{
"NDC": [
{
"NDCCode": "62135-683-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (62135-683-10) ",
"NDC11Code": "62135-0683-10",
"ProductNDC": "62135-683",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075972",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "850",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220406",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride tablets is 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, USP is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5 HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of Metformin Hydrochloride is 6.68. Metformin hydrochloride tablets, USP contain 500 mg, 625 mg, 750 mg, 850 mg, or 1000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 487.41 mg, 584.90 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients microcrystalline cellulose, copovidone, hydroxypropyl methylcellulose, crospovidone, talc, magnesium stearate, titanium dioxide, polyethylene glycol, and polysorbate."
},
{
"NDCCode": "62135-683-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (62135-683-05) ",
"NDC11Code": "62135-0683-05",
"ProductNDC": "62135-683",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075972",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "850",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220406",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride tablets is 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, USP is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5 HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of Metformin Hydrochloride is 6.68. Metformin hydrochloride tablets, USP contain 500 mg, 625 mg, 750 mg, 850 mg, or 1000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 487.41 mg, 584.90 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients microcrystalline cellulose, copovidone, hydroxypropyl methylcellulose, crospovidone, talc, magnesium stearate, titanium dioxide, polyethylene glycol, and polysorbate."
},
{
"NDCCode": "62135-683-18",
"PackageDescription": "180 TABLET in 1 BOTTLE (62135-683-18) ",
"NDC11Code": "62135-0683-18",
"ProductNDC": "62135-683",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075972",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "850",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220406",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride tablets is 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, USP is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5 HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of Metformin Hydrochloride is 6.68. Metformin hydrochloride tablets, USP contain 500 mg, 625 mg, 750 mg, 850 mg, or 1000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 487.41 mg, 584.90 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients microcrystalline cellulose, copovidone, hydroxypropyl methylcellulose, crospovidone, talc, magnesium stearate, titanium dioxide, polyethylene glycol, and polysorbate."
},
{
"NDCCode": "62135-683-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (62135-683-30) ",
"NDC11Code": "62135-0683-30",
"ProductNDC": "62135-683",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075972",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "850",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220406",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride tablets is 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, USP is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5 HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of Metformin Hydrochloride is 6.68. Metformin hydrochloride tablets, USP contain 500 mg, 625 mg, 750 mg, 850 mg, or 1000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 487.41 mg, 584.90 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients microcrystalline cellulose, copovidone, hydroxypropyl methylcellulose, crospovidone, talc, magnesium stearate, titanium dioxide, polyethylene glycol, and polysorbate."
},
{
"NDCCode": "62135-683-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (62135-683-90) ",
"NDC11Code": "62135-0683-90",
"ProductNDC": "62135-683",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075972",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "850",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220406",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride tablets is 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, USP is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5 HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of Metformin Hydrochloride is 6.68. Metformin hydrochloride tablets, USP contain 500 mg, 625 mg, 750 mg, 850 mg, or 1000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 487.41 mg, 584.90 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients microcrystalline cellulose, copovidone, hydroxypropyl methylcellulose, crospovidone, talc, magnesium stearate, titanium dioxide, polyethylene glycol, and polysorbate."
},
{
"NDCCode": "13811-683-10",
"PackageDescription": "100 TABLET in 1 BOTTLE (13811-683-10)",
"NDC11Code": "13811-0683-10",
"ProductNDC": "13811-683",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aripiprazole",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150428",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202101",
"LabelerName": "Trigen Laboratories, LLC",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-10-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "25021-683-10",
"PackageDescription": "10 VIAL in 1 CARTON (25021-683-10) / 10 mL in 1 VIAL",
"NDC11Code": "25021-0683-10",
"ProductNDC": "25021-683",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketamine Hydrochloride",
"NonProprietaryName": "Ketamine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20230715",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216809",
"LabelerName": "Sagent Pharmaceuticals",
"SubstanceName": "KETAMINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "General Anesthesia [PE], General Anesthetic [EPC]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2023-07-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230715",
"SamplePackage": "N",
"IndicationAndUsage": "Ketamine hydrochloride injection is indicated: : 1 as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation. , 2 for the induction of anesthesia prior to the administration of other general anesthetic agents. , 3 as a supplement to other anesthetic agents. .",
"Description": "Ketamine hydrochloride injection, USP for intravenous or intramuscular use, contains ketamine, a nonbarbiturate general anesthetic. Ketamine hydrochloride, USP is a white or almost white, crystalline powder and has a molecular formula of C13H16ClNOHCl and a molecular weight of 274.19. The chemical name for ketamine hydrochloride is 2-(2-chlorophenyl)-2-(methylamino) cyclohexan-1-one hydrochloride. The chemical structure of ketamine hydrochloride is:. It is formulated as a slightly acidic (pH 3.5 to 5.5) sterile solution for intravenous or intramuscular injection. Each milliliter (mL) of the multiple-dose vials contain either 10 mg ketamine base (equivalent to 11.53 mg ketamine hydrochloride), 50 mg ketamine base (equivalent to 57.67 mg ketamine hydrochloride) or 100 mg ketamine base (equivalent to 115.33 mg ketamine hydrochloride) and not more than 0.10 mg/mL benzethonium chloride added as a preservative in water for injection. The 10 mg/mL solution has been made isotonic with 6.60 mg sodium chloride."
},
{
"NDCCode": "35000-683-10",
"PackageDescription": "473 mL in 1 BOTTLE (35000-683-10) ",
"NDC11Code": "35000-0683-10",
"ProductNDC": "35000-683",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hello Peace Out Plaque",
"ProprietaryNameSuffix": "Peace Out, Plaque Antigingivitis",
"NonProprietaryName": "Cetylpyridinium Chloride",
"DosageFormName": "MOUTHWASH",
"RouteName": "DENTAL",
"StartMarketingDate": "20230701",
"EndMarketingDate": "20271230",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Colgate-Palmolive Company",
"SubstanceName": "CETYLPYRIDINIUM CHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/20mL",
"Status": "Active",
"LastUpdate": "2025-11-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230701",
"EndMarketingDatePackage": "20271230",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent and reduce plaque and gingivitis. helps control plaque bacteria that contribute to the development of gingivitis, an early form of gum disease, and bleeding gums."
},
{
"NDCCode": "35356-683-10",
"PackageDescription": "10 TABLET in 1 BOTTLE (35356-683-10)",
"NDC11Code": "35356-0683-10",
"ProductNDC": "35356-683",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen",
"NonProprietaryName": "Naproxen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078250",
"LabelerName": "Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC",
"SubstanceName": "NAPROXEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-03-26",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "46708-683-10",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (46708-683-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "46708-0683-10",
"ProductNDC": "46708-683",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rivaroxaban",
"NonProprietaryName": "Rivaroxaban",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210301",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "RIVAROXABAN",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250514",
"SamplePackage": "N",
"IndicationAndUsage": "Rivaroxaban tablet is a factor Xa inhibitor indicated: to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation (1.1) for treatment of deep vein thrombosis (DVT) (1.2) for treatment of pulmonary embolism (PE) (1.3) for reduction in the risk of recurrence of DVT or PE (1.4) for prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery (1.5) for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients (1.6) to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) (1.7) to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD (1.8) for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years (1.9). for thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure (1.10).",
"Description": "Rivaroxaban, USP, a factor Xa (FXa) inhibitor, is the active ingredient in rivaroxaban tablets, USP with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban, USP is C19H18ClN3O5S and the molecular weight is 435.88. The structural formula is. Rivaroxaban, USP is a pure (S)-enantiomer. It is an white to yellowish powder. Rivaroxaban, USP is soluble in dimethyl sulfoxide, practically insoluble to very slightly soluble in acetone and water. Each rivaroxaban tablet, USP contains 2.5 mg, 10 mg, 15 mg or 20 mg of rivaroxaban, USP. The inactive ingredients of rivaroxaban tablets, USP are: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. Additionally, the proprietary film coating mixture used for rivaroxaban 2.5 mg tablet is Opadry® Yellow containing D&C yellow #10 aluminium lake, hypromellose, iron oxide red, iron oxide yellow, polyethylene glycol 6000, titanium dioxide, and for rivaroxaban 10 mg tablet is Opadry® Pink containing hypromellose, iron oxide red, polyethylene glycol 6000, talc, titanium dioxide, and for rivaroxaban 15 mg tablet and 20 mg tablet is Opadry® Brown containing hypromellose, iron oxide black, iron oxide red, polyethylene glycol 8000, and titanium dioxide. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "50844-683-10",
"PackageDescription": "3 BOTTLE in 1 CARTON (50844-683-10) > 36 TABLET, CHEWABLE in 1 BOTTLE",
"NDC11Code": "50844-0683-10",
"ProductNDC": "50844-683",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "St. Joseph Chewable Low Dose Aspirin",
"NonProprietaryName": "Aspirin",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20120305",
"MarketingCategoryName": "OTC MONOGRAPH DRUG PRODUCT MANUFACTURED UNDER CONTRACT",
"LabelerName": "L.N.K. International, Inc.",
"SubstanceName": "ASPIRIN",
"StrengthNumber": "81",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "51407-683-10",
"PackageDescription": "36 BOTTLE in 1 BOX (51407-683-10) / 1000 TABLET in 1 BOTTLE",
"NDC11Code": "51407-0683-10",
"ProductNDC": "51407-683",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Famotidine",
"NonProprietaryName": "Famotidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20010416",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075805",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "FAMOTIDINE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230308",
"SamplePackage": "N",
"IndicationAndUsage": "Famotidine tablets are indicated in adult and pediatric patients 40 kg and above for the treatment of. active duodenal ulcer (DU). active gastric ulcer(GU). symptomatic non-erosive gastroesophageal reflux disease (GERD). erosive esophagitis due to GERD, diagnosed by biopsy. Famotidine tablets are indicated in adults for the: treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison Syndrome, multiple endocrine neoplasias). reduction of the risk of duodenal ulcer recurrence.",
"Description": "The active ingredient in Famotidine tablets is a histamine-2 (H2) receptor antagonist. Famotidine is N’-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The empirical formula of famotidine is C 8H 15N 7O 2S 3and its molecular weight is 337.43. Its structural formula is:. Each Famotidine tablet for oral administration contains either 20 mg or 40 mg of famotidine and the following inactive ingredients: hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch (modified corn starch), sodium starch glycolate, talc, titanium dioxide and triacetin. Famotidine is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol."
