "68382-930",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine And Olmesartan Medoxomil",
"NonProprietaryName": "Amlodipine And Olmesartan Medoxomil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180104",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207771",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL",
"StrengthNumber": "10; 40",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180104",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine and olmesartan medoxomil tablets are a combination of a dihydropyridine calcium channel blocker and an angiotensin II receptor blocker combination product indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1). Amlodipine and olmesartan medoxomil tablets may also be used as initial therapy in patients likely to need multiple antihypertensive agents to achieve their blood pressure goals (1).",
"Description": "Amlodipine and olmesartan medoxomil provided as a tablet for oral administration, is a combination of the calcium channel blocker (CCB) amlodipine besylate and the angiotensin II receptor blocker (ARB) olmesartan medoxomil. The amlodipine besylate component of amlodipine and olmesartan medoxomil is chemically described as 3-ethyl-5 methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5 pyridinedicarboxylate, monobenzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S. Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of amlodipine and olmesartan medoxomil is chemically described as 2,3 dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5 ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its molecular formula is C29H30N6O6. The structural formula for amlodipine besylate is. Amlodipine besylate USP is white or almost white powder, The molecular weights of amlodipine besylate is 567.05. Amlodipine besylate USP is freely soluble in methanol, sparingly soluble in anhydrous ethanol, slightly soluble in 2-propanol and in water. Olmesartan medoxomil, USP is a white or almost white crystalline powder with a molecular weight of 558.59. It is insoluble in water and sparingly soluble in methanol. Each amlodipine and olmesartan medoxomil tablet contains combination of amlodipine and olmesartan medoxomil as 5/20 mg or 10/20 mg or 5/40 mg or 10/40 mg and also contains the following inactive ingredients: anhydrous lactose, croscarmellose sodium, colloidal silicon dioxide, hypromellose, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, pregelatinized starch, polyethylene glycol, talc and titanium dioxide. Apart from this following inactive ingredients are also present. 5mg/40mg tablets: iron oxide yellow, iron oxide red, ferrosoferric oxide. 10mg/20mg tablets: iron oxide yellow, iron oxide red. 10mg/40mg tablets: iron oxide yellow, iron oxide red."
},
{
"NDCCode": "84682-930-05",
"PackageDescription": "100 g in 1 BOX (84682-930-05) ",
"NDC11Code": "84682-0930-05",
"ProductNDC": "84682-930",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Trstay Neck Face Extea Nourishing Hydrating",
"NonProprietaryName": "Trstay Neck Face Extea Nourishing Hydrating",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241107",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Yiwu Zhixin Trade Co Ltd",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241107",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "84756-930-05",
"PackageDescription": "100 g in 1 BOX (84756-930-05) ",
"NDC11Code": "84756-0930-05",
"ProductNDC": "84756-930",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Retinol Collagen Moisturizer",
"NonProprietaryName": "Retinol Collagen Moisturizer",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241213",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Yiwu Xinqian E Commerce Co Ltd",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241213",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "16714-930-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (16714-930-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "16714-0930-01",
"ProductNDC": "16714-930",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gemcitabine",
"NonProprietaryName": "Gemcitabine Hydrochloride",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20181101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091365",
"LabelerName": "NorthStar Rx LLC",
"SubstanceName": "GEMCITABINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181101",
"SamplePackage": "N",
"IndicationAndUsage": "Gemcitabine for injection is a nucleoside metabolic inhibitor indicated: : 1 in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. (1.1) , 2 in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. (1.2) , 3 in combination with cisplatin, for the treatment of non-small cell lung cancer. (1.3) , 4 as a single agent for the treatment of pancreatic cancer. (1.4) .",
"Description": "Gemcitabine is a nucleoside metabolic inhibitor. Gemcitabine hydrochloride is 2′-deoxy-2′,2′-difluorocytidine monohydrochloride (β-isomer) with the following structural formula. The empirical formula for gemcitabine hydrochloride is C9H11F2N3O4 HCl. It has a molecular weight of 299.66 g/mol. Gemcitabine HCl, USP is a white to off-white solid. It is soluble in water, slightly soluble in methanol, and practically insoluble in ethanol and polar organic solvents. Gemcitabine for injection, USP is a white to off-white, lyophilized powder and available as 200 mg and 1 g sterile single-dose vials for intravenous use only. Each 200 mg vial contains 200 mg gemcitabine hydrochloride (expressed as free base), 200 mg mannitol and 20.73 mg of sodium acetate trihydrate (equivalent to 12.5 mg of sodium acetate anhydrous). Each 1 g vial contains 1 g gemcitabine hydrochloride (expressed as free base), 1 g mannitol, and 103.5 mg of sodium acetate trihydrate (equivalent to 62.5 mg of sodium acetate anhydrous). Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment."
},
{
"NDCCode": "42858-930-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42858-930-01) ",
"NDC11Code": "42858-0930-01",
"ProductNDC": "42858-930",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate Extended-release",
"NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190822",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210651",
"LabelerName": "Rhodes Pharmaceuticals LLC",
"SubstanceName": "DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE",
"StrengthNumber": "7.5; 7.5; 7.5; 7.5",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190822",
"SamplePackage": "N",
"IndicationAndUsage": "Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules, a CNS stimulant, is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older. (1). Limitations of Use. The use of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage. (5.5, 8.4).",
"Description": "Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules contain equal amounts (by weight) of four salts: dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate. This results in a 3.1:1 mixture of dextro- to levo-amphetamine base equivalent. The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg strength extended-release capsules are for oral administration. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules are a once daily extended-release, single-entity amphetamine product. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules combine the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d, l-amphetamine aspartate monohydrate. The dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules are a dose proportional composition using a multi-layer fluid bed bead coating process, followed by encapsulation using hard gelatin capsules. The dosage utilizes a bead that is coated with an extended-release drug layer, that is then coated with an enteric polymer to control drug release, and finally coated with an immediate-release drug layer."
