{
"NDC": [
{
"NDCCode": "71205-512-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (71205-512-60) ",
"NDC11Code": "71205-0512-60",
"ProductNDC": "71205-512",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levothyroxine Sodium",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200803",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021342",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "25",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Active",
"LastUpdate": "2022-04-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201202",
"SamplePackage": "N",
"IndicationAndUsage": "Hypothyroidism. Levothyroxine sodium tablets are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary) and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression. Levothyroxine sodium tablets are indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium tablets may induce hyperthyroidism [see Warnings and Precautions (5.4)]. Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.",
"Description": "Levothyroxine sodium tablets, USP contain synthetic crystalline L-3,3',5,5'- tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4NNaO4 xH2O (where x = 5), molecular weight of 798.86 g/mol (anhydrous) and structural formula as shown:. Levothyroxine sodium tablets for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients Magnesium Stearate, NF; Microcrystalline Cellulose, NF; Colloidal Silicone Dioxide, NF; and Sodium Starch Glycolate, NF. Each tablet strength meets USP Dissolution Test 2. Table 6 provides a listing of the color additives by tablet strength:. Table 6. Levothyroxine Sodium Tablets Color Additives."
},
{
"NDCCode": "71205-512-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (71205-512-30) ",
"NDC11Code": "71205-0512-30",
"ProductNDC": "71205-512",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levothyroxine Sodium",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200803",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021342",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "25",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Active",
"LastUpdate": "2022-04-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201202",
"SamplePackage": "N",
"IndicationAndUsage": "Hypothyroidism. Levothyroxine sodium tablets are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary) and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression. Levothyroxine sodium tablets are indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium tablets may induce hyperthyroidism [see Warnings and Precautions (5.4)]. Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.",
"Description": "Levothyroxine sodium tablets, USP contain synthetic crystalline L-3,3',5,5'- tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4NNaO4 xH2O (where x = 5), molecular weight of 798.86 g/mol (anhydrous) and structural formula as shown:. Levothyroxine sodium tablets for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients Magnesium Stearate, NF; Microcrystalline Cellulose, NF; Colloidal Silicone Dioxide, NF; and Sodium Starch Glycolate, NF. Each tablet strength meets USP Dissolution Test 2. Table 6 provides a listing of the color additives by tablet strength:. Table 6. Levothyroxine Sodium Tablets Color Additives."
},
{
"NDCCode": "71205-512-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (71205-512-90) ",
"NDC11Code": "71205-0512-90",
"ProductNDC": "71205-512",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levothyroxine Sodium",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200803",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021342",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "25",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Active",
"LastUpdate": "2022-04-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201202",
"SamplePackage": "N",
"IndicationAndUsage": "Hypothyroidism. Levothyroxine sodium tablets are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary) and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression. Levothyroxine sodium tablets are indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium tablets may induce hyperthyroidism [see Warnings and Precautions (5.4)]. Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.",
"Description": "Levothyroxine sodium tablets, USP contain synthetic crystalline L-3,3',5,5'- tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4NNaO4 xH2O (where x = 5), molecular weight of 798.86 g/mol (anhydrous) and structural formula as shown:. Levothyroxine sodium tablets for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients Magnesium Stearate, NF; Microcrystalline Cellulose, NF; Colloidal Silicone Dioxide, NF; and Sodium Starch Glycolate, NF. Each tablet strength meets USP Dissolution Test 2. Table 6 provides a listing of the color additives by tablet strength:. Table 6. Levothyroxine Sodium Tablets Color Additives."
},
{
"NDCCode": "35356-512-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (35356-512-60) ",
"NDC11Code": "35356-0512-60",
"ProductNDC": "35356-512",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol",
"NonProprietaryName": "Carvedilol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070905",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078251",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "CARVEDILOL",
"StrengthNumber": "6.25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20070905",
"SamplePackage": "N",
"IndicationAndUsage": "Carvedilol tablets USP are an alpha/beta-adrenergic blocking agent indicated for the treatment of: 1 Left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2) , 2 Hypertension (1.3) .",
"Description": "Carvedilol, USP is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol, USP is a racemic mixture with the following structure. Carvedilol tablets USP are film-coated tablets containing 3.125 mg, 6.25 mg, 12.5 mg or 25 mg of carvedilol. The 3.125 mg, 6.25 mg and 25 mg tablets are white film coated circular shaped tablets. The 12.5 mg tablets are white film coated capsule shaped tablets. Inactive ingredients consist of colloidal silicon dioxide, crospovidone, hypromellose, lactose, magnesium stearate, polyethylene glycol, polysorbate 80, povidone and titanium dioxide. Carvedilol, USP is a white to off-white powder with a molecular weight of 406.5 and a molecular formula of C24H26N2O4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5). The product meets USP Dissolution test 2."
},
{
"NDCCode": "42291-512-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (42291-512-60) ",
"NDC11Code": "42291-0512-60",
"ProductNDC": "42291-512",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pioglitazone And Metformin Hydrochloride",
"NonProprietaryName": "Pioglitazone And Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150306",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091155",
"LabelerName": "AvKARE, Inc.",
"SubstanceName": "PIOGLITAZONE HYDROCHLORIDE; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "15; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [CS],PPAR gamma [CS],Thiazolidinedione [EPC],Thiazolidinediones [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Biguanide [EPC],Biguanides [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-04-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20150306",
"SamplePackage": "N"
},
{
"NDCCode": "42508-512-07",
"PackageDescription": "1 KIT in 1 CARTON (42508-512-07) * 60 mL in 1 TUBE * 57 g in 1 TUBE",
"NDC11Code": "42508-0512-07",
"ProductNDC": "42508-512",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Abc Arbonne Baby Care Little Bundles Set",
"NonProprietaryName": "Dimethicone And Zinc Oxide",
"DosageFormName": "KIT",
"StartMarketingDate": "20150901",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Arbonne International, LLC",
"Status": "Deprecated",
"LastUpdate": "2018-12-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "42549-512-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (42549-512-60)",
"NDC11Code": "42549-0512-60",
"ProductNDC": "42549-512",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20091124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078428",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Postherpetic Neuralgia. Gabapentin Capsules is indicated for the management of postherpetic neuralgia in adults. Epilepsy. Gabapentin Capsules is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in patients over 12 years of age with epilepsy. Gabapentin Capsules is also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 – 12 years.",
"Description": "Gabapentin Capsules are supplied as imprinted hard shell capsules containing 100 mg, 300 mg, and 400 mg of gabapentin. The inactive ingredients for the capsules are magnesium stearate, pregelatinized starch, starch and talc. The 100 mg capsule shell contains gelatin, sodium lauryl sulfate and titanium dioxide. The 300 mg capsule shell contains gelatin, sodium lauryl sulfate, titanium dioxide, and iron oxide yellow. The 400 mg capsule shell contains gelatin, sodium lauryl sulfate, titanium dioxide, FD&C Yellow No.6 and FD&C Blue No.1. Gabapentin is described as 1-(aminomethyl)cyclohexaneacetic acid with a molecular formula of C9H17NO2 and a molecular weight of 171.24. The structural formula of gabapentin is. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. 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 –1.25."