},
{
"NDCCode": "51991-683-10",
"PackageDescription": "1000 TABLET, DELAYED RELEASE in 1 BOTTLE (51991-683-10) ",
"NDC11Code": "51991-0683-10",
"ProductNDC": "51991-683",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rabeprazole Sodium",
"NonProprietaryName": "Rabeprazole Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170601",
"EndMarketingDate": "20200228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204237",
"LabelerName": "Breckenridge Pharmaceutical, Inc.",
"SubstanceName": "RABEPRAZOLE SODIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-02-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170601",
"EndMarketingDatePackage": "20200228",
"SamplePackage": "N"
},
{
"NDCCode": "57664-683-57",
"PackageDescription": "10 BAG in 1 BOX (57664-683-57) / 300 mL in 1 BAG (57664-683-31) ",
"NDC11Code": "57664-0683-57",
"ProductNDC": "57664-683",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Linezolid",
"NonProprietaryName": "Linezolid",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20170201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207354",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "LINEZOLID",
"StrengthNumber": "600",
"StrengthUnit": "mg/300mL",
"Pharm_Classes": "Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]",
"Status": "Active",
"LastUpdate": "2026-09-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170201",
"SamplePackage": "N",
"IndicationAndUsage": "Linezolid injection is an oxazolidinone-class antibacterial indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia (1.1); Community-acquired pneumonia (1.2); Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis (1.3); Uncomplicated skin and skin structure infections (1.4); Vancomycin-resistant Enterococcus faecium infections. (1.5). Limitations of Use (1.6) : 1 Linezolid injection is not indicated for the treatment of Gram-negative infections., 2 The safety and efficacy of linezolid injection formulations given for longer than 28 days have not been evaluated in controlled clinical trials.",
"Description": "Linezolid injection contains linezolid, which is a synthetic antibacterial agent of the oxazolidinone class. The chemical name for linezolid is (S)-N-[[3-[3-Fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl] methyl]-acetamide. The empirical formula is C16H20FN3O4. Its molecular weight is 337.35, and its chemical structure is represented below. Linezolid injection is supplied as a ready-to-use sterile isotonic solution for intravenous infusion. Each mL contains 2 mg of linezolid. Inactive ingredients are dextrose monohydrate 50.24 mg/mL in an aqueous vehicle for intravenous administration, sodium citrate dihydrate 1.64 mg/mL, and citric acid anhydrous 0.85 mg/mL. Sodium hydroxide NF and/or hydrochloric acid NF are used to adjust the pH. The sodium (Na+) content is 0.38 mg/mL (5 mEq/300 mL bag and 1.7 mEq/100 mL bag)."
},
{
"NDCCode": "57896-683-10",
"PackageDescription": "1000 TABLET, COATED in 1 BOTTLE (57896-683-10) ",
"NDC11Code": "57896-0683-10",
"ProductNDC": "57896-683",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Geri-dryl Allergy Relief",
"NonProprietaryName": "Diphenhydramine Hcl",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200401",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Geri-Care Pharmaceutical Corp",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200401",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever and other upper respiratory allergies:. runny nose."
},
{
"NDCCode": "62332-683-10",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (62332-683-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "62332-0683-10",
"ProductNDC": "62332-683",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rivaroxaban",
"NonProprietaryName": "Rivaroxaban",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210301",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "RIVAROXABAN",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250514",
"SamplePackage": "N",
"IndicationAndUsage": "Rivaroxaban tablet is a factor Xa inhibitor indicated: to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation (1.1) for treatment of deep vein thrombosis (DVT) (1.2) for treatment of pulmonary embolism (PE) (1.3) for reduction in the risk of recurrence of DVT or PE (1.4) for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery (1.5) for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients (1.6) to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) (1.7) to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD (1.8) for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years (1.9). for thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure (1.10).",
"Description": "Rivaroxaban, USP, a factor Xa (FXa) inhibitor, is the active ingredient in rivaroxaban tablets, USP with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban, USP is C19H18ClN3O5S and the molecular weight is 435.88. The structural formula is. Rivaroxaban, USP is a pure (S)-enantiomer. It is an white to yellowish powder. Rivaroxaban, USP is soluble in dimethyl sulfoxide, practically insoluble to very slightly soluble in acetone and water. Each rivaroxaban tablet, USP contains 2.5 mg, 10 mg, 15 mg or 20 mg of rivaroxaban, USP. The inactive ingredients of rivaroxaban tablets, USP are: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. Additionally, the proprietary film coating mixture used for rivaroxaban 2.5 mg tablet is Opadry® Yellow containing D&C yellow #10 aluminium lake, hypromellose, iron oxide red, iron oxide yellow, polyethylene glycol 6000, titanium dioxide, and for rivaroxaban 10 mg tablet is Opadry® Pink containing hypromellose, iron oxide red, polyethylene glycol 6000, talc, titanium dioxide, and for rivaroxaban 15 mg tablet and 20 mg tablet is Opadry® Brown containing hypromellose, iron oxide black, iron oxide red, polyethylene glycol 8000, and titanium dioxide. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "63323-683-10",
"PackageDescription": "10 BAG in 1 CARTON (63323-683-10) / 1000 mL in 1 BAG (63323-683-01) ",
"NDC11Code": "63323-0683-10",
"ProductNDC": "63323-683",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride In Sodium Chloride",
"NonProprietaryName": "Sodium Chloride And Potassium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210602",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212347",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "SODIUM CHLORIDE; POTASSIUM CHLORIDE",
"StrengthNumber": "450; 150",
"StrengthUnit": "mg/100mL; mg/100mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2024-05-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210602",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium Chloride in Sodium Chloride Injection, USP is indicated as a source of water and electrolytes.",
"Description": "Potassium Chloride in Sodium Chloride Injection, USP is a sterile, nonpyrogenic, solution for fluid and electrolyte replenishment in a single dose container for intravenous administration. It contains no antimicrobial agents. Composition, osmolarity, pH and ionic concentration are shown in Table 1. The flexible plastic container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers (freeflex® bag). The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers."