},
{
"NDCCode": "43063-930-20",
"PackageDescription": "20 CAPSULE in 1 BOTTLE, PLASTIC (43063-930-20) ",
"NDC11Code": "43063-0930-20",
"ProductNDC": "43063-930",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Indomethacin",
"NonProprietaryName": "Indomethacin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20101222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091276",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "INDOMETHACIN",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190109",
"SamplePackage": "N",
"IndicationAndUsage": "Indomethacin capsules are indicated for: 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease, 2 Moderate to severe ankylosing spondylitis, 3 Moderate to severe osteoarthritis, 4 Acute painful shoulder (bursitis and/or tendinitis), 5 Acute gouty arthritis.",
"Description": "Indomethacin Capsules, USP are nonsteroidal anti-inflammatory drugs, available as capsules containing 25 mg and 50 mg of indomethacin, USP, administered for oral use. The chemical name is 1-( p-chlorobenzoyl)-5-methoxy-2-methylindole-3-acetic acid. The molecular weight is 357.79 g/mol. Its molecular formula is C 19H 16ClNO 4, and it has the following chemical structure. Indomethacin, USP is a white to yellow crystalline powder. It is practically insoluble in water and sparingly soluble in alcohol, chloroform, and in ether. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The inactive ingredients in Indomethacin Capsules, USP 25 mg and 50 mg include: colloidal silicon dioxide, FD&C Blue No. 1, FD&C Yellow No. 5, gelatin, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate and titanium dioxide. The imprinting ink contains: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "51407-930-11",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (51407-930-11) / 1 SYRINGE in 1 BLISTER PACK / 1 mL in 1 SYRINGE",
"NDC11Code": "51407-0930-11",
"ProductNDC": "51407-930",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Imuldosa",
"NonProprietaryName": "Ustekinumab-srlf",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20241010",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761364",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "USTEKINUMAB-SRLF",
"StrengthNumber": "90",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250618",
"SamplePackage": "N",
"IndicationAndUsage": "IMULDOSA is a human interleukin-12 and -23 antagonist indicated for the treatment of: Adult patients with: moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. ( 1.1) active psoriatic arthritis (PsA). ( 1.2) moderately to severely active Crohn’s disease (CD). ( 1.3) moderately to severely active ulcerative colitis. ( 1.4) Pediatric patients 6 years and older with: moderate to severe plaque psoriasis (PsO), who are candidates for phototherapy or systemic therapy. ( 1.1) active psoriatic arthritis (PsA). ( 1.2).",
"Description": "Ustekinumab-srlf, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-srlf is produced in a murine cell line (Sp2/0). The manufacturing process contains steps for the clearance of viruses. Ustekinumab-srlf is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. IMULDOSA (ustekinumab-srlf) injection is a sterile, preservative-free, clear to slightly opalescent and colorless to slightly yellow solution with pH of 5.7- 6.3. IMULDOSA for Subcutaneous Use Available as 45 mg of ustekinumab-srlf in 0.5 mL and 90 mg of ustekinumab-srlf in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 29-gauge fixed ½ inch needle. The syringe is fitted with a passive needle guard and a needle cover that does not contains latex. Each 0.5 mL prefilled syringe delivers 45 mg ustekinumab-srlf, histidine (2.23 mg) and L-histidine hydrochloride monohydrate (4.14 mg), polysorbate 80 (0.02 mg), and sucrose (25.9 mg). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-srlf, histidine (4.46 mg) and L-histidine hydrochloride monohydrate (8.28 mg), polysorbate 80 (0.04 mg), and sucrose (51.8 mg). IMULDOSA for Intravenous Infusion Available as 130 mg of ustekinumab-srlf in 26 mL, supplied as a single-dose 30 mL Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-srlf, edetate disodium (0.52 mg), histidine (20 mg), L-histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), Polysorbate 80 (10.4 mg) and sucrose (2,210 mg)."
},
{
"NDCCode": "55319-930-03",
"PackageDescription": "1 BOTTLE in 1 CARTON (55319-930-03) / 118 mL in 1 BOTTLE",
"NDC11Code": "55319-0930-03",
"ProductNDC": "55319-930",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Family Wellness Childrens Pain Reliever 574",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20240418",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Family Dollar Services, Inc.",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "160",
"StrengthUnit": "mg/5mL",
"Status": "Active",
"LastUpdate": "2025-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240418",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily: : 1 reduces fever , 2 relieves minor aches and pains due to: the common coldsore throatflutoothacheheadache."
},
{
"NDCCode": "58657-930-01",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (58657-930-01) / 10 TABLET in 1 BLISTER PACK (58657-930-10) ",
"NDC11Code": "58657-0930-01",
"ProductNDC": "58657-930",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Baclofen",
"NonProprietaryName": "Baclofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240615",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212378",
"LabelerName": "Method Pharmaceuticals LLC",
"SubstanceName": "BACLOFEN",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250601",
"SamplePackage": "N",
"IndicationAndUsage": "Baclofen tablets USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.",
"Description": "Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid, and its structural formula is. Baclofen, USP is a white to off-white odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg or 10 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, lactose monohydrate, microcrystalline cellulose, zinc stearate."
},
{
"NDCCode": "66326-213-05",
"PackageDescription": "75 kg in 1 DRUM (66326-213-05) ",
"NDC11Code": "66326-0213-05",
"ProductNDC": "66326-213",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "GRANULE",
"StartMarketingDate": "20200103",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Sri Krishna Pharmaceuticals Ltd. Unit 1",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "930",
"StrengthUnit": "g/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "03-JAN-20"
},
{
"NDCCode": "68382-930-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (68382-930-01) ",
"NDC11Code": "68382-0930-01",
"ProductNDC": "68382-930",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine And Olmesartan Medoxomil",
"NonProprietaryName": "Amlodipine And Olmesartan Medoxomil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180104",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207771",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL",
"StrengthNumber": "10; 40",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180104",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine and olmesartan medoxomil tablets are a combination of a dihydropyridine calcium channel blocker and an angiotensin II receptor blocker combination product indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1). Amlodipine and olmesartan medoxomil tablets may also be used as initial therapy in patients likely to need multiple antihypertensive agents to achieve their blood pressure goals (1).",
"Description": "Amlodipine and olmesartan medoxomil provided as a tablet for oral administration, is a combination of the calcium channel blocker (CCB) amlodipine besylate and the angiotensin II receptor blocker (ARB) olmesartan medoxomil. The amlodipine besylate component of amlodipine and olmesartan medoxomil is chemically described as 3-ethyl-5 methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5 pyridinedicarboxylate, monobenzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S. Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of amlodipine and olmesartan medoxomil is chemically described as 2,3 dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5 ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its molecular formula is C29H30N6O6. The structural formula for amlodipine besylate is. Amlodipine besylate USP is white or almost white powder, The molecular weights of amlodipine besylate is 567.05. Amlodipine besylate USP is freely soluble in methanol, sparingly soluble in anhydrous ethanol, slightly soluble in 2-propanol and in water. Olmesartan medoxomil, USP is a white or almost white crystalline powder with a molecular weight of 558.59. It is insoluble in water and sparingly soluble in methanol. Each amlodipine and olmesartan medoxomil tablet contains combination of amlodipine and olmesartan medoxomil as 5/20 mg or 10/20 mg or 5/40 mg or 10/40 mg and also contains the following inactive ingredients: anhydrous lactose, croscarmellose sodium, colloidal silicon dioxide, hypromellose, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, pregelatinized starch, polyethylene glycol, talc and titanium dioxide. Apart from this following inactive ingredients are also present. 5mg/40mg tablets: iron oxide yellow, iron oxide red, ferrosoferric oxide. 10mg/20mg tablets: iron oxide yellow, iron oxide red. 10mg/40mg tablets: iron oxide yellow, iron oxide red."
},
{
"NDCCode": "68382-930-06",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (68382-930-06) ",
"NDC11Code": "68382-0930-06",
"ProductNDC": "68382-930",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine And Olmesartan Medoxomil",
"NonProprietaryName": "Amlodipine And Olmesartan Medoxomil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180104",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207771",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL",
"StrengthNumber": "10; 40",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180104",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine and olmesartan medoxomil tablets are a combination of a dihydropyridine calcium channel blocker and an angiotensin II receptor blocker combination product indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1). Amlodipine and olmesartan medoxomil tablets may also be used as initial therapy in patients likely to need multiple antihypertensive agents to achieve their blood pressure goals (1).",
"Description": "Amlodipine and olmesartan medoxomil provided as a tablet for oral administration, is a combination of the calcium channel blocker (CCB) amlodipine besylate and the angiotensin II receptor blocker (ARB) olmesartan medoxomil. The amlodipine besylate component of amlodipine and olmesartan medoxomil is chemically described as 3-ethyl-5 methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5 pyridinedicarboxylate, monobenzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S. Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of amlodipine and olmesartan medoxomil is chemically described as 2,3 dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5 ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its molecular formula is C29H30N6O6. The structural formula for amlodipine besylate is. Amlodipine besylate USP is white or almost white powder, The molecular weights of amlodipine besylate is 567.05. Amlodipine besylate USP is freely soluble in methanol, sparingly soluble in anhydrous ethanol, slightly soluble in 2-propanol and in water. Olmesartan medoxomil, USP is a white or almost white crystalline powder with a molecular weight of 558.59. It is insoluble in water and sparingly soluble in methanol. Each amlodipine and olmesartan medoxomil tablet contains combination of amlodipine and olmesartan medoxomil as 5/20 mg or 10/20 mg or 5/40 mg or 10/40 mg and also contains the following inactive ingredients: anhydrous lactose, croscarmellose sodium, colloidal silicon dioxide, hypromellose, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, pregelatinized starch, polyethylene glycol, talc and titanium dioxide. Apart from this following inactive ingredients are also present. 5mg/40mg tablets: iron oxide yellow, iron oxide red, ferrosoferric oxide. 10mg/20mg tablets: iron oxide yellow, iron oxide red. 10mg/40mg tablets: iron oxide yellow, iron oxide red."