},
{
"NDCCode": "43063-512-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (43063-512-60) ",
"NDC11Code": "43063-0512-60",
"ProductNDC": "43063-512",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20131018",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091393",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20140508",
"SamplePackage": "N"
},
{
"NDCCode": "43333-512-60",
"PackageDescription": ".1 mL in 1 POUCH (43333-512-60) ",
"NDC11Code": "43333-0512-60",
"ProductNDC": "43333-512",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antibacterial Wipes",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "SWAB",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200902",
"EndMarketingDate": "20220902",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Tonic Bath & Body Products Shenzhen Ltd",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".1",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2022-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200902",
"EndMarketingDatePackage": "20220902",
"SamplePackage": "N"
},
{
"NDCCode": "51862-512-60",
"PackageDescription": "1 CAN in 1 CARTON (51862-512-60) / 60 g in 1 CAN",
"NDC11Code": "51862-0512-60",
"ProductNDC": "51862-512",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Calcipotriene",
"NonProprietaryName": "Calcipotriene",
"DosageFormName": "AEROSOL, FOAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210215",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022563",
"LabelerName": "Mayne Pharma",
"SubstanceName": "CALCIPOTRIENE",
"StrengthNumber": "50",
"StrengthUnit": "ug/g",
"Pharm_Classes": "Vitamin D Analog [EPC], Vitamin D [CS]",
"Status": "Active",
"LastUpdate": "2024-05-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210215",
"SamplePackage": "N",
"IndicationAndUsage": "Calcipotriene foam is indicated for the topical treatment of plaque psoriasis of the scalp and body in adults and pediatric patients 4 years of age and older.",
"Description": "Calcipotriene foam contains the compound calcipotriene, a synthetic vitamin D3 analog, in an aqueous-based emulsion foam vehicle for topical dermatologic use. Chemically, calcipotriene is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19), 22-tetraene- 1α,3β,24-triol. The structural formula is represented below. Molecular Formula: C27H40O3 Molecular Weight: 412.6. Calcipotriene is a white or off-white crystalline substance. Calcipotriene foam contains calcipotriene 50 mcg/g in an aqueous-based emulsion foam vehicle consisting of cetyl alcohol, dibasic sodium phosphate, dl-α-tocopherol, edetate disodium, isopropyl myristate, light mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, stearyl alcohol, and white petrolatum. Calcipotriene foam is dispensed from an aluminum can pressurized with a hydrocarbon (propane/n-butane/isobutane) propellant."
},
{
"NDCCode": "52959-512-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (52959-512-60)",
"NDC11Code": "52959-0512-60",
"ProductNDC": "52959-512",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketorolac Tromethamine",
"NonProprietaryName": "Ketorolac Tromethamine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20100420",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074754",
"LabelerName": "H.J. Harkins Company, Inc.",
"SubstanceName": "KETOROLAC TROMETHAMINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac tromethamine. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.",
"Description": "Ketorolac tromethamine is a member of the pyrrolo-pyrrole group of non-steroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is (±)-5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol. The structural formula is. C19H24N2O6 M.W. 376.41. Ketorolac tromethamine is a racemic mixture of [-]S and [+]R ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26. Ketorolac tromethamine tablets are round, white, unscored, film-coated tablets. Each tablet, for oral administration, contains 10 mg ketorolac tromethamine, the active ingredient. In addition, each tablet contains the following inactive ingredients: hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide."
},
{
"NDCCode": "55513-512-60",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (55513-512-60) / 120 TABLET, COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "55513-0512-60",
"ProductNDC": "55513-512",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lumakras",
"NonProprietaryName": "Sotorasib",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240627",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA214665",
"LabelerName": "Amgen Inc",
"SubstanceName": "SOTORASIB",
"StrengthNumber": "240",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240627",
"SamplePackage": "N",
"IndicationAndUsage": "LUMAKRAS is an inhibitor of the RAS GTPase family indicated for. KRAS G12C-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC): 1 As a single agent, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. (1.1).",
"Description": "Sotorasib is an inhibitor of the RAS GTPase family. The molecular formula is C30H30F2N6O3, and the molecular weight is 560.6 g/mol. The chemical name of sotorasib is 6-fluoro-7-(2-fluoro-6-hydroxyphenyl)-(1M)-1-[4-methyl-2-(propan-2-yl)pyridin-3-yl]-4-[(2S)-2-methyl-4-(prop-2-enoyl)piperazin-1-yl]pyrido[2,3-d]pyrimidin-2(1H)-one. The chemical structure of sotorasib is shown below. Sotorasib has pKa values of 8.06 and 4.56. The solubility of sotorasib in the aqueous media decreases over the range pH 1.2 to 6.8 from 1.3 mg/mL to 0.03 mg/mL. LUMAKRAS is supplied as film-coated tablets for oral use containing 320 mg, 240 mg or 120 mg of sotorasib. Inactive ingredients in the tablet core are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, and magnesium stearate. The film coating material consists of polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow and iron oxide red (320 mg tablet only)."
},
{
"NDCCode": "63187-512-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (63187-512-60) ",
"NDC11Code": "63187-0512-60",
"ProductNDC": "63187-512",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phentermine Hydrochloride",
"NonProprietaryName": "Phentermine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20120807",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040886",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "PHENTERMINE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2020-03-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170501",
"SamplePackage": "N",
"IndicationAndUsage": "Phentermine Hydrochloride, USP 15 mg and 30 mg is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥30 kg/m2, or≥27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. The limited usefulness of agents of this class, including Phentermine hydrochloride, [see CLINICAL PHARMACOLOGY (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.",
"Description": "Phentermine Hydrochloride USP has the chemical name of α, α -Dimethylphenethylamine hydrochloride. The structural formula is as follows. Phentermine Hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols; slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride, an anorectic agent for oral administration, is available as. a) powder-filled capsules containing 15 mg Phentermine hydrochloride (equivalent to 12 mg Phentermine) or 30 mg Phentermine hydrochloride (equivalent to 24 mg Phentermine) and inactive ingredients: corn starch, gelatin, lactose monohydrate and magnesium stearate. In addition, the 15 mg capsules contain D&C Yellow #10, FD&C Blue #1, FD&C Red #3, FD&C Red #40, titanium dioxide and the 30 mg capsules contain D&C Yellow #10, FD&C Red #3, titanium dioxide. b) bead-filled capsules containing 30 mg Phentermine hydrochloride (equivalent to 24 mg Phentermine) and inactive ingredients: corn starch, sucrose, hypromellose, povidone, and talc. In addition, the capsule contains FD&C blue #1/Brilliant blue FCF Aluminum Lake, D&C red #28 and gelatin."