},
{
"NDCCode": "65841-683-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (65841-683-10) ",
"NDC11Code": "65841-0683-10",
"ProductNDC": "65841-683",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077633",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090127",
"SamplePackage": "N"
},
{
"NDCCode": "69097-683-21",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (69097-683-21) / 10 CAPSULE in 1 BLISTER PACK (69097-683-19) ",
"NDC11Code": "69097-0683-21",
"ProductNDC": "69097-683",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin Capsules, Cv",
"NonProprietaryName": "Pregabalin Capsules, Cv",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20200110",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212280",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Deprecated",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200110",
"SamplePackage": "N",
"IndicationAndUsage": ". Pregabalin capsules are indicated for. : 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.",
"Description": "Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with co-processed starch and talc as inactive ingredients. The capsule shell for 25 mg, 50 mg & 150 mg contains: gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The capsule shell for 75 mg, 100 mg, 200 mg, 225 mg & 300 mg contains: FD &C Blue 1, FD& C Red 40, FD& C Yellow 6, gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg capsule imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac."
},
{
"NDCCode": "71919-683-10",
"PackageDescription": "100 mL in 1 BOTTLE, GLASS (71919-683-10) ",
"NDC11Code": "71919-0683-10",
"ProductNDC": "71919-683",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Titanium Metallicum",
"NonProprietaryName": "Titanium",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110517",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "TITANIUM",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2022-03-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20110517",
"SamplePackage": "N"
},
{
"NDCCode": "72245-683-10",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (72245-683-10) ",
"NDC11Code": "72245-0683-10",
"ProductNDC": "72245-683",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prolate",
"NonProprietaryName": "Oxycodone And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040608",
"LabelerName": "Forte Bio-Pharma LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "10; 300",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200217",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over course of therapy [see WARNINGS], reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone hydrochloride and acetaminophen are available in tablets for oral administration. Each PROLATE ®, 5 mg/300 mg contains:. Oxycodone Hydrochloride USP…….. 5 mg*. (*5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg Oxycodone). Acetaminophen USP……………... 300 mg. Each PROLATE ®, 7.5 mg/300 mg contains:. Oxycodone Hydrochloride USP….. 7.5 mg*. (*7.5 mg Oxycodone Hydrochloride is equivalent to 6.7228 mg Oxycodone). Acetaminophen USP…………….. 300 mg. Each PROLATE ® , 10 mg/300 mg contains:. Oxycodone Hydrochloride USP….. 10 mg*. (*10 mg Oxycodone Hydrochloride is equivalent to 8.9637 mg Oxycodone). Acetaminophen USP……………. 300 mg. Inactive Ingredients. The tablets contain: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. In addition the 5 mg/300 mg strength contains D&C Yellow #10; the 7.5 mg/300 mg strength contains FD&C Red #40 Aluminum Lake; the 10 mg/300 mg strength contains FD&C Yellow #6 Aluminum Lake. Oxycodone and acetaminophen tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C 18H 21NO 4HCl and the molecular weight is 351.82. It is derived from the opium alkaloid thebaine, and may be represented by the following structural formula:. Oxycodone and acetaminophen tablets contain acetaminophen, 4'-hydroxyacetanilide, a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C 8H 9NO 2 and the molecular weight is 151.16. It may be represented by the following structural formula:."
},
{
"NDCCode": "62135-002-24",
"PackageDescription": "2 TRAY in 1 BOX (62135-002-24) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (62135-002-51) ",
"NDC11Code": "62135-0002-24",
"ProductNDC": "62135-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lactulose",
"NonProprietaryName": "Lactulose",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20181123",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209517",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "LACTULOSE",
"StrengthNumber": "10",
"StrengthUnit": "g/15mL",
"Pharm_Classes": "Acidifying Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240319",
"SamplePackage": "N",
"IndicationAndUsage": "For the treatment of constipation. In patients with a history of chronic constipation, lactulose solution therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.",
"Description": "Lactulose is a synthetic disaccharide in solution form for oral administration. Each 15 mL of Lactulose Solution, USP contains: 10 g lactulose (and less than 1.6 g galactose, less than 1.2 g lactose, and 1.2 g or less of other sugars). Also contains water. The pH range is 2.5 to 6.5. Lactulose is a colonic acidifier which promotes laxation. The chemical name for lactulose is 4-O-β-D-galactopyranosyl-D-fructofuranose. The molecular formula is C 12H 22O 11. It has the following structural formula:. The molecular weight is 342.30. It is freely soluble in water."
},
{
"NDCCode": "62135-004-24",
"PackageDescription": "2 TRAY in 1 BOX (62135-004-24) / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE (62135-004-43) ",
"NDC11Code": "62135-0004-24",
"ProductNDC": "62135-004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lactulose",
"NonProprietaryName": "Lactulose",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20181123",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209517",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "LACTULOSE",
"StrengthNumber": "10",
"StrengthUnit": "g/15mL",
"Pharm_Classes": "Acidifying Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240319",
"SamplePackage": "N",
"IndicationAndUsage": "For the treatment of constipation. In patients with a history of chronic constipation, lactulose solution therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.",
"Description": "Lactulose is a synthetic disaccharide in solution form for oral administration. Each 15 mL of Lactulose Solution, USP contains: 10 g lactulose (and less than 1.6 g galactose, less than 1.2 g lactose, and 1.2 g or less of other sugars). Also contains water. The pH range is 2.5 to 6.5. Lactulose is a colonic acidifier which promotes laxation. The chemical name for lactulose is 4-O-β-D-galactopyranosyl-D-fructofuranose. The molecular formula is C 12H 22O 11. It has the following structural formula:. The molecular weight is 342.30. It is freely soluble in water."
},
{
"NDCCode": "62135-011-24",
"PackageDescription": "2 TRAY in 1 BOX (62135-011-24) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (62135-011-59) ",
"NDC11Code": "62135-0011-24",
"ProductNDC": "62135-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amantadine Hydrochloride",
"NonProprietaryName": "Amantadine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "19930628",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074028",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "AMANTADINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19930628",
"SamplePackage": "N",
"IndicationAndUsage": "Amantadine hydrochloride oral solution is indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride oral solution is also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. Influenza A Prophylaxis. Amantadine hydrochloride oral solution is indicated for chemoprophylaxis against signs and symptoms of influenza A virus infection. Because amantadine hydrochloride oral solution does not completely prevent the host immune response to influenza A infection, individuals who take this drug may still develop immune responses to natural disease or vaccination and may be protected when later exposed to antigenically related viruses. Following vaccination during an influenza A outbreak, amantadine hydrochloride oral solution prophylaxis should be considered for the 2 to 4 week time period required to develop an antibody response. Influenza A Treatment. Amantadine hydrochloride oral solution is also indicated in the treatment of uncomplicated respiratory tract illness caused by influenza A virus strains especially when administered early in the course of illness. There are no well-controlled clinical studies demonstrating that treatment with amantadine hydrochloride oral solution will avoid the development of influenza A virus pneumonitis or other complications in high risk patients. There is no clinical evidence indicating that amantadine hydrochloride oral solution is effective in the prophylaxis or treatment of viral respiratory tract illnesses other than those caused by influenza A virus strains. The following points should be considered before initiating treatment or prophylaxis with amantadine hydrochloride oral solution. : 1 Amantadine hydrochloride oral solution is not a substitute for early vaccination on an annual basis as recommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices.",
"Description": "Amantadine Hydrochloride Oral Solution, USP. Rx only. DESCRIPTION. Amantadine Hydrochloride Oral Solution, USP is designated generically as amantadine hydrochloride and chemically as 1-adamantanamine hydrochloride. Amantadine hydrochloride is a stable white or nearly white crystalline powder, freely soluble in water and soluble in alcohol and in chloroform. Amantadine hydrochloride has pharmacological actions as both an anti-Parkinson and an antiviral drug. Amantadine Hydrochloride Oral Solution, USP is available in oral solution. Amantadine Hydrochloride Oral Solution, USP contains 50 mg of amantadine hydrochloride per 5 mL and has the following inactive ingredients: sorbitol solution, anhydrous citric acid, methylparaben, propylparaben, propylene glycol, purified water, and wild cherry flavor."