},
{
"NDCCode": "68382-930-10",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (68382-930-10) ",
"NDC11Code": "68382-0930-10",
"ProductNDC": "68382-930",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine And Olmesartan Medoxomil",
"NonProprietaryName": "Amlodipine And Olmesartan Medoxomil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180104",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207771",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL",
"StrengthNumber": "10; 40",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180104",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine and olmesartan medoxomil tablets are a combination of a dihydropyridine calcium channel blocker and an angiotensin II receptor blocker combination product indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1). Amlodipine and olmesartan medoxomil tablets may also be used as initial therapy in patients likely to need multiple antihypertensive agents to achieve their blood pressure goals (1).",
"Description": "Amlodipine and olmesartan medoxomil provided as a tablet for oral administration, is a combination of the calcium channel blocker (CCB) amlodipine besylate and the angiotensin II receptor blocker (ARB) olmesartan medoxomil. The amlodipine besylate component of amlodipine and olmesartan medoxomil is chemically described as 3-ethyl-5 methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5 pyridinedicarboxylate, monobenzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S. Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of amlodipine and olmesartan medoxomil is chemically described as 2,3 dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5 ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its molecular formula is C29H30N6O6. The structural formula for amlodipine besylate is. Amlodipine besylate USP is white or almost white powder, The molecular weights of amlodipine besylate is 567.05. Amlodipine besylate USP is freely soluble in methanol, sparingly soluble in anhydrous ethanol, slightly soluble in 2-propanol and in water. Olmesartan medoxomil, USP is a white or almost white crystalline powder with a molecular weight of 558.59. It is insoluble in water and sparingly soluble in methanol. Each amlodipine and olmesartan medoxomil tablet contains combination of amlodipine and olmesartan medoxomil as 5/20 mg or 10/20 mg or 5/40 mg or 10/40 mg and also contains the following inactive ingredients: anhydrous lactose, croscarmellose sodium, colloidal silicon dioxide, hypromellose, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, pregelatinized starch, polyethylene glycol, talc and titanium dioxide. Apart from this following inactive ingredients are also present. 5mg/40mg tablets: iron oxide yellow, iron oxide red, ferrosoferric oxide. 10mg/20mg tablets: iron oxide yellow, iron oxide red. 10mg/40mg tablets: iron oxide yellow, iron oxide red."
},
{
"NDCCode": "68382-930-16",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (68382-930-16) ",
"NDC11Code": "68382-0930-16",
"ProductNDC": "68382-930",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine And Olmesartan Medoxomil",
"NonProprietaryName": "Amlodipine And Olmesartan Medoxomil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180104",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207771",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL",
"StrengthNumber": "10; 40",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180104",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine and olmesartan medoxomil tablets are a combination of a dihydropyridine calcium channel blocker and an angiotensin II receptor blocker combination product indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1). Amlodipine and olmesartan medoxomil tablets may also be used as initial therapy in patients likely to need multiple antihypertensive agents to achieve their blood pressure goals (1).",
"Description": "Amlodipine and olmesartan medoxomil provided as a tablet for oral administration, is a combination of the calcium channel blocker (CCB) amlodipine besylate and the angiotensin II receptor blocker (ARB) olmesartan medoxomil. The amlodipine besylate component of amlodipine and olmesartan medoxomil is chemically described as 3-ethyl-5 methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5 pyridinedicarboxylate, monobenzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S. Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of amlodipine and olmesartan medoxomil is chemically described as 2,3 dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5 ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its molecular formula is C29H30N6O6. The structural formula for amlodipine besylate is. Amlodipine besylate USP is white or almost white powder, The molecular weights of amlodipine besylate is 567.05. Amlodipine besylate USP is freely soluble in methanol, sparingly soluble in anhydrous ethanol, slightly soluble in 2-propanol and in water. Olmesartan medoxomil, USP is a white or almost white crystalline powder with a molecular weight of 558.59. It is insoluble in water and sparingly soluble in methanol. Each amlodipine and olmesartan medoxomil tablet contains combination of amlodipine and olmesartan medoxomil as 5/20 mg or 10/20 mg or 5/40 mg or 10/40 mg and also contains the following inactive ingredients: anhydrous lactose, croscarmellose sodium, colloidal silicon dioxide, hypromellose, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, pregelatinized starch, polyethylene glycol, talc and titanium dioxide. Apart from this following inactive ingredients are also present. 5mg/40mg tablets: iron oxide yellow, iron oxide red, ferrosoferric oxide. 10mg/20mg tablets: iron oxide yellow, iron oxide red. 10mg/40mg tablets: iron oxide yellow, iron oxide red."
},
{
"NDCCode": "68382-930-77",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (68382-930-77) > 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-930-30) ",
"NDC11Code": "68382-0930-77",
"ProductNDC": "68382-930",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine And Olmesartan Medoxomil",
"NonProprietaryName": "Amlodipine And Olmesartan Medoxomil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180104",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207771",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL",
"StrengthNumber": "10; 40",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180104",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine and olmesartan medoxomil tablets are a combination of a dihydropyridine calcium channel blocker and an angiotensin II receptor blocker combination product indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1). Amlodipine and olmesartan medoxomil tablets may also be used as initial therapy in patients likely to need multiple antihypertensive agents to achieve their blood pressure goals (1).",
"Description": "Amlodipine and olmesartan medoxomil provided as a tablet for oral administration, is a combination of the calcium channel blocker (CCB) amlodipine besylate and the angiotensin II receptor blocker (ARB) olmesartan medoxomil. The amlodipine besylate component of amlodipine and olmesartan medoxomil is chemically described as 3-ethyl-5 methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5 pyridinedicarboxylate, monobenzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S. Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of amlodipine and olmesartan medoxomil is chemically described as 2,3 dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5 ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its molecular formula is C29H30N6O6. The structural formula for amlodipine besylate is. Amlodipine besylate USP is white or almost white powder, The molecular weights of amlodipine besylate is 567.05. Amlodipine besylate USP is freely soluble in methanol, sparingly soluble in anhydrous ethanol, slightly soluble in 2-propanol and in water. Olmesartan medoxomil, USP is a white or almost white crystalline powder with a molecular weight of 558.59. It is insoluble in water and sparingly soluble in methanol. Each amlodipine and olmesartan medoxomil tablet contains combination of amlodipine and olmesartan medoxomil as 5/20 mg or 10/20 mg or 5/40 mg or 10/40 mg and also contains the following inactive ingredients: anhydrous lactose, croscarmellose sodium, colloidal silicon dioxide, hypromellose, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, pregelatinized starch, polyethylene glycol, talc and titanium dioxide. Apart from this following inactive ingredients are also present. 5mg/40mg tablets: iron oxide yellow, iron oxide red, ferrosoferric oxide. 10mg/20mg tablets: iron oxide yellow, iron oxide red. 10mg/40mg tablets: iron oxide yellow, iron oxide red."