},
{
"NDCCode": "68001-512-06",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68001-512-06) ",
"NDC11Code": "68001-0512-06",
"ProductNDC": "68001-512",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine Fumarate",
"NonProprietaryName": "Quetiapine Fumarate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20210831",
"EndMarketingDate": "20250331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090681",
"LabelerName": "Bluepoint Laboratories",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210831",
"EndMarketingDatePackage": "20250331",
"SamplePackage": "N",
"IndicationAndUsage": "Quetiapine Extended-release tablet is an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder, manic, or mixed episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2), 4 Major depressive disorder, adjunctive therapy with antidepressants (1.3).",
"Description": "Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [ b,f ] [1,4] thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C 42H 50N 6O 4S 2C 4H 4O 4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is:. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine Extended-release tablets, USP are supplied for oral administration as 150 mg (white), 200 mg (yellow), 300 mg (light yellow), and 400 mg (white). All tablets are round shaped and film coated. Inactive ingredients for quetiapine extended-release tablets, USP are lactose monohydrate, sodium chloride, hydroxypropyl methylcellulose, povidone K30, talc and magnesium stearate. The film coating for all quetiapine extended-release tablets contain hypromellose, polyethylene glycol 400 and titanium dioxide. In addition, iron oxide yellow (200 and 300 mg tablets) is included in the film coating of specific strengths. Each 150 mg tablet contains 173 mg of quetiapine fumarate, USP equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230 mg of quetiapine fumarate, USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345 mg of quetiapine fumarate, USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 461 mg of quetiapine fumarate, USP equivalent to 400 mg quetiapine. Quetiapine Extended-release tablets, USP meet USP Dissolution Test 2."
},
{
"NDCCode": "70204-512-01",
"PackageDescription": "60 mL in 1 BOTTLE (70204-512-01) ",
"NDC11Code": "70204-0512-01",
"ProductNDC": "70204-512",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antibacterial Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200501",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Hit Promotional Products, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "68",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-01-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200501",
"SamplePackage": "N"
},
{
"NDCCode": "70868-510-30",
"PackageDescription": "1 KIT in 1 CARTON (70868-510-30) * 60 CAPSULE in 1 BOTTLE (70868-512-30) * 90 CAPSULE in 1 BOTTLE (70868-513-30) * 30 TABLET in 1 BOTTLE (70868-511-30) ",
"NDC11Code": "70868-0510-30",
"ProductNDC": "70868-510",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Accentrate Pnv",
"NonProprietaryName": "Prenatal Multivitamin Tablet And Combination Omega-3 Softgel/mineral Capsule",
"DosageFormName": "KIT",
"RouteName": "ORAL",
"StartMarketingDate": "20250217",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Key Therapeutics",
"Status": "Active",
"LastUpdate": "2025-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250225",
"SamplePackage": "N",
"IndicationAndUsage": "Accentrate® PNV (Folate/Omega-3/Iron) (6 mg-210 mg-10 mg) is a Prescription Prenatal Multivitamin Tablet and combination Omega-3 Softgel/Mineral Capsule indicated for preventing neural tube defects and use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers.",
"Description": "Accentrate® PNV (Folate/Omega-3/Iron) (6 mg-210 mg-10 mg) is an orally administered Prescription Prenatal Multivitamin Tablet and combination Omega-3 Softgel/Mineral Capsule. Accentrate® PNV contains a prenatal tablet, omega-3 softgels, and mineral capsules. Each one tablet contains 6 mg of L-methylfolate Calcium, each two softgel serving contains 210 mg of EPA and DHA, and each three capsule serving contain 10 mg of iron. Each prenatal tablet contains:. Each two omega-3 softgel serving contains:. CONTAINS: Shellfish (Krill). Each three mineral capsule serving contains:."
},
{
"NDCCode": "70934-512-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (70934-512-60) ",
"NDC11Code": "70934-0512-60",
"ProductNDC": "70934-512",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200122",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074891",
"LabelerName": "Denton Pharma, Inc. dba Northwind Pharmaceuticals",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200122",
"SamplePackage": "N"
},
{
"NDCCode": "71610-512-60",
"PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-512-60) ",
"NDC11Code": "71610-0512-60",
"ProductNDC": "71610-512",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200831",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA019962",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "METOPROLOL SUCCINATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-06-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210104",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol Succinate is a beta1-selective adrenoceptor blocking agent. Metoprolol Succinate is indicated for the treatment of: : 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Angina Pectoris. (1.2), 3 Heart Failure - for the treatment of stable, symptomatic (NYHA Class II or III) heart failure of ischemic, hypertensive, or cardiomyopathic origin. (1.3).",
"Description": "Metoprolol succinate, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablet has been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: silicon dioxide, cellulose compounds, sodium stearyl fumarate, polyethylene glycol, titanium dioxide, paraffin."
},
{
"NDCCode": "72789-512-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (72789-512-60) ",
"NDC11Code": "72789-0512-60",
"ProductNDC": "72789-512",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrochlorothiazide",
"NonProprietaryName": "Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19730112",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA083177",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "HYDROCHLOROTHIAZIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251029",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide tablets are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.",
"Description": "Hydrochlorothiazide, USP is a diuretic and antihypertensive. It is the 3,4-dihydro derivative of chlorothiazide. It is chemically designated as 6-chloro-3,4-dihydro-2 H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide and has the following structural formula:. C 7H 8ClN 3O 4S 2 M.W. 297.74. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder which is slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids. Each tablet for oral administration contains 25 mg or 50 mg hydrochlorothiazide, USP. In addition, each tablet contains the following inactive ingredients: corn starch, dibasic calcium phosphate dihydrate, FD&C Yellow No. 6 Aluminum Lake, lactose monohydrate and magnesium stearate."
},
{
"NDCCode": "76420-512-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (76420-512-60) ",
"NDC11Code": "76420-0512-60",
"ProductNDC": "76420-512",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine",
"NonProprietaryName": "Quetiapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201504",
"LabelerName": "ASCLEMED USA INC.",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251021",
"SamplePackage": "N",
"IndicationAndUsage": "Quetiapine is an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia ( 1.1) , 2 Bipolar I disorder manic episodes ( 1.2) , 3 Bipolar disorder, depressive episodes ( 1.2) .",
"Description": "Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [ b,f] [1,4]thiazepin-11-yl-1-piperazinyl) ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C 42H 50N 6O 4S 2C 4H 4O 4and it has a molecular weight of 883.11 (fumarate salt). The structural formula is:. Quetiapine fumarate USP is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablets, USP is supplied for oral administration as 25 mg (round peach), 50 mg (round, white), 100 mg (round yellow), 150 mg (round, off white to light yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are povidone, dibasic dicalcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, hypromellose, polyethylene glycol and titanium dioxide. The 25 mg tablets contain red iron oxide and yellow iron oxide and the 100 mg, 150 mg and 400 mg tablets contain only yellow iron oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate USP equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate USP equivalent to 100 mg quetiapine. Each 150 mg tablet contains 172.70 mg of quetiapine fumarate USP equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.27 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.40 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.54 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine."