},
{
"NDCCode": "62135-050-24",
"PackageDescription": "2 TRAY in 1 BOX (62135-050-24) / 10 CUP in 1 TRAY / 25 mL in 1 CUP (62135-050-52) ",
"NDC11Code": "62135-0050-24",
"ProductNDC": "62135-050",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydroxyzine Hydrochloride",
"NonProprietaryName": "Hydroxyzine Hydrochloride",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "19820412",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA087294",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "HYDROXYZINE DIHYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/25mL",
"Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2024-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240923",
"SamplePackage": "N",
"IndicationAndUsage": "For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus. As a sedative when used as premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.",
"Description": "Hydroxyzine hydrochloride is designated chemically as (±)-2-[2-[4-( p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride. Its structural formula is as follows:. Inactive Ingredientsfor Hydroxyzine Hydrochloride Oral Solution, USP (Syrup) are: alcohol 0.5% (v/v); sucrose; methylparaben; peppermint flavor; propylene glycol; propylparaben; and purified water. It may also containcitric acid anhydrous or sodium citrate dihydrate for pH adjustment. The pH range is between 2.0 and 4.3."
},
{
"NDCCode": "62135-142-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (62135-142-10) ",
"NDC11Code": "62135-0142-10",
"ProductNDC": "62135-142",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benztropine Mesylate",
"NonProprietaryName": "Benztropine Mesylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19920123",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA081265",
"LabelerName": "Chartwell RX, LLC.",
"SubstanceName": "BENZTROPINE MESYLATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Antihistamine [EPC], Cholinergic Antagonists [MoA], Histamine Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210430",
"SamplePackage": "N",
"IndicationAndUsage": "Benztropine Mesylate Tablets, USP are indicated for use as an adjunct in the therapy of all forms of parkinsonism. Useful also in the control of extrapyramidal disorders (except tardive dyskinesia-see PRECAUTIONS) due to neuroleptic drugs (e.g., phenothiazines).",
"Description": "Benztropine mesylate is a synthetic compound containing structural features found in atropine and diphenhydramine. It is designated chemically as 3α-(Diphenylmethoxy)-1αH, 5αH-tropane methanesulfonate. Its molecular formula is C 21 H 25 NOCH 4 O 3 S, and its structural formula is:. Benztropine mesylate is a crystalline white powder, very soluble in water, and has a molecular weight of 403.54. Each benztropine mesylate tablet for oral administration contains benztropine mesylate, USP, 0.5 mg, 1 mg, or 2 mg. Each tablet contains the following inactive ingredients: dibasic calcium phosphate (hydrous), anhydrous lactose, magnesium stearate, microcrystalline cellulose, and pregelatinized starch."
},
{
"NDCCode": "62135-144-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (62135-144-10) ",
"NDC11Code": "62135-0144-10",
"ProductNDC": "62135-144",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benztropine Mesylate",
"NonProprietaryName": "Benztropine Mesylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19920123",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA081265",
"LabelerName": "Chartwell RX, LLC.",
"SubstanceName": "BENZTROPINE MESYLATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Antihistamine [EPC], Cholinergic Antagonists [MoA], Histamine Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210430",
"SamplePackage": "N",
"IndicationAndUsage": "Benztropine Mesylate Tablets, USP are indicated for use as an adjunct in the therapy of all forms of parkinsonism. Useful also in the control of extrapyramidal disorders (except tardive dyskinesia-see PRECAUTIONS) due to neuroleptic drugs (e.g., phenothiazines).",
"Description": "Benztropine mesylate is a synthetic compound containing structural features found in atropine and diphenhydramine. It is designated chemically as 3α-(Diphenylmethoxy)-1αH, 5αH-tropane methanesulfonate. Its molecular formula is C 21 H 25 NOCH 4 O 3 S, and its structural formula is:. Benztropine mesylate is a crystalline white powder, very soluble in water, and has a molecular weight of 403.54. Each benztropine mesylate tablet for oral administration contains benztropine mesylate, USP, 0.5 mg, 1 mg, or 2 mg. Each tablet contains the following inactive ingredients: dibasic calcium phosphate (hydrous), anhydrous lactose, magnesium stearate, microcrystalline cellulose, and pregelatinized starch."
},
{
"NDCCode": "62135-189-23",
"PackageDescription": "2 TRAY in 1 BOX (62135-189-23) / 10 CUP in 1 TRAY / 20 mL in 1 CUP (62135-189-20) ",
"NDC11Code": "62135-0189-23",
"ProductNDC": "62135-189",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Albuterol Sulfate",
"NonProprietaryName": "Albuterol Sulfate",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "20070626",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077788",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "ALBUTEROL SULFATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250326",
"SamplePackage": "N",
"IndicationAndUsage": "Albuterol Sulfate Syrup is indicated for the relief of bronchospasm in adults and children 2 years of age and older with reversible obstructive airway disease.",
"Description": "Albuterol Sulfate Syrup contains albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta 2-adrenergic bronchodilator. Albuterol sulfate has the chemical name α 1-[( tert-butylamino)methyl]-4-hydroxy- m-xylene-α,α'-diolsulfate (2:1) (salt) and the following chemical structure:. (C 13H 21NO 3) 2H 2SO 4 M.W. 576.7. Albuterol sulfate is a white or practically white powder freely soluble in water and slightly soluble in alcohol, in chloroform, and in ether per USP definition. The World Health Organization recommended name for albuterol base is salbutamol. Albuterol Sulfate Syrup for oral administration contains 2 mg of albuterol as 2.4 mg of albuterol sulfate in each teaspoonful (5 mL). Albuterol Sulfate Syrup also contains the inactive ingredients Purified water, hypromellose, citric acid anhydrous, sodium citrate dihydrate, sodium benzoate, sorbitol solution, strawberry flavor, and FD&C Yellow # 6. The pH of the syrup is 3.2 to 4.2."
},
{
"NDCCode": "62135-189-24",
"PackageDescription": "2 TRAY in 1 BOX (62135-189-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-189-05) ",
"NDC11Code": "62135-0189-24",
"ProductNDC": "62135-189",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Albuterol Sulfate",
"NonProprietaryName": "Albuterol Sulfate",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "20070626",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077788",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "ALBUTEROL SULFATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250326",
"SamplePackage": "N",
"IndicationAndUsage": "Albuterol Sulfate Syrup is indicated for the relief of bronchospasm in adults and children 2 years of age and older with reversible obstructive airway disease.",
"Description": "Albuterol Sulfate Syrup contains albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta 2-adrenergic bronchodilator. Albuterol sulfate has the chemical name α 1-[( tert-butylamino)methyl]-4-hydroxy- m-xylene-α,α'-diolsulfate (2:1) (salt) and the following chemical structure:. (C 13H 21NO 3) 2H 2SO 4 M.W. 576.7. Albuterol sulfate is a white or practically white powder freely soluble in water and slightly soluble in alcohol, in chloroform, and in ether per USP definition. The World Health Organization recommended name for albuterol base is salbutamol. Albuterol Sulfate Syrup for oral administration contains 2 mg of albuterol as 2.4 mg of albuterol sulfate in each teaspoonful (5 mL). Albuterol Sulfate Syrup also contains the inactive ingredients Purified water, hypromellose, citric acid anhydrous, sodium citrate dihydrate, sodium benzoate, sorbitol solution, strawberry flavor, and FD&C Yellow # 6. The pH of the syrup is 3.2 to 4.2."
},
{
"NDCCode": "62135-196-24",
"PackageDescription": "2 TRAY in 1 BOX (62135-196-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-196-45) ",
"NDC11Code": "62135-0196-24",
"ProductNDC": "62135-196",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valproic Acid",
"NonProprietaryName": "Valproic Acid",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20001222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075782",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "VALPROIC ACID",
"StrengthNumber": "250",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240528",
"SamplePackage": "N",
"IndicationAndUsage": "Valproic acid oral solution is indicated for: 1 Monotherapy and adjunctive therapy of complex partial seizures; sole and adjunctive therapy of simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures ( 1) .",
"Description": "Valproic acid is a carboxylic acid designated as 2-propylpentanoic acid. It is also known as dipropylacetic acid. Valproic acid has the following structure. Valproic acid (pKa 4.8) has a molecular weight of 144 and occurs as a colorless liquid with a characteristic odor. It is slightly soluble in water (1.3 mg/mL) and very soluble in organic solvents. Valproic acid oral solution, USP is an antiepileptic for oral administration. The oral solution contains the equivalent of 250 mg valproic acid per 5 mL as the sodium salt. Inactive Ingredients. Oral Solution: Glycerin, methylparaben, propylparaben, sodium hydroxide, sorbitol, sucrose, purified water, FD&C Red No. 40 and flavor wild cherry."