},
{
"NDCCode": "71101-930-01",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (71101-930-01) / 49.6 g in 1 BOTTLE, PLASTIC",
"NDC11Code": "71101-0930-01",
"ProductNDC": "71101-930",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Theracare 4% Lidocaine Cream",
"NonProprietaryName": "Lidocaine Hydrochloride",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210701",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Veridian Healthcare",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "g/100g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2024-05-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210701",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor pain."
},
{
"NDCCode": "71105-930-01",
"PackageDescription": "50 PACKET in 1 BOX (71105-930-01) / 1 mg in 1 PACKET",
"NDC11Code": "71105-0930-01",
"ProductNDC": "71105-930",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Redicare Cough Drops Cherry Flavored",
"NonProprietaryName": "Cherry Flavored Menthol Cough Drops",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20250225",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Redicare LLC",
"SubstanceName": "MENTHOL, UNSPECIFIED FORM",
"StrengthNumber": "7.6",
"StrengthUnit": "mg/100mg",
"Status": "Active",
"LastUpdate": "2025-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250225",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves these symptoms as may occur with colds or inhaled irritants: 1 Cough, 2 Sore Throat."
},
{
"NDCCode": "74439-003-03",
"PackageDescription": "930 g in 1 CANISTER (74439-003-03) ",
"NDC11Code": "74439-0003-03",
"ProductNDC": "74439-003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alcohol Wet Tissue",
"NonProprietaryName": "Wet Tissue",
"DosageFormName": "SWAB",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200413",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "SHANDONG PROVINCE RUNHE SANITARY MATERIALS CO.,LTD.",
"SubstanceName": "ALCOHOL; BENZALKONIUM CHLORIDE; CETYLPYRIDINIUM CHLORIDE",
"StrengthNumber": "75; .1; .05",
"StrengthUnit": "g/100g; g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200601",
"SamplePackage": "N"
},
{
"NDCCode": "74439-004-03",
"PackageDescription": "930 g in 1 CANISTER (74439-004-03) ",
"NDC11Code": "74439-0004-03",
"ProductNDC": "74439-004",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Disinfecting Wipes",
"NonProprietaryName": "Wet Wipes",
"DosageFormName": "SWAB",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200413",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "SHANDONG PROVINCE RUNHE SANITARY MATERIALS CO.,LTD.",
"SubstanceName": "BENZALKONIUM CHLORIDE; CETYLPYRIDINIUM CHLORIDE; ISOPROPYL ALCOHOL",
"StrengthNumber": ".1; .05; 75",
"StrengthUnit": "g/100g; g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200601",
"SamplePackage": "N"
},
{
"NDCCode": "74439-703-03",
"PackageDescription": "930 g in 1 CANISTER (74439-703-03) ",
"NDC11Code": "74439-0703-03",
"ProductNDC": "74439-703",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Disinfecting Wipes",
"NonProprietaryName": "Wet Wipes",
"DosageFormName": "SWAB",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200413",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "SHANDONG PROVINCE RUNHE SANITARY MATERIALS CO.,LTD.",
"SubstanceName": "ISOPROPYL ALCOHOL; DIDECYLDIMONIUM CHLORIDE; CHLORPHENESIN; BENZALKONIUM CHLORIDE; CETYLPYRIDINIUM CHLORIDE",
"StrengthNumber": "75; .1; .05; .1; .05",
"StrengthUnit": "g/100g; g/100g; g/100g; g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-07-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200601",
"SamplePackage": "N"
}
]
}
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<NDCList>
<NDC>
<NDCCode>68428-930-05</NDCCode>
<PackageDescription>150 PELLET in 1 VIAL, GLASS (68428-930-05)</PackageDescription>
<NDC11Code>68428-0930-05</NDC11Code>
<ProductNDC>68428-930</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cytisus Scoparius</ProprietaryName>
<NonProprietaryName>Cytisus Scoparius Flowering Top</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130523</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>CYTISUS SCOPARIUS FLOWERING TOP</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications. CYTISUS Profuse urination.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68428-930-03</NDCCode>
<PackageDescription>75 PELLET in 1 VIAL, GLASS (68428-930-03)</PackageDescription>
<NDC11Code>68428-0930-03</NDC11Code>
<ProductNDC>68428-930</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cytisus Scoparius</ProprietaryName>
<NonProprietaryName>Cytisus Scoparius Flowering Top</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130523</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>CYTISUS SCOPARIUS FLOWERING TOP</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications. CYTISUS Profuse urination.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68428-930-06</NDCCode>
<PackageDescription>1200 PELLET in 1 BOTTLE, GLASS (68428-930-06)</PackageDescription>
<NDC11Code>68428-0930-06</NDC11Code>
<ProductNDC>68428-930</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cytisus Scoparius</ProprietaryName>
<NonProprietaryName>Cytisus Scoparius Flowering Top</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130523</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>CYTISUS SCOPARIUS FLOWERING TOP</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications. CYTISUS Profuse urination.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68428-930-11</NDCCode>
<PackageDescription>300 PELLET in 1 BOTTLE, GLASS (68428-930-11)</PackageDescription>
<NDC11Code>68428-0930-11</NDC11Code>
<ProductNDC>68428-930</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cytisus Scoparius</ProprietaryName>
<NonProprietaryName>Cytisus Scoparius Flowering Top</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130523</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>CYTISUS SCOPARIUS FLOWERING TOP</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications. CYTISUS Profuse urination.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68428-930-12</NDCCode>
<PackageDescription>600 PELLET in 1 BOTTLE, GLASS (68428-930-12)</PackageDescription>
<NDC11Code>68428-0930-12</NDC11Code>
<ProductNDC>68428-930</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cytisus Scoparius</ProprietaryName>
<NonProprietaryName>Cytisus Scoparius Flowering Top</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130523</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>CYTISUS SCOPARIUS FLOWERING TOP</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications. CYTISUS Profuse urination.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>40032-930-05</NDCCode>
<PackageDescription>500 mL in 1 BOTTLE (40032-930-05)</PackageDescription>
<NDC11Code>40032-0930-05</NDC11Code>
<ProductNDC>40032-930</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName>
<NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150814</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204602</ApplicationNumber>
<LabelerName>Novel laboratories, Inc.</LabelerName>
<SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Attention Deficit Disorders, Narcolepsy. Attention Deficit Disorders (previously known as Minimal Brain Dysfunction in Children). Other terms being used to describe the behavioral syndrome below include: Hyperkinetic Child Syndrome, Minimal Brain Damage, Minimal Cerebral Dysfunction, Minor Cerebral Dysfunction. Methylphenidate Hydrochloride is indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. Special Diagnostic Considerations. Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources. Characteristics commonly reported include: chronic history of short attention span, distractibility, emotional lability, impulsivity, and moderate-to-severe hyperactivity; minor neurological signs and abnormal EEG. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of one or more of these characteristics. Drug treatment is not indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is generally necessary. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the child's symptoms.</IndicationAndUsage>
<Description>Methylphenidate HCl oral solution, is a mild central nervous system (CNS) stimulant, available as 5 mg/5 mL and 10 mg/5 mL oral solutions for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is. Methylphenidate hydrochloride USP is a white to off white powder. It is soluble in water, alcohol, and chloroform. Each mL of Methylphenidate Hydrochloride Oral Solution 5 mg/5 mL contains 1 mg of methylphenidate hydrochloride USP. Each mL of Methylphenidate Hydrochloride Oral Solution 10 mg/5 mL contains 2 mg of methylphenidate hydrochloride USP. In addition, Methylphenidate Hydrochloride Oral Solution also contains the following inactive ingredients: PEG 1450, glycerin, phosphoric acid, grape flavor, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>43386-930-05</NDCCode>
<PackageDescription>500 mL in 1 BOTTLE (43386-930-05) </PackageDescription>
<NDC11Code>43386-0930-05</NDC11Code>
<ProductNDC>43386-930</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName>
<NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204602</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2023-12-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methylphenidate hydrochloride oral solution is indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years of age and older, 2 Narcolepsy.</IndicationAndUsage>
<Description>Methylphenidate hydrochloride oral solution contains methylphenidate hydrochloride a CNS stimulant. It is available as an oral solution in 5 mg/5 mL and 10 mg/5 mL strengths for oral administration. Chemically, methylphenidate hydrochloride is (d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride and its structural formula is. Methylphenidate hydrochloride, USP is a white to off white powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Each mL of methylphenidate hydrochloride oral solution 5 mg/5 mL contains 1 mg of methylphenidate hydrochloride, USP. Each mL of methylphenidate hydrochloride oral solution 10 mg/5 mL contains 2 mg of methylphenidate hydrochloride USP. Methylphenidate hydrochloride oral solution also contains the following inactive ingredients: PEG 1450, glycerin, phosphoric acid grape flavor, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>49884-930-05</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (49884-930-05)</PackageDescription>
<NDC11Code>49884-0930-05</NDC11Code>
<ProductNDC>49884-930</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078381</ApplicationNumber>
<LabelerName>Par Pharmaceutical Inc.</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>58657-930-05</NDCCode>
<PackageDescription>5 BLISTER PACK in 1 CARTON (58657-930-05) / 10 TABLET in 1 BLISTER PACK (58657-930-10) </PackageDescription>
<NDC11Code>58657-0930-05</NDC11Code>
<ProductNDC>58657-930</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Baclofen</ProprietaryName>
<NonProprietaryName>Baclofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240615</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212378</ApplicationNumber>
<LabelerName>Method Pharmaceuticals LLC</LabelerName>
<SubstanceName>BACLOFEN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Baclofen tablets USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.</IndicationAndUsage>
<Description>Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid, and its structural formula is. Baclofen, USP is a white to off-white odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg or 10 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, lactose monohydrate, microcrystalline cellulose, zinc stearate.</Description>
</NDC>
<NDC>
<NDCCode>67877-930-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (67877-930-05) </PackageDescription>
<NDC11Code>67877-0930-05</NDC11Code>
<ProductNDC>67877-930</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250825</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213320</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin hydrochloride tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5 HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets contain 500 mg, 850 mg, or 1,000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients hypromellose, magnesium stearate, polyethylene glycol/macrogol, povidone, titanium dioxide and artificial blackberry flavor (maltodextrin, triacetin and artificial flavors). Metformin hydrochloride tablets dissolution USP Test-1 is used.</Description>
</NDC>
<NDC>
<NDCCode>68382-930-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (68382-930-05) </PackageDescription>
<NDC11Code>68382-0930-05</NDC11Code>
<ProductNDC>68382-930</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine And Olmesartan Medoxomil</ProprietaryName>
<NonProprietaryName>Amlodipine And Olmesartan Medoxomil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180104</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207771</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL</SubstanceName>
<StrengthNumber>10; 40</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine and olmesartan medoxomil tablets are a combination of a dihydropyridine calcium channel blocker and an angiotensin II receptor blocker combination product indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1). Amlodipine and olmesartan medoxomil tablets may also be used as initial therapy in patients likely to need multiple antihypertensive agents to achieve their blood pressure goals (1).</IndicationAndUsage>
<Description>Amlodipine and olmesartan medoxomil provided as a tablet for oral administration, is a combination of the calcium channel blocker (CCB) amlodipine besylate and the angiotensin II receptor blocker (ARB) olmesartan medoxomil. The amlodipine besylate component of amlodipine and olmesartan medoxomil is chemically described as 3-ethyl-5 methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5 pyridinedicarboxylate, monobenzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S. Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of amlodipine and olmesartan medoxomil is chemically described as 2,3 dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5 ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its molecular formula is C29H30N6O6. The structural formula for amlodipine besylate is. Amlodipine besylate USP is white or almost white powder, The molecular weights of amlodipine besylate is 567.05. Amlodipine besylate USP is freely soluble in methanol, sparingly soluble in anhydrous ethanol, slightly soluble in 2-propanol and in water. Olmesartan medoxomil, USP is a white or almost white crystalline powder with a molecular weight of 558.59. It is insoluble in water and sparingly soluble in methanol. Each amlodipine and olmesartan medoxomil tablet contains combination of amlodipine and olmesartan medoxomil as 5/20 mg or 10/20 mg or 5/40 mg or 10/40 mg and also contains the following inactive ingredients: anhydrous lactose, croscarmellose sodium, colloidal silicon dioxide, hypromellose, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, pregelatinized starch, polyethylene glycol, talc and titanium dioxide. Apart from this following inactive ingredients are also present. 5mg/40mg tablets: iron oxide yellow, iron oxide red, ferrosoferric oxide. 10mg/20mg tablets: iron oxide yellow, iron oxide red. 10mg/40mg tablets: iron oxide yellow, iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>84682-930-05</NDCCode>
<PackageDescription>100 g in 1 BOX (84682-930-05) </PackageDescription>
<NDC11Code>84682-0930-05</NDC11Code>
<ProductNDC>84682-930</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Trstay Neck Face Extea Nourishing Hydrating</ProprietaryName>
<NonProprietaryName>Trstay Neck Face Extea Nourishing Hydrating</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241107</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Yiwu Zhixin Trade Co Ltd</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84756-930-05</NDCCode>
<PackageDescription>100 g in 1 BOX (84756-930-05) </PackageDescription>
<NDC11Code>84756-0930-05</NDC11Code>
<ProductNDC>84756-930</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Retinol Collagen Moisturizer</ProprietaryName>
<NonProprietaryName>Retinol Collagen Moisturizer</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241213</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Yiwu Xinqian E Commerce Co Ltd</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>16714-930-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (16714-930-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>16714-0930-01</NDC11Code>
<ProductNDC>16714-930</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gemcitabine</ProprietaryName>
<NonProprietaryName>Gemcitabine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20181101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091365</ApplicationNumber>
<LabelerName>NorthStar Rx LLC</LabelerName>
<SubstanceName>GEMCITABINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gemcitabine for injection is a nucleoside metabolic inhibitor indicated: : 1 in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. (1.1) , 2 in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. (1.2) , 3 in combination with cisplatin, for the treatment of non-small cell lung cancer. (1.3) , 4 as a single agent for the treatment of pancreatic cancer. (1.4) .</IndicationAndUsage>
<Description>Gemcitabine is a nucleoside metabolic inhibitor. Gemcitabine hydrochloride is 2′-deoxy-2′,2′-difluorocytidine monohydrochloride (β-isomer) with the following structural formula. The empirical formula for gemcitabine hydrochloride is C9H11F2N3O4 HCl. It has a molecular weight of 299.66 g/mol. Gemcitabine HCl, USP is a white to off-white solid. It is soluble in water, slightly soluble in methanol, and practically insoluble in ethanol and polar organic solvents. Gemcitabine for injection, USP is a white to off-white, lyophilized powder and available as 200 mg and 1 g sterile single-dose vials for intravenous use only. Each 200 mg vial contains 200 mg gemcitabine hydrochloride (expressed as free base), 200 mg mannitol and 20.73 mg of sodium acetate trihydrate (equivalent to 12.5 mg of sodium acetate anhydrous). Each 1 g vial contains 1 g gemcitabine hydrochloride (expressed as free base), 1 g mannitol, and 103.5 mg of sodium acetate trihydrate (equivalent to 62.5 mg of sodium acetate anhydrous). Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment.</Description>