},
{
"NDCCode": "77610-512-01",
"PackageDescription": "60 mL in 1 BOTTLE, PUMP (77610-512-01) ",
"NDC11Code": "77610-0512-01",
"ProductNDC": "77610-512",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200511",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "IMKOR LIMITED LIABILITY COMPANY",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200511",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "0591-4575-60",
"PackageDescription": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (0591-4575-60) ",
"NDC11Code": "00591-4575-60",
"ProductNDC": "0591-4575",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190814",
"EndMarketingDate": "20270630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090134",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2026-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190814",
"EndMarketingDatePackage": "20270630",
"SamplePackage": "N",
"IndicationAndUsage": "Doxycycline hyclate delayed-release tablets are a tetracycline-class drug indicated for: 1 Rickettsial infections (1.1) , 2 Sexually transmitted infections (1.2) , 3 Respiratory tract infections (1.3) , 4 Specific bacterial infections (1.4) , 5 Ophthalmic infections (1.5) , 6 Anthrax, including inhalational anthrax (post-exposure) (1.6) , 7 Alternative treatment for selected infections when penicillin is contraindicated (1.7) , 8 Adjunctive therapy in acute intestinal amebiasis and severe acne (1.8) , 9 Prophylaxis of malaria (1.9).",
"Description": "Doxycycline hyclate delayed-release tablets USP, for oral administration, contain specially coated pellets of doxycycline hyclate, USP, a tetracycline class drug synthetically derived from oxytetracycline, in a delayed-release formulation for oral administration. The structural formula for doxycycline hyclate, USP is. The molecular formula is C22H24N2O8 HCl ½ C2H6O ½ H2O and a molecular weight of 512.9. The chemical name for doxycycline hyclate, USP is 4-(dimethylamino)-1,4,4α,5,5α,6,11,12α-octahydro-3,5,10,12, 12α-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacencarboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline hyclate, USP is a yellow crystalline powder soluble in water and in solutions of alkali hydroxides and carbonates. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each tablet contains doxycycline 50 mg or 200 mg equivalent to doxycycline hyclate 57.7 mg or 230.8 mg, respectively. Inactive ingredients in the tablet formulation are: crospovidone, D&C Yellow #10 Aluminum Lake, hypromellose 2910, hypromellose phthalate, magnesium stearate, mannitol, microcrystalline cellulose, povidone, silicified microcrystalline cellulose, talc, and triethyl citrate. USP Dissolution test pending."
},
{
"NDCCode": "23155-141-06",
"PackageDescription": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (23155-141-06) ",
"NDC11Code": "23155-0141-06",
"ProductNDC": "23155-141",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"ProprietaryNameSuffix": "Delayed Release",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200856",
"LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2025-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130430",
"SamplePackage": "N",
"IndicationAndUsage": "Doxycycline hyclate delayed-release tablets are a tetracycline-class drug indicated for: Rickettsial infections (1.1) Sexually transmitted infections (1.2) Respiratory tract infections (1.3) Specific bacterial infections (1.4) Ophthalmic infections (1.5) Anthrax, including inhalational anthrax (post-exposure) (1.6) Alternative treatment for selected infections when penicillin is contraindicated (1.7) Adjunctive therapy in acute intestinal amebiasis and severe acne (1.8) Prophylaxis of malaria (1.9). UsageTo reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate delayed-release tablets, should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.10).",
"Description": "Doxycycline hyclate delayed-release tablets, USP, contain specially coated pellets of doxycycline hyclate, a tetracycline class drug synthetically derived from oxytetracycline, in a delayed-release formulation for oral administration. The structural formula for doxycycline hyclate is. with a molecular formula of C22H24N2O8, HCl, ½ C2H6O, ½ H2O and a molecular weight of 512.9. The chemical name for doxycycline hyclate is [4S(4aR,5S,5aR,6R,12aS)]-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-deoxonaphthacene-2-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline hyclate is a yellow crystalline powder soluble in water and in solutions of alkali hydroxides and carbonates. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each tablet contains doxycycline 75 mg, 100 mg, 150 mg or 200 mg (equivalent to doxycycline hyclate 86.6 mg, 115.4 mg, 173.1 mg or 230.8 mg). Inactive ingredients in the tablet formulation are: lactose monohydrate, microcrystalline cellulose; sodium lauryl sulfate, sodium chloride, hypromellose phthalate, hypromellose, triethyl citrate, anhydrous lactose, crospovidone, stearic acid, magnesium stearate. The tablets also contain opadry 03K29121 clear, which contains: hypromellose and triacetin. Each doxycycline hyclate delayed-release tablets 75 mg tablet contains 4.8 mg (0.208 mEq) of sodium, each doxycycline hyclate delayed-release tablets 100 mg tablet contains 6.4 mg (0.278 mEq) of sodium, each doxycycline hyclate delayed-release tablets 150 mg tablet contains 9.6 mg (0.417 mEq) of sodium, and each doxycycline hyclate delayed-release tablets 200 mg tablet contains 12.8 mg (0.556 mEq) of sodium. USP dissolution test pending."
},
{
"NDCCode": "23155-143-06",
"PackageDescription": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (23155-143-06) ",
"NDC11Code": "23155-0143-06",
"ProductNDC": "23155-143",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"ProprietaryNameSuffix": "Delayed Release",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200856",
"LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2025-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130430",
"SamplePackage": "N",
"IndicationAndUsage": "Doxycycline hyclate delayed-release tablets are a tetracycline-class drug indicated for: Rickettsial infections (1.1) Sexually transmitted infections (1.2) Respiratory tract infections (1.3) Specific bacterial infections (1.4) Ophthalmic infections (1.5) Anthrax, including inhalational anthrax (post-exposure) (1.6) Alternative treatment for selected infections when penicillin is contraindicated (1.7) Adjunctive therapy in acute intestinal amebiasis and severe acne (1.8) Prophylaxis of malaria (1.9). UsageTo reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate delayed-release tablets, should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.10).",
"Description": "Doxycycline hyclate delayed-release tablets, USP, contain specially coated pellets of doxycycline hyclate, a tetracycline class drug synthetically derived from oxytetracycline, in a delayed-release formulation for oral administration. The structural formula for doxycycline hyclate is. with a molecular formula of C22H24N2O8, HCl, ½ C2H6O, ½ H2O and a molecular weight of 512.9. The chemical name for doxycycline hyclate is [4S(4aR,5S,5aR,6R,12aS)]-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-deoxonaphthacene-2-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline hyclate is a yellow crystalline powder soluble in water and in solutions of alkali hydroxides and carbonates. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each tablet contains doxycycline 75 mg, 100 mg, 150 mg or 200 mg (equivalent to doxycycline hyclate 86.6 mg, 115.4 mg, 173.1 mg or 230.8 mg). Inactive ingredients in the tablet formulation are: lactose monohydrate, microcrystalline cellulose; sodium lauryl sulfate, sodium chloride, hypromellose phthalate, hypromellose, triethyl citrate, anhydrous lactose, crospovidone, stearic acid, magnesium stearate. The tablets also contain opadry 03K29121 clear, which contains: hypromellose and triacetin. Each doxycycline hyclate delayed-release tablets 75 mg tablet contains 4.8 mg (0.208 mEq) of sodium, each doxycycline hyclate delayed-release tablets 100 mg tablet contains 6.4 mg (0.278 mEq) of sodium, each doxycycline hyclate delayed-release tablets 150 mg tablet contains 9.6 mg (0.417 mEq) of sodium, and each doxycycline hyclate delayed-release tablets 200 mg tablet contains 12.8 mg (0.556 mEq) of sodium. USP dissolution test pending."