}
]
}
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<NDCList>
<NDC>
<NDCCode>62135-683-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (62135-683-10) </PackageDescription>
<NDC11Code>62135-0683-10</NDC11Code>
<ProductNDC>62135-683</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075972</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>850</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220406</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride tablets is 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, USP is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5 HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of Metformin Hydrochloride is 6.68. Metformin hydrochloride tablets, USP contain 500 mg, 625 mg, 750 mg, 850 mg, or 1000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 487.41 mg, 584.90 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients microcrystalline cellulose, copovidone, hydroxypropyl methylcellulose, crospovidone, talc, magnesium stearate, titanium dioxide, polyethylene glycol, and polysorbate.</Description>
</NDC>
<NDC>
<NDCCode>62135-683-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (62135-683-05) </PackageDescription>
<NDC11Code>62135-0683-05</NDC11Code>
<ProductNDC>62135-683</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>850</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220406</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride tablets is 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, USP is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5 HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of Metformin Hydrochloride is 6.68. Metformin hydrochloride tablets, USP contain 500 mg, 625 mg, 750 mg, 850 mg, or 1000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 487.41 mg, 584.90 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients microcrystalline cellulose, copovidone, hydroxypropyl methylcellulose, crospovidone, talc, magnesium stearate, titanium dioxide, polyethylene glycol, and polysorbate.</Description>
</NDC>
<NDC>
<NDCCode>62135-683-18</NDCCode>
<PackageDescription>180 TABLET in 1 BOTTLE (62135-683-18) </PackageDescription>
<NDC11Code>62135-0683-18</NDC11Code>
<ProductNDC>62135-683</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020124</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075972</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>850</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220406</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride tablets is 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, USP is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5 HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of Metformin Hydrochloride is 6.68. Metformin hydrochloride tablets, USP contain 500 mg, 625 mg, 750 mg, 850 mg, or 1000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 487.41 mg, 584.90 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients microcrystalline cellulose, copovidone, hydroxypropyl methylcellulose, crospovidone, talc, magnesium stearate, titanium dioxide, polyethylene glycol, and polysorbate.</Description>
</NDC>
<NDC>
<NDCCode>62135-683-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (62135-683-30) </PackageDescription>
<NDC11Code>62135-0683-30</NDC11Code>
<ProductNDC>62135-683</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020124</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075972</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>850</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220406</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride tablets is 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, USP is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5 HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of Metformin Hydrochloride is 6.68. Metformin hydrochloride tablets, USP contain 500 mg, 625 mg, 750 mg, 850 mg, or 1000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 487.41 mg, 584.90 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients microcrystalline cellulose, copovidone, hydroxypropyl methylcellulose, crospovidone, talc, magnesium stearate, titanium dioxide, polyethylene glycol, and polysorbate.</Description>
</NDC>
<NDC>
<NDCCode>62135-683-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (62135-683-90) </PackageDescription>
<NDC11Code>62135-0683-90</NDC11Code>
<ProductNDC>62135-683</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020124</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075972</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>850</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220406</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride tablets is 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, USP is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5 HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of Metformin Hydrochloride is 6.68. Metformin hydrochloride tablets, USP contain 500 mg, 625 mg, 750 mg, 850 mg, or 1000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 487.41 mg, 584.90 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients microcrystalline cellulose, copovidone, hydroxypropyl methylcellulose, crospovidone, talc, magnesium stearate, titanium dioxide, polyethylene glycol, and polysorbate.</Description>
</NDC>
<NDC>
<NDCCode>13811-683-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (13811-683-10)</PackageDescription>
<NDC11Code>13811-0683-10</NDC11Code>
<ProductNDC>13811-683</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aripiprazole</ProprietaryName>
<NonProprietaryName>Aripiprazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150428</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202101</ApplicationNumber>
<LabelerName>Trigen Laboratories, LLC</LabelerName>
<SubstanceName>ARIPIPRAZOLE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-10-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>25021-683-10</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (25021-683-10) / 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>25021-0683-10</NDC11Code>
<ProductNDC>25021-683</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketamine Hydrochloride</ProprietaryName>
<NonProprietaryName>Ketamine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20230715</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216809</ApplicationNumber>
<LabelerName>Sagent Pharmaceuticals</LabelerName>
<SubstanceName>KETAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>General Anesthesia [PE], General Anesthetic [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2023-07-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ketamine hydrochloride injection is indicated: : 1 as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation. , 2 for the induction of anesthesia prior to the administration of other general anesthetic agents. , 3 as a supplement to other anesthetic agents. .</IndicationAndUsage>
<Description>Ketamine hydrochloride injection, USP for intravenous or intramuscular use, contains ketamine, a nonbarbiturate general anesthetic. Ketamine hydrochloride, USP is a white or almost white, crystalline powder and has a molecular formula of C13H16ClNOHCl and a molecular weight of 274.19. The chemical name for ketamine hydrochloride is 2-(2-chlorophenyl)-2-(methylamino) cyclohexan-1-one hydrochloride. The chemical structure of ketamine hydrochloride is:. It is formulated as a slightly acidic (pH 3.5 to 5.5) sterile solution for intravenous or intramuscular injection. Each milliliter (mL) of the multiple-dose vials contain either 10 mg ketamine base (equivalent to 11.53 mg ketamine hydrochloride), 50 mg ketamine base (equivalent to 57.67 mg ketamine hydrochloride) or 100 mg ketamine base (equivalent to 115.33 mg ketamine hydrochloride) and not more than 0.10 mg/mL benzethonium chloride added as a preservative in water for injection. The 10 mg/mL solution has been made isotonic with 6.60 mg sodium chloride.</Description>
</NDC>
<NDC>
<NDCCode>35000-683-10</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (35000-683-10) </PackageDescription>
<NDC11Code>35000-0683-10</NDC11Code>
<ProductNDC>35000-683</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hello Peace Out Plaque</ProprietaryName>
<ProprietaryNameSuffix>Peace Out, Plaque Antigingivitis</ProprietaryNameSuffix>
<NonProprietaryName>Cetylpyridinium Chloride</NonProprietaryName>
<DosageFormName>MOUTHWASH</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20230701</StartMarketingDate>
<EndMarketingDate>20271230</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Colgate-Palmolive Company</LabelerName>
<SubstanceName>CETYLPYRIDINIUM CHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/20mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-11-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230701</StartMarketingDatePackage>
<EndMarketingDatePackage>20271230</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent and reduce plaque and gingivitis. helps control plaque bacteria that contribute to the development of gingivitis, an early form of gum disease, and bleeding gums.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>35356-683-10</NDCCode>
<PackageDescription>10 TABLET in 1 BOTTLE (35356-683-10)</PackageDescription>
<NDC11Code>35356-0683-10</NDC11Code>
<ProductNDC>35356-683</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naproxen</ProprietaryName>
<NonProprietaryName>Naproxen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078250</ApplicationNumber>
<LabelerName>Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC</LabelerName>
<SubstanceName>NAPROXEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-03-26</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>46708-683-10</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (46708-683-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>46708-0683-10</NDC11Code>
<ProductNDC>46708-683</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rivaroxaban</ProprietaryName>
<NonProprietaryName>Rivaroxaban</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250514</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210301</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>RIVAROXABAN</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250514</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rivaroxaban tablet is a factor Xa inhibitor indicated: to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation (1.1) for treatment of deep vein thrombosis (DVT) (1.2) for treatment of pulmonary embolism (PE) (1.3) for reduction in the risk of recurrence of DVT or PE (1.4) for prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery (1.5) for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients (1.6) to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) (1.7) to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD (1.8) for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years (1.9). for thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure (1.10).</IndicationAndUsage>