</NDC>
<NDC>
<NDCCode>42858-930-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42858-930-01) </PackageDescription>
<NDC11Code>42858-0930-01</NDC11Code>
<ProductNDC>42858-930</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate Extended-release</ProprietaryName>
<NonProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190822</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210651</ApplicationNumber>
<LabelerName>Rhodes Pharmaceuticals LLC</LabelerName>
<SubstanceName>DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>7.5; 7.5; 7.5; 7.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190822</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules, a CNS stimulant, is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older. (1). Limitations of Use. The use of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage. (5.5, 8.4).</IndicationAndUsage>
<Description>Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules contain equal amounts (by weight) of four salts: dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate. This results in a 3.1:1 mixture of dextro- to levo-amphetamine base equivalent. The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg strength extended-release capsules are for oral administration. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules are a once daily extended-release, single-entity amphetamine product. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules combine the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d, l-amphetamine aspartate monohydrate. The dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules are a dose proportional composition using a multi-layer fluid bed bead coating process, followed by encapsulation using hard gelatin capsules. The dosage utilizes a bead that is coated with an extended-release drug layer, that is then coated with an enteric polymer to control drug release, and finally coated with an immediate-release drug layer.</Description>
</NDC>
<NDC>
<NDCCode>43063-930-20</NDCCode>
<PackageDescription>20 CAPSULE in 1 BOTTLE, PLASTIC (43063-930-20) </PackageDescription>
<NDC11Code>43063-0930-20</NDC11Code>
<ProductNDC>43063-930</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Indomethacin</ProprietaryName>
<NonProprietaryName>Indomethacin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091276</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>INDOMETHACIN</SubstanceName>
<StrengthNumber>50</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>2026-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190109</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indomethacin capsules are indicated for: 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease, 2 Moderate to severe ankylosing spondylitis, 3 Moderate to severe osteoarthritis, 4 Acute painful shoulder (bursitis and/or tendinitis), 5 Acute gouty arthritis.</IndicationAndUsage>
<Description>Indomethacin Capsules, USP are nonsteroidal anti-inflammatory drugs, available as capsules containing 25 mg and 50 mg of indomethacin, USP, administered for oral use. The chemical name is 1-( p-chlorobenzoyl)-5-methoxy-2-methylindole-3-acetic acid. The molecular weight is 357.79 g/mol. Its molecular formula is C 19H 16ClNO 4, and it has the following chemical structure. Indomethacin, USP is a white to yellow crystalline powder. It is practically insoluble in water and sparingly soluble in alcohol, chloroform, and in ether. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The inactive ingredients in Indomethacin Capsules, USP 25 mg and 50 mg include: colloidal silicon dioxide, FD&C Blue No. 1, FD&C Yellow No. 5, gelatin, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate and titanium dioxide. The imprinting ink contains: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>51407-930-11</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (51407-930-11) / 1 SYRINGE in 1 BLISTER PACK / 1 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>51407-0930-11</NDC11Code>
<ProductNDC>51407-930</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Imuldosa</ProprietaryName>
<NonProprietaryName>Ustekinumab-srlf</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20241010</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761364</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>USTEKINUMAB-SRLF</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250618</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>IMULDOSA is a human interleukin-12 and -23 antagonist indicated for the treatment of: Adult patients with: moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. ( 1.1) active psoriatic arthritis (PsA). ( 1.2) moderately to severely active Crohn’s disease (CD). ( 1.3) moderately to severely active ulcerative colitis. ( 1.4) Pediatric patients 6 years and older with: moderate to severe plaque psoriasis (PsO), who are candidates for phototherapy or systemic therapy. ( 1.1) active psoriatic arthritis (PsA). ( 1.2).</IndicationAndUsage>
<Description>Ustekinumab-srlf, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-srlf is produced in a murine cell line (Sp2/0). The manufacturing process contains steps for the clearance of viruses. Ustekinumab-srlf is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. IMULDOSA (ustekinumab-srlf) injection is a sterile, preservative-free, clear to slightly opalescent and colorless to slightly yellow solution with pH of 5.7- 6.3. IMULDOSA for Subcutaneous Use Available as 45 mg of ustekinumab-srlf in 0.5 mL and 90 mg of ustekinumab-srlf in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 29-gauge fixed ½ inch needle. The syringe is fitted with a passive needle guard and a needle cover that does not contains latex. Each 0.5 mL prefilled syringe delivers 45 mg ustekinumab-srlf, histidine (2.23 mg) and L-histidine hydrochloride monohydrate (4.14 mg), polysorbate 80 (0.02 mg), and sucrose (25.9 mg). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-srlf, histidine (4.46 mg) and L-histidine hydrochloride monohydrate (8.28 mg), polysorbate 80 (0.04 mg), and sucrose (51.8 mg). IMULDOSA for Intravenous Infusion Available as 130 mg of ustekinumab-srlf in 26 mL, supplied as a single-dose 30 mL Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-srlf, edetate disodium (0.52 mg), histidine (20 mg), L-histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), Polysorbate 80 (10.4 mg) and sucrose (2,210 mg).</Description>
</NDC>
<NDC>
<NDCCode>55319-930-03</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (55319-930-03) / 118 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>55319-0930-03</NDC11Code>
<ProductNDC>55319-930</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Family Wellness Childrens Pain Reliever 574</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240418</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Family Dollar Services, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240418</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily: : 1 reduces fever , 2 relieves minor aches and pains due to: the common coldsore throatflutoothacheheadache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58657-930-01</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (58657-930-01) / 10 TABLET in 1 BLISTER PACK (58657-930-10) </PackageDescription>
<NDC11Code>58657-0930-01</NDC11Code>
<ProductNDC>58657-930</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Baclofen</ProprietaryName>
<NonProprietaryName>Baclofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240615</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212378</ApplicationNumber>
<LabelerName>Method Pharmaceuticals LLC</LabelerName>
<SubstanceName>BACLOFEN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Baclofen tablets USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.</IndicationAndUsage>
<Description>Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid, and its structural formula is. Baclofen, USP is a white to off-white odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg or 10 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, lactose monohydrate, microcrystalline cellulose, zinc stearate.</Description>
</NDC>
<NDC>
<NDCCode>66326-213-05</NDCCode>
<PackageDescription>75 kg in 1 DRUM (66326-213-05) </PackageDescription>
<NDC11Code>66326-0213-05</NDC11Code>
<ProductNDC>66326-213</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>GRANULE</DosageFormName>
<StartMarketingDate>20200103</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Sri Krishna Pharmaceuticals Ltd. Unit 1</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>930</StrengthNumber>
<StrengthUnit>g/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>03-JAN-20</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>68382-930-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (68382-930-01) </PackageDescription>