},
{
"NDCCode": "23155-611-06",
"PackageDescription": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (23155-611-06) ",
"NDC11Code": "23155-0611-06",
"ProductNDC": "23155-611",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"ProprietaryNameSuffix": "Delayed Release",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180316",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200856",
"LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2025-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180316",
"SamplePackage": "N",
"IndicationAndUsage": "Doxycycline hyclate delayed-release tablets are a tetracycline-class drug indicated for: Rickettsial infections (1.1) Sexually transmitted infections (1.2) Respiratory tract infections (1.3) Specific bacterial infections (1.4) Ophthalmic infections (1.5) Anthrax, including inhalational anthrax (post-exposure) (1.6) Alternative treatment for selected infections when penicillin is contraindicated (1.7) Adjunctive therapy in acute intestinal amebiasis and severe acne (1.8) Prophylaxis of malaria (1.9). UsageTo reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate delayed-release tablets, should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.10).",
"Description": "Doxycycline hyclate delayed-release tablets, USP, contain specially coated pellets of doxycycline hyclate, a tetracycline class drug synthetically derived from oxytetracycline, in a delayed-release formulation for oral administration. The structural formula for doxycycline hyclate is. with a molecular formula of C22H24N2O8, HCl, ½ C2H6O, ½ H2O and a molecular weight of 512.9. The chemical name for doxycycline hyclate is [4S(4aR,5S,5aR,6R,12aS)]-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-deoxonaphthacene-2-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline hyclate is a yellow crystalline powder soluble in water and in solutions of alkali hydroxides and carbonates. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each tablet contains doxycycline 75 mg, 100 mg, 150 mg or 200 mg (equivalent to doxycycline hyclate 86.6 mg, 115.4 mg, 173.1 mg or 230.8 mg). Inactive ingredients in the tablet formulation are: lactose monohydrate, microcrystalline cellulose; sodium lauryl sulfate, sodium chloride, hypromellose phthalate, hypromellose, triethyl citrate, anhydrous lactose, crospovidone, stearic acid, magnesium stearate. The tablets also contain opadry 03K29121 clear, which contains: hypromellose and triacetin. Each doxycycline hyclate delayed-release tablets 75 mg tablet contains 4.8 mg (0.208 mEq) of sodium, each doxycycline hyclate delayed-release tablets 100 mg tablet contains 6.4 mg (0.278 mEq) of sodium, each doxycycline hyclate delayed-release tablets 150 mg tablet contains 9.6 mg (0.417 mEq) of sodium, and each doxycycline hyclate delayed-release tablets 200 mg tablet contains 12.8 mg (0.556 mEq) of sodium. USP dissolution test pending."
},
{
"NDCCode": "33358-512-30",
"PackageDescription": "30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (33358-512-30)",
"NDC11Code": "33358-0512-30",
"ProductNDC": "33358-512",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron",
"NonProprietaryName": "Ondansetron",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20141202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090469",
"LabelerName": "RxChange Co.",
"SubstanceName": "ONDANSETRON",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"Description": "The active ingredient in ondansetron orally disintegrating tablets, USP is ondansetron base, the racemic form of ondansetron, and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one. It has the following structural formula. The molecular formula is C18H19N3O representing a molecular weight of 293.4. Ondansetron is a white to off-white powder.Each 4 mg ondansetron orally disintegrating tablet, USP for oral administration contains 4 mg ondansetron base. Each 8 mg ondansetron orally disintegrating tablet, USP for oral administration contains 8 mg ondansetron base. Each ondansetron orally disintegrating tablet also contains the inactive ingredients mannitol, crospovidone, lactose monohydrate, microcrystalline cellulose, aspartame, strawberry guarana flavor, colloidal silicon dioxide, and magnesium stearate. The strawberry guarana flavor contains maltodextrin, propylene glycol, artificial flavors, and acetic acid. Ondansetron orally disintegrating tablets, USP are orally administered formulation of ondansetron which rapidly disintegrates on the tongue and does not require water to aid dissolution or swallowing.This product does not meet USP Disintegration Time. The 4 mg and 8 mg tablets disintegrate in approximately 60 seconds."
},
{
"NDCCode": "43547-324-06",
"PackageDescription": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (43547-324-06) ",
"NDC11Code": "43547-0324-06",
"ProductNDC": "43547-324",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20161128",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207494",
"LabelerName": "Solco Healthcare US LLC",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20161128",
"SamplePackage": "N",
"IndicationAndUsage": "Doxycycline hyclate delayed-release tablets are a tetracycline-class drug indicated for: 1 Rickettsial infections (1.1), 2 Sexually transmitted infections (1.2), 3 Respiratory tract infections (1.3), 4 Specific bacterial infections (1.4), 5 Ophthalmic infections (1.5), 6 Anthrax, including inhalational anthrax (post-exposure) (1.6), 7 Alternative treatment for selected infections when penicillin is contraindicated (1.7), 8 Adjunctive therapy in acute intestinal amebiasis and severe acne (1.8), 9 Prophylaxis of malaria (1.9).",
"Description": "Doxycycline hyclate delayed-release tablets, contain specially coated pellets of doxycycline hyclate, USP, a tetracycline class drug synthetically derived from oxytetracycline, in a delayed-release formulation for oral administration. The structural formula for doxycycline hyclate is. with a molecular formula of C22H24N2O8, HCl, ½ C2H6O, ½ H2O and a molecular weight of 512.9. The chemical name for doxycycline hyclate is [4S(4aR,5S,5aR,6R,12aS)]-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-deoxonapthtacene-2-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline hyclate is a yellow crystalline powder soluble in water and in solutions of alkali hydroxides and carbonates. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Inactive ingredients in the tablet formulation are: crospovidone; hypromellose; hypromellose phthalate; lactose monohydrate; magnesium stearate; mannitol; microcrystalline cellulose; povidone; sodium chloride; sodium lauryl sulfate; talc; triethyl citrate. Meets USP Dissolution Test 3."