<Description>Rivaroxaban, USP, a factor Xa (FXa) inhibitor, is the active ingredient in rivaroxaban tablets, USP with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban, USP is C19H18ClN3O5S and the molecular weight is 435.88. The structural formula is. Rivaroxaban, USP is a pure (S)-enantiomer. It is an white to yellowish powder. Rivaroxaban, USP is soluble in dimethyl sulfoxide, practically insoluble to very slightly soluble in acetone and water. Each rivaroxaban tablet, USP contains 2.5 mg, 10 mg, 15 mg or 20 mg of rivaroxaban, USP. The inactive ingredients of rivaroxaban tablets, USP are: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. Additionally, the proprietary film coating mixture used for rivaroxaban 2.5 mg tablet is Opadry® Yellow containing D&C yellow #10 aluminium lake, hypromellose, iron oxide red, iron oxide yellow, polyethylene glycol 6000, titanium dioxide, and for rivaroxaban 10 mg tablet is Opadry® Pink containing hypromellose, iron oxide red, polyethylene glycol 6000, talc, titanium dioxide, and for rivaroxaban 15 mg tablet and 20 mg tablet is Opadry® Brown containing hypromellose, iron oxide black, iron oxide red, polyethylene glycol 8000, and titanium dioxide. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>50844-683-10</NDCCode>
<PackageDescription>3 BOTTLE in 1 CARTON (50844-683-10) > 36 TABLET, CHEWABLE in 1 BOTTLE</PackageDescription>
<NDC11Code>50844-0683-10</NDC11Code>
<ProductNDC>50844-683</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>St. Joseph Chewable Low Dose Aspirin</ProprietaryName>
<NonProprietaryName>Aspirin</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120305</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG PRODUCT MANUFACTURED UNDER CONTRACT</MarketingCategoryName>
<LabelerName>L.N.K. International, Inc.</LabelerName>
<SubstanceName>ASPIRIN</SubstanceName>
<StrengthNumber>81</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>51407-683-10</NDCCode>
<PackageDescription>36 BOTTLE in 1 BOX (51407-683-10) / 1000 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>51407-0683-10</NDC11Code>
<ProductNDC>51407-683</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Famotidine</ProprietaryName>
<NonProprietaryName>Famotidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010416</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075805</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>FAMOTIDINE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230308</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Famotidine tablets are indicated in adult and pediatric patients 40 kg and above for the treatment of. active duodenal ulcer (DU). active gastric ulcer(GU). symptomatic non-erosive gastroesophageal reflux disease (GERD). erosive esophagitis due to GERD, diagnosed by biopsy. Famotidine tablets are indicated in adults for the: treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison Syndrome, multiple endocrine neoplasias). reduction of the risk of duodenal ulcer recurrence.</IndicationAndUsage>
<Description>The active ingredient in Famotidine tablets is a histamine-2 (H2) receptor antagonist. Famotidine is N’-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The empirical formula of famotidine is C 8H 15N 7O 2S 3and its molecular weight is 337.43. Its structural formula is:. Each Famotidine tablet for oral administration contains either 20 mg or 40 mg of famotidine and the following inactive ingredients: hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch (modified corn starch), sodium starch glycolate, talc, titanium dioxide and triacetin. Famotidine is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol.</Description>
</NDC>
<NDC>
<NDCCode>51991-683-10</NDCCode>
<PackageDescription>1000 TABLET, DELAYED RELEASE in 1 BOTTLE (51991-683-10) </PackageDescription>
<NDC11Code>51991-0683-10</NDC11Code>
<ProductNDC>51991-683</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rabeprazole Sodium</ProprietaryName>
<NonProprietaryName>Rabeprazole Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170601</StartMarketingDate>
<EndMarketingDate>20200228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204237</ApplicationNumber>
<LabelerName>Breckenridge Pharmaceutical, Inc.</LabelerName>
<SubstanceName>RABEPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-02-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170601</StartMarketingDatePackage>
<EndMarketingDatePackage>20200228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>57664-683-57</NDCCode>
<PackageDescription>10 BAG in 1 BOX (57664-683-57) / 300 mL in 1 BAG (57664-683-31) </PackageDescription>
<NDC11Code>57664-0683-57</NDC11Code>
<ProductNDC>57664-683</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Linezolid</ProprietaryName>
<NonProprietaryName>Linezolid</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20170201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207354</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>LINEZOLID</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/300mL</StrengthUnit>
<Pharm_Classes>Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Linezolid injection is an oxazolidinone-class antibacterial indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia (1.1); Community-acquired pneumonia (1.2); Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis (1.3); Uncomplicated skin and skin structure infections (1.4); Vancomycin-resistant Enterococcus faecium infections. (1.5). Limitations of Use (1.6) : 1 Linezolid injection is not indicated for the treatment of Gram-negative infections., 2 The safety and efficacy of linezolid injection formulations given for longer than 28 days have not been evaluated in controlled clinical trials.</IndicationAndUsage>
<Description>Linezolid injection contains linezolid, which is a synthetic antibacterial agent of the oxazolidinone class. The chemical name for linezolid is (S)-N-[[3-[3-Fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl] methyl]-acetamide. The empirical formula is C16H20FN3O4. Its molecular weight is 337.35, and its chemical structure is represented below. Linezolid injection is supplied as a ready-to-use sterile isotonic solution for intravenous infusion. Each mL contains 2 mg of linezolid. Inactive ingredients are dextrose monohydrate 50.24 mg/mL in an aqueous vehicle for intravenous administration, sodium citrate dihydrate 1.64 mg/mL, and citric acid anhydrous 0.85 mg/mL. Sodium hydroxide NF and/or hydrochloric acid NF are used to adjust the pH. The sodium (Na+) content is 0.38 mg/mL (5 mEq/300 mL bag and 1.7 mEq/100 mL bag).</Description>
</NDC>
<NDC>
<NDCCode>57896-683-10</NDCCode>
<PackageDescription>1000 TABLET, COATED in 1 BOTTLE (57896-683-10) </PackageDescription>
<NDC11Code>57896-0683-10</NDC11Code>
<ProductNDC>57896-683</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Geri-dryl Allergy Relief</ProprietaryName>
<NonProprietaryName>Diphenhydramine Hcl</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Geri-Care Pharmaceutical Corp</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever and other upper respiratory allergies:. runny nose.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62332-683-10</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (62332-683-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>62332-0683-10</NDC11Code>
<ProductNDC>62332-683</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rivaroxaban</ProprietaryName>
<NonProprietaryName>Rivaroxaban</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250514</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210301</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>RIVAROXABAN</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250514</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rivaroxaban tablet is a factor Xa inhibitor indicated: to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation (1.1) for treatment of deep vein thrombosis (DVT) (1.2) for treatment of pulmonary embolism (PE) (1.3) for reduction in the risk of recurrence of DVT or PE (1.4) for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery (1.5) for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients (1.6) to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) (1.7) to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD (1.8) for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years (1.9). for thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure (1.10).</IndicationAndUsage>
<Description>Rivaroxaban, USP, a factor Xa (FXa) inhibitor, is the active ingredient in rivaroxaban tablets, USP with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban, USP is C19H18ClN3O5S and the molecular weight is 435.88. The structural formula is. Rivaroxaban, USP is a pure (S)-enantiomer. It is an white to yellowish powder. Rivaroxaban, USP is soluble in dimethyl sulfoxide, practically insoluble to very slightly soluble in acetone and water. Each rivaroxaban tablet, USP contains 2.5 mg, 10 mg, 15 mg or 20 mg of rivaroxaban, USP. The inactive ingredients of rivaroxaban tablets, USP are: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. Additionally, the proprietary film coating mixture used for rivaroxaban 2.5 mg tablet is Opadry® Yellow containing D&C yellow #10 aluminium lake, hypromellose, iron oxide red, iron oxide yellow, polyethylene glycol 6000, titanium dioxide, and for rivaroxaban 10 mg tablet is Opadry® Pink containing hypromellose, iron oxide red, polyethylene glycol 6000, talc, titanium dioxide, and for rivaroxaban 15 mg tablet and 20 mg tablet is Opadry® Brown containing hypromellose, iron oxide black, iron oxide red, polyethylene glycol 8000, and titanium dioxide. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>63323-683-10</NDCCode>
<PackageDescription>10 BAG in 1 CARTON (63323-683-10) / 1000 mL in 1 BAG (63323-683-01) </PackageDescription>
<NDC11Code>63323-0683-10</NDC11Code>
<ProductNDC>63323-683</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride In Sodium Chloride</ProprietaryName>