<NDC11Code>68382-0930-01</NDC11Code>
<ProductNDC>68382-930</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine And Olmesartan Medoxomil</ProprietaryName>
<NonProprietaryName>Amlodipine And Olmesartan Medoxomil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180104</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207771</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL</SubstanceName>
<StrengthNumber>10; 40</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine and olmesartan medoxomil tablets are a combination of a dihydropyridine calcium channel blocker and an angiotensin II receptor blocker combination product indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1). Amlodipine and olmesartan medoxomil tablets may also be used as initial therapy in patients likely to need multiple antihypertensive agents to achieve their blood pressure goals (1).</IndicationAndUsage>
<Description>Amlodipine and olmesartan medoxomil provided as a tablet for oral administration, is a combination of the calcium channel blocker (CCB) amlodipine besylate and the angiotensin II receptor blocker (ARB) olmesartan medoxomil. The amlodipine besylate component of amlodipine and olmesartan medoxomil is chemically described as 3-ethyl-5 methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5 pyridinedicarboxylate, monobenzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S. Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of amlodipine and olmesartan medoxomil is chemically described as 2,3 dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5 ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its molecular formula is C29H30N6O6. The structural formula for amlodipine besylate is. Amlodipine besylate USP is white or almost white powder, The molecular weights of amlodipine besylate is 567.05. Amlodipine besylate USP is freely soluble in methanol, sparingly soluble in anhydrous ethanol, slightly soluble in 2-propanol and in water. Olmesartan medoxomil, USP is a white or almost white crystalline powder with a molecular weight of 558.59. It is insoluble in water and sparingly soluble in methanol. Each amlodipine and olmesartan medoxomil tablet contains combination of amlodipine and olmesartan medoxomil as 5/20 mg or 10/20 mg or 5/40 mg or 10/40 mg and also contains the following inactive ingredients: anhydrous lactose, croscarmellose sodium, colloidal silicon dioxide, hypromellose, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, pregelatinized starch, polyethylene glycol, talc and titanium dioxide. Apart from this following inactive ingredients are also present. 5mg/40mg tablets: iron oxide yellow, iron oxide red, ferrosoferric oxide. 10mg/20mg tablets: iron oxide yellow, iron oxide red. 10mg/40mg tablets: iron oxide yellow, iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>68382-930-06</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (68382-930-06) </PackageDescription>
<NDC11Code>68382-0930-06</NDC11Code>
<ProductNDC>68382-930</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine And Olmesartan Medoxomil</ProprietaryName>
<NonProprietaryName>Amlodipine And Olmesartan Medoxomil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180104</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207771</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL</SubstanceName>
<StrengthNumber>10; 40</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine and olmesartan medoxomil tablets are a combination of a dihydropyridine calcium channel blocker and an angiotensin II receptor blocker combination product indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1). Amlodipine and olmesartan medoxomil tablets may also be used as initial therapy in patients likely to need multiple antihypertensive agents to achieve their blood pressure goals (1).</IndicationAndUsage>
<Description>Amlodipine and olmesartan medoxomil provided as a tablet for oral administration, is a combination of the calcium channel blocker (CCB) amlodipine besylate and the angiotensin II receptor blocker (ARB) olmesartan medoxomil. The amlodipine besylate component of amlodipine and olmesartan medoxomil is chemically described as 3-ethyl-5 methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5 pyridinedicarboxylate, monobenzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S. Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of amlodipine and olmesartan medoxomil is chemically described as 2,3 dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5 ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its molecular formula is C29H30N6O6. The structural formula for amlodipine besylate is. Amlodipine besylate USP is white or almost white powder, The molecular weights of amlodipine besylate is 567.05. Amlodipine besylate USP is freely soluble in methanol, sparingly soluble in anhydrous ethanol, slightly soluble in 2-propanol and in water. Olmesartan medoxomil, USP is a white or almost white crystalline powder with a molecular weight of 558.59. It is insoluble in water and sparingly soluble in methanol. Each amlodipine and olmesartan medoxomil tablet contains combination of amlodipine and olmesartan medoxomil as 5/20 mg or 10/20 mg or 5/40 mg or 10/40 mg and also contains the following inactive ingredients: anhydrous lactose, croscarmellose sodium, colloidal silicon dioxide, hypromellose, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, pregelatinized starch, polyethylene glycol, talc and titanium dioxide. Apart from this following inactive ingredients are also present. 5mg/40mg tablets: iron oxide yellow, iron oxide red, ferrosoferric oxide. 10mg/20mg tablets: iron oxide yellow, iron oxide red. 10mg/40mg tablets: iron oxide yellow, iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>68382-930-10</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (68382-930-10) </PackageDescription>
<NDC11Code>68382-0930-10</NDC11Code>
<ProductNDC>68382-930</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine And Olmesartan Medoxomil</ProprietaryName>
<NonProprietaryName>Amlodipine And Olmesartan Medoxomil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180104</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207771</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL</SubstanceName>
<StrengthNumber>10; 40</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine and olmesartan medoxomil tablets are a combination of a dihydropyridine calcium channel blocker and an angiotensin II receptor blocker combination product indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1). Amlodipine and olmesartan medoxomil tablets may also be used as initial therapy in patients likely to need multiple antihypertensive agents to achieve their blood pressure goals (1).</IndicationAndUsage>
<Description>Amlodipine and olmesartan medoxomil provided as a tablet for oral administration, is a combination of the calcium channel blocker (CCB) amlodipine besylate and the angiotensin II receptor blocker (ARB) olmesartan medoxomil. The amlodipine besylate component of amlodipine and olmesartan medoxomil is chemically described as 3-ethyl-5 methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5 pyridinedicarboxylate, monobenzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S. Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of amlodipine and olmesartan medoxomil is chemically described as 2,3 dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5 ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its molecular formula is C29H30N6O6. The structural formula for amlodipine besylate is. Amlodipine besylate USP is white or almost white powder, The molecular weights of amlodipine besylate is 567.05. Amlodipine besylate USP is freely soluble in methanol, sparingly soluble in anhydrous ethanol, slightly soluble in 2-propanol and in water. Olmesartan medoxomil, USP is a white or almost white crystalline powder with a molecular weight of 558.59. It is insoluble in water and sparingly soluble in methanol. Each amlodipine and olmesartan medoxomil tablet contains combination of amlodipine and olmesartan medoxomil as 5/20 mg or 10/20 mg or 5/40 mg or 10/40 mg and also contains the following inactive ingredients: anhydrous lactose, croscarmellose sodium, colloidal silicon dioxide, hypromellose, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, pregelatinized starch, polyethylene glycol, talc and titanium dioxide. Apart from this following inactive ingredients are also present. 5mg/40mg tablets: iron oxide yellow, iron oxide red, ferrosoferric oxide. 10mg/20mg tablets: iron oxide yellow, iron oxide red. 10mg/40mg tablets: iron oxide yellow, iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>68382-930-16</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (68382-930-16) </PackageDescription>
<NDC11Code>68382-0930-16</NDC11Code>
<ProductNDC>68382-930</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine And Olmesartan Medoxomil</ProprietaryName>