},
{
"NDCCode": "43547-325-06",
"PackageDescription": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (43547-325-06) ",
"NDC11Code": "43547-0325-06",
"ProductNDC": "43547-325",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20161128",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207494",
"LabelerName": "Solco Healthcare US LLC",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20161128",
"SamplePackage": "N",
"IndicationAndUsage": "Doxycycline hyclate delayed-release tablets are a tetracycline-class drug indicated for: 1 Rickettsial infections (1.1), 2 Sexually transmitted infections (1.2), 3 Respiratory tract infections (1.3), 4 Specific bacterial infections (1.4), 5 Ophthalmic infections (1.5), 6 Anthrax, including inhalational anthrax (post-exposure) (1.6), 7 Alternative treatment for selected infections when penicillin is contraindicated (1.7), 8 Adjunctive therapy in acute intestinal amebiasis and severe acne (1.8), 9 Prophylaxis of malaria (1.9).",
"Description": "Doxycycline hyclate delayed-release tablets, contain specially coated pellets of doxycycline hyclate, USP, a tetracycline class drug synthetically derived from oxytetracycline, in a delayed-release formulation for oral administration. The structural formula for doxycycline hyclate is. with a molecular formula of C22H24N2O8, HCl, ½ C2H6O, ½ H2O and a molecular weight of 512.9. The chemical name for doxycycline hyclate is [4S(4aR,5S,5aR,6R,12aS)]-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-deoxonapthtacene-2-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline hyclate is a yellow crystalline powder soluble in water and in solutions of alkali hydroxides and carbonates. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Inactive ingredients in the tablet formulation are: crospovidone; hypromellose; hypromellose phthalate; lactose monohydrate; magnesium stearate; mannitol; microcrystalline cellulose; povidone; sodium chloride; sodium lauryl sulfate; talc; triethyl citrate. Meets USP Dissolution Test 3."
},
{
"NDCCode": "46708-481-60",
"PackageDescription": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (46708-481-60) ",
"NDC11Code": "46708-0481-60",
"ProductNDC": "46708-481",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220104",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213075",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2023-04-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220104",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate delayed-release tablets and other antibacterial drugs, doxycycline hyclate delayed-release tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Doxycycline is a tetracycline-class antibacterial indicated in the following conditions or disease.",
"Description": "Doxycycline hyclate delayed-release tablets, USP for oral administration, contain specially coated pellets of doxycycline hyclate, USP, a broad-spectrum antibacterial synthetically derived from oxytetracycline, in a delayed-release formulation for oral administration.The structural formula for doxycycline hyclate, USP is. with a molecular formula of C22H24N2O8, HCl, ½ C2H6O, ½ H2O and a molecular weight of 512.9. The chemical designation for doxycycline hyclate is [4S(4aR,5S,5aR,6R,12aS)]-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-deoxonaphthacene-2-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline hyclate, USP is a yellow to light yellow powder, freely soluble in water and in methanol; sparingly soluble in alcohol; practically insoluble in chloroform and in ether. It dissolves in aqueous solutions of alkali hydroxides and carbonates. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Inactive ingredients in the tablet formulation are: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, sodium chloride, povidone (K-30), hypromellose, talc, hypromellose phthalate, triethyl citrate, polyethylene glycol 6000, corn starch, lactose anhydrous, low substituted hydroxypropyl cellulose, crospovidone, colloidal silicon dioxide and magnesium stearate. This drug product meets USP Dissolution Test 5."
},
{
"NDCCode": "46708-482-60",
"PackageDescription": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (46708-482-60) ",
"NDC11Code": "46708-0482-60",
"ProductNDC": "46708-482",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220104",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213075",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2023-04-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220104",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate delayed-release tablets and other antibacterial drugs, doxycycline hyclate delayed-release tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Doxycycline is a tetracycline-class antibacterial indicated in the following conditions or disease.",
"Description": "Doxycycline hyclate delayed-release tablets, USP for oral administration, contain specially coated pellets of doxycycline hyclate, USP, a broad-spectrum antibacterial synthetically derived from oxytetracycline, in a delayed-release formulation for oral administration.The structural formula for doxycycline hyclate, USP is. with a molecular formula of C22H24N2O8, HCl, ½ C2H6O, ½ H2O and a molecular weight of 512.9. The chemical designation for doxycycline hyclate is [4S(4aR,5S,5aR,6R,12aS)]-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-deoxonaphthacene-2-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline hyclate, USP is a yellow to light yellow powder, freely soluble in water and in methanol; sparingly soluble in alcohol; practically insoluble in chloroform and in ether. It dissolves in aqueous solutions of alkali hydroxides and carbonates. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Inactive ingredients in the tablet formulation are: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, sodium chloride, povidone (K-30), hypromellose, talc, hypromellose phthalate, triethyl citrate, polyethylene glycol 6000, corn starch, lactose anhydrous, low substituted hydroxypropyl cellulose, crospovidone, colloidal silicon dioxide and magnesium stearate. This drug product meets USP Dissolution Test 5."