<NonProprietaryName>Sodium Chloride And Potassium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20210602</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212347</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>SODIUM CHLORIDE; POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>450; 150</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210602</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium Chloride in Sodium Chloride Injection, USP is indicated as a source of water and electrolytes.</IndicationAndUsage>
<Description>Potassium Chloride in Sodium Chloride Injection, USP is a sterile, nonpyrogenic, solution for fluid and electrolyte replenishment in a single dose container for intravenous administration. It contains no antimicrobial agents. Composition, osmolarity, pH and ionic concentration are shown in Table 1. The flexible plastic container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers (freeflex® bag). The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers.</Description>
</NDC>
<NDC>
<NDCCode>65841-683-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (65841-683-10) </PackageDescription>
<NDC11Code>65841-0683-10</NDC11Code>
<ProductNDC>65841-683</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077633</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69097-683-21</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (69097-683-21) / 10 CAPSULE in 1 BLISTER PACK (69097-683-19) </PackageDescription>
<NDC11Code>69097-0683-21</NDC11Code>
<ProductNDC>69097-683</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin Capsules, Cv</ProprietaryName>
<NonProprietaryName>Pregabalin Capsules, Cv</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200110</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212280</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>. Pregabalin capsules are indicated for. : 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
<Description>Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with co-processed starch and talc as inactive ingredients. The capsule shell for 25 mg, 50 mg & 150 mg contains: gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The capsule shell for 75 mg, 100 mg, 200 mg, 225 mg & 300 mg contains: FD &C Blue 1, FD& C Red 40, FD& C Yellow 6, gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg capsule imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac.</Description>
</NDC>
<NDC>
<NDCCode>71919-683-10</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE, GLASS (71919-683-10) </PackageDescription>
<NDC11Code>71919-0683-10</NDC11Code>
<ProductNDC>71919-683</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Titanium Metallicum</ProprietaryName>
<NonProprietaryName>Titanium</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110517</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>TITANIUM</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-03-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110517</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>72245-683-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (72245-683-10) </PackageDescription>
<NDC11Code>72245-0683-10</NDC11Code>
<ProductNDC>72245-683</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prolate</ProprietaryName>
<NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200217</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040608</ApplicationNumber>
<LabelerName>Forte Bio-Pharma LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>10; 300</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over course of therapy [see WARNINGS], reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone hydrochloride and acetaminophen are available in tablets for oral administration. Each PROLATE ®, 5 mg/300 mg contains:. Oxycodone Hydrochloride USP…….. 5 mg*. (*5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg Oxycodone). Acetaminophen USP……………... 300 mg. Each PROLATE ®, 7.5 mg/300 mg contains:. Oxycodone Hydrochloride USP….. 7.5 mg*. (*7.5 mg Oxycodone Hydrochloride is equivalent to 6.7228 mg Oxycodone). Acetaminophen USP…………….. 300 mg. Each PROLATE ® , 10 mg/300 mg contains:. Oxycodone Hydrochloride USP….. 10 mg*. (*10 mg Oxycodone Hydrochloride is equivalent to 8.9637 mg Oxycodone). Acetaminophen USP……………. 300 mg. Inactive Ingredients. The tablets contain: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. In addition the 5 mg/300 mg strength contains D&C Yellow #10; the 7.5 mg/300 mg strength contains FD&C Red #40 Aluminum Lake; the 10 mg/300 mg strength contains FD&C Yellow #6 Aluminum Lake. Oxycodone and acetaminophen tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C 18H 21NO 4HCl and the molecular weight is 351.82. It is derived from the opium alkaloid thebaine, and may be represented by the following structural formula:. Oxycodone and acetaminophen tablets contain acetaminophen, 4'-hydroxyacetanilide, a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C 8H 9NO 2 and the molecular weight is 151.16. It may be represented by the following structural formula:.</Description>
</NDC>
<NDC>
<NDCCode>62135-002-24</NDCCode>
<PackageDescription>2 TRAY in 1 BOX (62135-002-24) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (62135-002-51) </PackageDescription>
<NDC11Code>62135-0002-24</NDC11Code>
<ProductNDC>62135-002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lactulose</ProprietaryName>
<NonProprietaryName>Lactulose</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181123</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209517</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>LACTULOSE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/15mL</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240319</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the treatment of constipation. In patients with a history of chronic constipation, lactulose solution therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.</IndicationAndUsage>
<Description>Lactulose is a synthetic disaccharide in solution form for oral administration. Each 15 mL of Lactulose Solution, USP contains: 10 g lactulose (and less than 1.6 g galactose, less than 1.2 g lactose, and 1.2 g or less of other sugars). Also contains water. The pH range is 2.5 to 6.5. Lactulose is a colonic acidifier which promotes laxation. The chemical name for lactulose is 4-O-β-D-galactopyranosyl-D-fructofuranose. The molecular formula is C 12H 22O 11. It has the following structural formula:. The molecular weight is 342.30. It is freely soluble in water.</Description>
</NDC>
<NDC>
<NDCCode>62135-004-24</NDCCode>
<PackageDescription>2 TRAY in 1 BOX (62135-004-24) / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE (62135-004-43) </PackageDescription>
<NDC11Code>62135-0004-24</NDC11Code>
<ProductNDC>62135-004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lactulose</ProprietaryName>
<NonProprietaryName>Lactulose</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181123</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209517</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>LACTULOSE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/15mL</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240319</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the treatment of constipation. In patients with a history of chronic constipation, lactulose solution therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.</IndicationAndUsage>
<Description>Lactulose is a synthetic disaccharide in solution form for oral administration. Each 15 mL of Lactulose Solution, USP contains: 10 g lactulose (and less than 1.6 g galactose, less than 1.2 g lactose, and 1.2 g or less of other sugars). Also contains water. The pH range is 2.5 to 6.5. Lactulose is a colonic acidifier which promotes laxation. The chemical name for lactulose is 4-O-β-D-galactopyranosyl-D-fructofuranose. The molecular formula is C 12H 22O 11. It has the following structural formula:. The molecular weight is 342.30. It is freely soluble in water.</Description>
</NDC>
<NDC>
<NDCCode>62135-011-24</NDCCode>
<PackageDescription>2 TRAY in 1 BOX (62135-011-24) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (62135-011-59) </PackageDescription>
<NDC11Code>62135-0011-24</NDC11Code>
<ProductNDC>62135-011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amantadine Hydrochloride</ProprietaryName>
<NonProprietaryName>Amantadine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19930628</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074028</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>AMANTADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19930628</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amantadine hydrochloride oral solution is indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride oral solution is also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. Influenza A Prophylaxis. Amantadine hydrochloride oral solution is indicated for chemoprophylaxis against signs and symptoms of influenza A virus infection. Because amantadine hydrochloride oral solution does not completely prevent the host immune response to influenza A infection, individuals who take this drug may still develop immune responses to natural disease or vaccination and may be protected when later exposed to antigenically related viruses. Following vaccination during an influenza A outbreak, amantadine hydrochloride oral solution prophylaxis should be considered for the 2 to 4 week time period required to develop an antibody response. Influenza A Treatment. Amantadine hydrochloride oral solution is also indicated in the treatment of uncomplicated respiratory tract illness caused by influenza A virus strains especially when administered early in the course of illness. There are no well-controlled clinical studies demonstrating that treatment with amantadine hydrochloride oral solution will avoid the development of influenza A virus pneumonitis or other complications in high risk patients. There is no clinical evidence indicating that amantadine hydrochloride oral solution is effective in the prophylaxis or treatment of viral respiratory tract illnesses other than those caused by influenza A virus strains. The following points should be considered before initiating treatment or prophylaxis with amantadine hydrochloride oral solution. : 1 Amantadine hydrochloride oral solution is not a substitute for early vaccination on an annual basis as recommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices.</IndicationAndUsage>