<NonProprietaryName>Amlodipine And Olmesartan Medoxomil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180104</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207771</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL</SubstanceName>
<StrengthNumber>10; 40</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine and olmesartan medoxomil tablets are a combination of a dihydropyridine calcium channel blocker and an angiotensin II receptor blocker combination product indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1). Amlodipine and olmesartan medoxomil tablets may also be used as initial therapy in patients likely to need multiple antihypertensive agents to achieve their blood pressure goals (1).</IndicationAndUsage>
<Description>Amlodipine and olmesartan medoxomil provided as a tablet for oral administration, is a combination of the calcium channel blocker (CCB) amlodipine besylate and the angiotensin II receptor blocker (ARB) olmesartan medoxomil. The amlodipine besylate component of amlodipine and olmesartan medoxomil is chemically described as 3-ethyl-5 methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5 pyridinedicarboxylate, monobenzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S. Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of amlodipine and olmesartan medoxomil is chemically described as 2,3 dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5 ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its molecular formula is C29H30N6O6. The structural formula for amlodipine besylate is. Amlodipine besylate USP is white or almost white powder, The molecular weights of amlodipine besylate is 567.05. Amlodipine besylate USP is freely soluble in methanol, sparingly soluble in anhydrous ethanol, slightly soluble in 2-propanol and in water. Olmesartan medoxomil, USP is a white or almost white crystalline powder with a molecular weight of 558.59. It is insoluble in water and sparingly soluble in methanol. Each amlodipine and olmesartan medoxomil tablet contains combination of amlodipine and olmesartan medoxomil as 5/20 mg or 10/20 mg or 5/40 mg or 10/40 mg and also contains the following inactive ingredients: anhydrous lactose, croscarmellose sodium, colloidal silicon dioxide, hypromellose, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, pregelatinized starch, polyethylene glycol, talc and titanium dioxide. Apart from this following inactive ingredients are also present. 5mg/40mg tablets: iron oxide yellow, iron oxide red, ferrosoferric oxide. 10mg/20mg tablets: iron oxide yellow, iron oxide red. 10mg/40mg tablets: iron oxide yellow, iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>68382-930-77</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (68382-930-77) > 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-930-30) </PackageDescription>
<NDC11Code>68382-0930-77</NDC11Code>
<ProductNDC>68382-930</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine And Olmesartan Medoxomil</ProprietaryName>
<NonProprietaryName>Amlodipine And Olmesartan Medoxomil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180104</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207771</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL</SubstanceName>
<StrengthNumber>10; 40</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine and olmesartan medoxomil tablets are a combination of a dihydropyridine calcium channel blocker and an angiotensin II receptor blocker combination product indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1). Amlodipine and olmesartan medoxomil tablets may also be used as initial therapy in patients likely to need multiple antihypertensive agents to achieve their blood pressure goals (1).</IndicationAndUsage>
<Description>Amlodipine and olmesartan medoxomil provided as a tablet for oral administration, is a combination of the calcium channel blocker (CCB) amlodipine besylate and the angiotensin II receptor blocker (ARB) olmesartan medoxomil. The amlodipine besylate component of amlodipine and olmesartan medoxomil is chemically described as 3-ethyl-5 methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5 pyridinedicarboxylate, monobenzenesulphonate. Its molecular formula is C20H25ClN2O5C6H6O3S. Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of amlodipine and olmesartan medoxomil is chemically described as 2,3 dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5 ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its molecular formula is C29H30N6O6. The structural formula for amlodipine besylate is. Amlodipine besylate USP is white or almost white powder, The molecular weights of amlodipine besylate is 567.05. Amlodipine besylate USP is freely soluble in methanol, sparingly soluble in anhydrous ethanol, slightly soluble in 2-propanol and in water. Olmesartan medoxomil, USP is a white or almost white crystalline powder with a molecular weight of 558.59. It is insoluble in water and sparingly soluble in methanol. Each amlodipine and olmesartan medoxomil tablet contains combination of amlodipine and olmesartan medoxomil as 5/20 mg or 10/20 mg or 5/40 mg or 10/40 mg and also contains the following inactive ingredients: anhydrous lactose, croscarmellose sodium, colloidal silicon dioxide, hypromellose, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, pregelatinized starch, polyethylene glycol, talc and titanium dioxide. Apart from this following inactive ingredients are also present. 5mg/40mg tablets: iron oxide yellow, iron oxide red, ferrosoferric oxide. 10mg/20mg tablets: iron oxide yellow, iron oxide red. 10mg/40mg tablets: iron oxide yellow, iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>71101-930-01</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (71101-930-01) / 49.6 g in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>71101-0930-01</NDC11Code>
<ProductNDC>71101-930</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Theracare 4% Lidocaine Cream</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210701</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Veridian Healthcare</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71105-930-01</NDCCode>
<PackageDescription>50 PACKET in 1 BOX (71105-930-01) / 1 mg in 1 PACKET</PackageDescription>
<NDC11Code>71105-0930-01</NDC11Code>
<ProductNDC>71105-930</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Redicare Cough Drops Cherry Flavored</ProprietaryName>
<NonProprietaryName>Cherry Flavored Menthol Cough Drops</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250225</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Redicare LLC</LabelerName>
<SubstanceName>MENTHOL, UNSPECIFIED FORM</SubstanceName>
<StrengthNumber>7.6</StrengthNumber>
<StrengthUnit>mg/100mg</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250225</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves these symptoms as may occur with colds or inhaled irritants: 1 Cough, 2 Sore Throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>74439-003-03</NDCCode>
<PackageDescription>930 g in 1 CANISTER (74439-003-03) </PackageDescription>
<NDC11Code>74439-0003-03</NDC11Code>
<ProductNDC>74439-003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alcohol Wet Tissue</ProprietaryName>
<NonProprietaryName>Wet Tissue</NonProprietaryName>
<DosageFormName>SWAB</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200413</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>SHANDONG PROVINCE RUNHE SANITARY MATERIALS CO.,LTD.</LabelerName>
<SubstanceName>ALCOHOL; BENZALKONIUM CHLORIDE; CETYLPYRIDINIUM CHLORIDE</SubstanceName>
<StrengthNumber>75; .1; .05</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>74439-004-03</NDCCode>
<PackageDescription>930 g in 1 CANISTER (74439-004-03) </PackageDescription>
<NDC11Code>74439-0004-03</NDC11Code>
<ProductNDC>74439-004</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Disinfecting Wipes</ProprietaryName>
<NonProprietaryName>Wet Wipes</NonProprietaryName>
<DosageFormName>SWAB</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200413</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>SHANDONG PROVINCE RUNHE SANITARY MATERIALS CO.,LTD.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE; CETYLPYRIDINIUM CHLORIDE; ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>.1; .05; 75</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>74439-703-03</NDCCode>
<PackageDescription>930 g in 1 CANISTER (74439-703-03) </PackageDescription>
<NDC11Code>74439-0703-03</NDC11Code>
<ProductNDC>74439-703</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Disinfecting Wipes</ProprietaryName>
<NonProprietaryName>Wet Wipes</NonProprietaryName>
<DosageFormName>SWAB</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200413</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>SHANDONG PROVINCE RUNHE SANITARY MATERIALS CO.,LTD.</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL; DIDECYLDIMONIUM CHLORIDE; CHLORPHENESIN; BENZALKONIUM CHLORIDE; CETYLPYRIDINIUM CHLORIDE</SubstanceName>
<StrengthNumber>75; .1; .05; .1; .05</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g; g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-07-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>