}
]
}
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<NDCList>
<NDC>
<NDCCode>71205-512-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (71205-512-60) </PackageDescription>
<NDC11Code>71205-0512-60</NDC11Code>
<ProductNDC>71205-512</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levothyroxine Sodium</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200803</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021342</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-04-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypothyroidism. Levothyroxine sodium tablets are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary) and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression. Levothyroxine sodium tablets are indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium tablets may induce hyperthyroidism [see Warnings and Precautions (5.4)]. Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.</IndicationAndUsage>
<Description>Levothyroxine sodium tablets, USP contain synthetic crystalline L-3,3',5,5'- tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4NNaO4 xH2O (where x = 5), molecular weight of 798.86 g/mol (anhydrous) and structural formula as shown:. Levothyroxine sodium tablets for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients Magnesium Stearate, NF; Microcrystalline Cellulose, NF; Colloidal Silicone Dioxide, NF; and Sodium Starch Glycolate, NF. Each tablet strength meets USP Dissolution Test 2. Table 6 provides a listing of the color additives by tablet strength:. Table 6. Levothyroxine Sodium Tablets Color Additives.</Description>
</NDC>
<NDC>
<NDCCode>71205-512-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (71205-512-30) </PackageDescription>
<NDC11Code>71205-0512-30</NDC11Code>
<ProductNDC>71205-512</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levothyroxine Sodium</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200803</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021342</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-04-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypothyroidism. Levothyroxine sodium tablets are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary) and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression. Levothyroxine sodium tablets are indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium tablets may induce hyperthyroidism [see Warnings and Precautions (5.4)]. Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.</IndicationAndUsage>
<Description>Levothyroxine sodium tablets, USP contain synthetic crystalline L-3,3',5,5'- tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4NNaO4 xH2O (where x = 5), molecular weight of 798.86 g/mol (anhydrous) and structural formula as shown:. Levothyroxine sodium tablets for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients Magnesium Stearate, NF; Microcrystalline Cellulose, NF; Colloidal Silicone Dioxide, NF; and Sodium Starch Glycolate, NF. Each tablet strength meets USP Dissolution Test 2. Table 6 provides a listing of the color additives by tablet strength:. Table 6. Levothyroxine Sodium Tablets Color Additives.</Description>
</NDC>
<NDC>
<NDCCode>71205-512-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (71205-512-90) </PackageDescription>
<NDC11Code>71205-0512-90</NDC11Code>
<ProductNDC>71205-512</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levothyroxine Sodium</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200803</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021342</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-04-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypothyroidism. Levothyroxine sodium tablets are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary) and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression. Levothyroxine sodium tablets are indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium tablets may induce hyperthyroidism [see Warnings and Precautions (5.4)]. Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.</IndicationAndUsage>
<Description>Levothyroxine sodium tablets, USP contain synthetic crystalline L-3,3',5,5'- tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4NNaO4 xH2O (where x = 5), molecular weight of 798.86 g/mol (anhydrous) and structural formula as shown:. Levothyroxine sodium tablets for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients Magnesium Stearate, NF; Microcrystalline Cellulose, NF; Colloidal Silicone Dioxide, NF; and Sodium Starch Glycolate, NF. Each tablet strength meets USP Dissolution Test 2. Table 6 provides a listing of the color additives by tablet strength:. Table 6. Levothyroxine Sodium Tablets Color Additives.</Description>
</NDC>
<NDC>
<NDCCode>35356-512-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (35356-512-60) </PackageDescription>
<NDC11Code>35356-0512-60</NDC11Code>
<ProductNDC>35356-512</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol</ProprietaryName>
<NonProprietaryName>Carvedilol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070905</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078251</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>CARVEDILOL</SubstanceName>
<StrengthNumber>6.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070905</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carvedilol tablets USP are an alpha/beta-adrenergic blocking agent indicated for the treatment of: 1 Left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2) , 2 Hypertension (1.3) .</IndicationAndUsage>
<Description>Carvedilol, USP is a nonselective β-adrenergic blocking agent with α1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol, USP is a racemic mixture with the following structure. Carvedilol tablets USP are film-coated tablets containing 3.125 mg, 6.25 mg, 12.5 mg or 25 mg of carvedilol. The 3.125 mg, 6.25 mg and 25 mg tablets are white film coated circular shaped tablets. The 12.5 mg tablets are white film coated capsule shaped tablets. Inactive ingredients consist of colloidal silicon dioxide, crospovidone, hypromellose, lactose, magnesium stearate, polyethylene glycol, polysorbate 80, povidone and titanium dioxide. Carvedilol, USP is a white to off-white powder with a molecular weight of 406.5 and a molecular formula of C24H26N2O4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5). The product meets USP Dissolution test 2.</Description>
</NDC>
<NDC>
<NDCCode>42291-512-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (42291-512-60) </PackageDescription>
<NDC11Code>42291-0512-60</NDC11Code>
<ProductNDC>42291-512</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pioglitazone And Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Pioglitazone And Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150306</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091155</ApplicationNumber>
<LabelerName>AvKARE, Inc.</LabelerName>
<SubstanceName>PIOGLITAZONE HYDROCHLORIDE; METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15; 500</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [CS],PPAR gamma [CS],Thiazolidinedione [EPC],Thiazolidinediones [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Biguanide [EPC],Biguanides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-04-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150306</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42508-512-07</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (42508-512-07) * 60 mL in 1 TUBE * 57 g in 1 TUBE</PackageDescription>
<NDC11Code>42508-0512-07</NDC11Code>
<ProductNDC>42508-512</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Abc Arbonne Baby Care Little Bundles Set</ProprietaryName>
<NonProprietaryName>Dimethicone And Zinc Oxide</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20150901</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Arbonne International, LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2018-12-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>42549-512-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (42549-512-60)</PackageDescription>
<NDC11Code>42549-0512-60</NDC11Code>
<ProductNDC>42549-512</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091124</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078428</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Postherpetic Neuralgia. Gabapentin Capsules is indicated for the management of postherpetic neuralgia in adults. Epilepsy. Gabapentin Capsules is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in patients over 12 years of age with epilepsy. Gabapentin Capsules is also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 – 12 years.</IndicationAndUsage>
<Description>Gabapentin Capsules are supplied as imprinted hard shell capsules containing 100 mg, 300 mg, and 400 mg of gabapentin. The inactive ingredients for the capsules are magnesium stearate, pregelatinized starch, starch and talc. The 100 mg capsule shell contains gelatin, sodium lauryl sulfate and titanium dioxide. The 300 mg capsule shell contains gelatin, sodium lauryl sulfate, titanium dioxide, and iron oxide yellow. The 400 mg capsule shell contains gelatin, sodium lauryl sulfate, titanium dioxide, FD&C Yellow No.6 and FD&C Blue No.1. Gabapentin is described as 1-(aminomethyl)cyclohexaneacetic acid with a molecular formula of C9H17NO2 and a molecular weight of 171.24. The structural formula of gabapentin is. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. 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 –1.25.</Description>
</NDC>
<NDC>
<NDCCode>43063-512-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (43063-512-60) </PackageDescription>
<NDC11Code>43063-0512-60</NDC11Code>
<ProductNDC>43063-512</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131018</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091393</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>43333-512-60</NDCCode>