<Description>Amantadine Hydrochloride Oral Solution, USP. Rx only. DESCRIPTION. Amantadine Hydrochloride Oral Solution, USP is designated generically as amantadine hydrochloride and chemically as 1-adamantanamine hydrochloride. Amantadine hydrochloride is a stable white or nearly white crystalline powder, freely soluble in water and soluble in alcohol and in chloroform. Amantadine hydrochloride has pharmacological actions as both an anti-Parkinson and an antiviral drug. Amantadine Hydrochloride Oral Solution, USP is available in oral solution. Amantadine Hydrochloride Oral Solution, USP contains 50 mg of amantadine hydrochloride per 5 mL and has the following inactive ingredients: sorbitol solution, anhydrous citric acid, methylparaben, propylparaben, propylene glycol, purified water, and wild cherry flavor.</Description>
</NDC>
<NDC>
<NDCCode>62135-050-24</NDCCode>
<PackageDescription>2 TRAY in 1 BOX (62135-050-24) / 10 CUP in 1 TRAY / 25 mL in 1 CUP (62135-050-52) </PackageDescription>
<NDC11Code>62135-0050-24</NDC11Code>
<ProductNDC>62135-050</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydroxyzine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydroxyzine Hydrochloride</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19820412</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA087294</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>HYDROXYZINE DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/25mL</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240923</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus. As a sedative when used as premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Hydroxyzine hydrochloride is designated chemically as (±)-2-[2-[4-( p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride. Its structural formula is as follows:. Inactive Ingredientsfor Hydroxyzine Hydrochloride Oral Solution, USP (Syrup) are: alcohol 0.5% (v/v); sucrose; methylparaben; peppermint flavor; propylene glycol; propylparaben; and purified water. It may also containcitric acid anhydrous or sodium citrate dihydrate for pH adjustment. The pH range is between 2.0 and 4.3.</Description>
</NDC>
<NDC>
<NDCCode>62135-142-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE, PLASTIC (62135-142-10) </PackageDescription>
<NDC11Code>62135-0142-10</NDC11Code>
<ProductNDC>62135-142</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benztropine Mesylate</ProprietaryName>
<NonProprietaryName>Benztropine Mesylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920123</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA081265</ApplicationNumber>
<LabelerName>Chartwell RX, LLC.</LabelerName>
<SubstanceName>BENZTROPINE MESYLATE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Antihistamine [EPC], Cholinergic Antagonists [MoA], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Benztropine Mesylate Tablets, USP are indicated for use as an adjunct in the therapy of all forms of parkinsonism. Useful also in the control of extrapyramidal disorders (except tardive dyskinesia-see PRECAUTIONS) due to neuroleptic drugs (e.g., phenothiazines).</IndicationAndUsage>
<Description>Benztropine mesylate is a synthetic compound containing structural features found in atropine and diphenhydramine. It is designated chemically as 3α-(Diphenylmethoxy)-1αH, 5αH-tropane methanesulfonate. Its molecular formula is C 21 H 25 NOCH 4 O 3 S, and its structural formula is:. Benztropine mesylate is a crystalline white powder, very soluble in water, and has a molecular weight of 403.54. Each benztropine mesylate tablet for oral administration contains benztropine mesylate, USP, 0.5 mg, 1 mg, or 2 mg. Each tablet contains the following inactive ingredients: dibasic calcium phosphate (hydrous), anhydrous lactose, magnesium stearate, microcrystalline cellulose, and pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>62135-144-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE, PLASTIC (62135-144-10) </PackageDescription>
<NDC11Code>62135-0144-10</NDC11Code>
<ProductNDC>62135-144</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benztropine Mesylate</ProprietaryName>
<NonProprietaryName>Benztropine Mesylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920123</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA081265</ApplicationNumber>
<LabelerName>Chartwell RX, LLC.</LabelerName>
<SubstanceName>BENZTROPINE MESYLATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Antihistamine [EPC], Cholinergic Antagonists [MoA], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Benztropine Mesylate Tablets, USP are indicated for use as an adjunct in the therapy of all forms of parkinsonism. Useful also in the control of extrapyramidal disorders (except tardive dyskinesia-see PRECAUTIONS) due to neuroleptic drugs (e.g., phenothiazines).</IndicationAndUsage>
<Description>Benztropine mesylate is a synthetic compound containing structural features found in atropine and diphenhydramine. It is designated chemically as 3α-(Diphenylmethoxy)-1αH, 5αH-tropane methanesulfonate. Its molecular formula is C 21 H 25 NOCH 4 O 3 S, and its structural formula is:. Benztropine mesylate is a crystalline white powder, very soluble in water, and has a molecular weight of 403.54. Each benztropine mesylate tablet for oral administration contains benztropine mesylate, USP, 0.5 mg, 1 mg, or 2 mg. Each tablet contains the following inactive ingredients: dibasic calcium phosphate (hydrous), anhydrous lactose, magnesium stearate, microcrystalline cellulose, and pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>62135-189-23</NDCCode>
<PackageDescription>2 TRAY in 1 BOX (62135-189-23) / 10 CUP in 1 TRAY / 20 mL in 1 CUP (62135-189-20) </PackageDescription>
<NDC11Code>62135-0189-23</NDC11Code>
<ProductNDC>62135-189</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Albuterol Sulfate</ProprietaryName>
<NonProprietaryName>Albuterol Sulfate</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070626</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077788</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>ALBUTEROL SULFATE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250326</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Albuterol Sulfate Syrup is indicated for the relief of bronchospasm in adults and children 2 years of age and older with reversible obstructive airway disease.</IndicationAndUsage>
<Description>Albuterol Sulfate Syrup contains albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta 2-adrenergic bronchodilator. Albuterol sulfate has the chemical name α 1-[( tert-butylamino)methyl]-4-hydroxy- m-xylene-α,α'-diolsulfate (2:1) (salt) and the following chemical structure:. (C 13H 21NO 3) 2H 2SO 4 M.W. 576.7. Albuterol sulfate is a white or practically white powder freely soluble in water and slightly soluble in alcohol, in chloroform, and in ether per USP definition. The World Health Organization recommended name for albuterol base is salbutamol. Albuterol Sulfate Syrup for oral administration contains 2 mg of albuterol as 2.4 mg of albuterol sulfate in each teaspoonful (5 mL). Albuterol Sulfate Syrup also contains the inactive ingredients Purified water, hypromellose, citric acid anhydrous, sodium citrate dihydrate, sodium benzoate, sorbitol solution, strawberry flavor, and FD&C Yellow # 6. The pH of the syrup is 3.2 to 4.2.</Description>
</NDC>
<NDC>
<NDCCode>62135-189-24</NDCCode>
<PackageDescription>2 TRAY in 1 BOX (62135-189-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-189-05) </PackageDescription>
<NDC11Code>62135-0189-24</NDC11Code>
<ProductNDC>62135-189</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Albuterol Sulfate</ProprietaryName>
<NonProprietaryName>Albuterol Sulfate</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070626</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077788</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>ALBUTEROL SULFATE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250326</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Albuterol Sulfate Syrup is indicated for the relief of bronchospasm in adults and children 2 years of age and older with reversible obstructive airway disease.</IndicationAndUsage>
<Description>Albuterol Sulfate Syrup contains albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta 2-adrenergic bronchodilator. Albuterol sulfate has the chemical name α 1-[( tert-butylamino)methyl]-4-hydroxy- m-xylene-α,α'-diolsulfate (2:1) (salt) and the following chemical structure:. (C 13H 21NO 3) 2H 2SO 4 M.W. 576.7. Albuterol sulfate is a white or practically white powder freely soluble in water and slightly soluble in alcohol, in chloroform, and in ether per USP definition. The World Health Organization recommended name for albuterol base is salbutamol. Albuterol Sulfate Syrup for oral administration contains 2 mg of albuterol as 2.4 mg of albuterol sulfate in each teaspoonful (5 mL). Albuterol Sulfate Syrup also contains the inactive ingredients Purified water, hypromellose, citric acid anhydrous, sodium citrate dihydrate, sodium benzoate, sorbitol solution, strawberry flavor, and FD&C Yellow # 6. The pH of the syrup is 3.2 to 4.2.</Description>
</NDC>
<NDC>
<NDCCode>62135-196-24</NDCCode>
<PackageDescription>2 TRAY in 1 BOX (62135-196-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-196-45) </PackageDescription>
<NDC11Code>62135-0196-24</NDC11Code>
<ProductNDC>62135-196</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valproic Acid</ProprietaryName>
<NonProprietaryName>Valproic Acid</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20001222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075782</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>VALPROIC ACID</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240528</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valproic acid oral solution is indicated for: 1 Monotherapy and adjunctive therapy of complex partial seizures; sole and adjunctive therapy of simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures ( 1) .</IndicationAndUsage>
<Description>Valproic acid is a carboxylic acid designated as 2-propylpentanoic acid. It is also known as dipropylacetic acid. Valproic acid has the following structure. Valproic acid (pKa 4.8) has a molecular weight of 144 and occurs as a colorless liquid with a characteristic odor. It is slightly soluble in water (1.3 mg/mL) and very soluble in organic solvents. Valproic acid oral solution, USP is an antiepileptic for oral administration. The oral solution contains the equivalent of 250 mg valproic acid per 5 mL as the sodium salt. Inactive Ingredients. Oral Solution: Glycerin, methylparaben, propylparaben, sodium hydroxide, sorbitol, sucrose, purified water, FD&C Red No. 40 and flavor wild cherry.</Description>
</NDC>
</NDCList>