<PackageDescription>.1 mL in 1 POUCH (43333-512-60) </PackageDescription>
<NDC11Code>43333-0512-60</NDC11Code>
<ProductNDC>43333-512</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antibacterial Wipes</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>SWAB</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200902</StartMarketingDate>
<EndMarketingDate>20220902</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Tonic Bath & Body Products Shenzhen Ltd</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200902</StartMarketingDatePackage>
<EndMarketingDatePackage>20220902</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>51862-512-60</NDCCode>
<PackageDescription>1 CAN in 1 CARTON (51862-512-60) / 60 g in 1 CAN</PackageDescription>
<NDC11Code>51862-0512-60</NDC11Code>
<ProductNDC>51862-512</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Calcipotriene</ProprietaryName>
<NonProprietaryName>Calcipotriene</NonProprietaryName>
<DosageFormName>AEROSOL, FOAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210215</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022563</ApplicationNumber>
<LabelerName>Mayne Pharma</LabelerName>
<SubstanceName>CALCIPOTRIENE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/g</StrengthUnit>
<Pharm_Classes>Vitamin D Analog [EPC], Vitamin D [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Calcipotriene foam is indicated for the topical treatment of plaque psoriasis of the scalp and body in adults and pediatric patients 4 years of age and older.</IndicationAndUsage>
<Description>Calcipotriene foam contains the compound calcipotriene, a synthetic vitamin D3 analog, in an aqueous-based emulsion foam vehicle for topical dermatologic use. Chemically, calcipotriene is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19), 22-tetraene- 1α,3β,24-triol. The structural formula is represented below. Molecular Formula: C27H40O3 Molecular Weight: 412.6. Calcipotriene is a white or off-white crystalline substance. Calcipotriene foam contains calcipotriene 50 mcg/g in an aqueous-based emulsion foam vehicle consisting of cetyl alcohol, dibasic sodium phosphate, dl-α-tocopherol, edetate disodium, isopropyl myristate, light mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, stearyl alcohol, and white petrolatum. Calcipotriene foam is dispensed from an aluminum can pressurized with a hydrocarbon (propane/n-butane/isobutane) propellant.</Description>
</NDC>
<NDC>
<NDCCode>52959-512-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (52959-512-60)</PackageDescription>
<NDC11Code>52959-0512-60</NDC11Code>
<ProductNDC>52959-512</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketorolac Tromethamine</ProprietaryName>
<NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100420</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074754</ApplicationNumber>
<LabelerName>H.J. Harkins Company, Inc.</LabelerName>
<SubstanceName>KETOROLAC TROMETHAMINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac tromethamine. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.</IndicationAndUsage>
<Description>Ketorolac tromethamine is a member of the pyrrolo-pyrrole group of non-steroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is (±)-5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol. The structural formula is. C19H24N2O6 M.W. 376.41. Ketorolac tromethamine is a racemic mixture of [-]S and [+]R ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26. Ketorolac tromethamine tablets are round, white, unscored, film-coated tablets. Each tablet, for oral administration, contains 10 mg ketorolac tromethamine, the active ingredient. In addition, each tablet contains the following inactive ingredients: hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>55513-512-60</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (55513-512-60) / 120 TABLET, COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>55513-0512-60</NDC11Code>
<ProductNDC>55513-512</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lumakras</ProprietaryName>
<NonProprietaryName>Sotorasib</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240627</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA214665</ApplicationNumber>
<LabelerName>Amgen Inc</LabelerName>
<SubstanceName>SOTORASIB</SubstanceName>
<StrengthNumber>240</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240627</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LUMAKRAS is an inhibitor of the RAS GTPase family indicated for. KRAS G12C-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC): 1 As a single agent, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. (1.1).</IndicationAndUsage>
<Description>Sotorasib is an inhibitor of the RAS GTPase family. The molecular formula is C30H30F2N6O3, and the molecular weight is 560.6 g/mol. The chemical name of sotorasib is 6-fluoro-7-(2-fluoro-6-hydroxyphenyl)-(1M)-1-[4-methyl-2-(propan-2-yl)pyridin-3-yl]-4-[(2S)-2-methyl-4-(prop-2-enoyl)piperazin-1-yl]pyrido[2,3-d]pyrimidin-2(1H)-one. The chemical structure of sotorasib is shown below. Sotorasib has pKa values of 8.06 and 4.56. The solubility of sotorasib in the aqueous media decreases over the range pH 1.2 to 6.8 from 1.3 mg/mL to 0.03 mg/mL. LUMAKRAS is supplied as film-coated tablets for oral use containing 320 mg, 240 mg or 120 mg of sotorasib. Inactive ingredients in the tablet core are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, and magnesium stearate. The film coating material consists of polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow and iron oxide red (320 mg tablet only).</Description>
</NDC>
<NDC>
<NDCCode>63187-512-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (63187-512-60) </PackageDescription>
<NDC11Code>63187-0512-60</NDC11Code>
<ProductNDC>63187-512</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120807</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040886</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2020-03-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phentermine Hydrochloride, USP 15 mg and 30 mg is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥30 kg/m2, or≥27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. The limited usefulness of agents of this class, including Phentermine hydrochloride, [see CLINICAL PHARMACOLOGY (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
<Description>Phentermine Hydrochloride USP has the chemical name of α, α -Dimethylphenethylamine hydrochloride. The structural formula is as follows. Phentermine Hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols; slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride, an anorectic agent for oral administration, is available as. a) powder-filled capsules containing 15 mg Phentermine hydrochloride (equivalent to 12 mg Phentermine) or 30 mg Phentermine hydrochloride (equivalent to 24 mg Phentermine) and inactive ingredients: corn starch, gelatin, lactose monohydrate and magnesium stearate. In addition, the 15 mg capsules contain D&C Yellow #10, FD&C Blue #1, FD&C Red #3, FD&C Red #40, titanium dioxide and the 30 mg capsules contain D&C Yellow #10, FD&C Red #3, titanium dioxide. b) bead-filled capsules containing 30 mg Phentermine hydrochloride (equivalent to 24 mg Phentermine) and inactive ingredients: corn starch, sucrose, hypromellose, povidone, and talc. In addition, the capsule contains FD&C blue #1/Brilliant blue FCF Aluminum Lake, D&C red #28 and gelatin.</Description>
</NDC>
<NDC>
<NDCCode>68001-512-06</NDCCode>
<PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68001-512-06) </PackageDescription>
<NDC11Code>68001-0512-06</NDC11Code>
<ProductNDC>68001-512</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quetiapine Fumarate</ProprietaryName>
<NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210831</StartMarketingDate>
<EndMarketingDate>20250331</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090681</ApplicationNumber>
<LabelerName>Bluepoint Laboratories</LabelerName>
<SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210831</StartMarketingDatePackage>
<EndMarketingDatePackage>20250331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Quetiapine Extended-release tablet is an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder, manic, or mixed episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2), 4 Major depressive disorder, adjunctive therapy with antidepressants (1.3).</IndicationAndUsage>
<Description>Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [ b,f ] [1,4] thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C 42H 50N 6O 4S 2C 4H 4O 4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is:. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine Extended-release tablets, USP are supplied for oral administration as 150 mg (white), 200 mg (yellow), 300 mg (light yellow), and 400 mg (white). All tablets are round shaped and film coated. Inactive ingredients for quetiapine extended-release tablets, USP are lactose monohydrate, sodium chloride, hydroxypropyl methylcellulose, povidone K30, talc and magnesium stearate. The film coating for all quetiapine extended-release tablets contain hypromellose, polyethylene glycol 400 and titanium dioxide. In addition, iron oxide yellow (200 and 300 mg tablets) is included in the film coating of specific strengths. Each 150 mg tablet contains 173 mg of quetiapine fumarate, USP equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230 mg of quetiapine fumarate, USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345 mg of quetiapine fumarate, USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 461 mg of quetiapine fumarate, USP equivalent to 400 mg quetiapine. Quetiapine Extended-release tablets, USP meet USP Dissolution Test 2.</Description>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antibacterial Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200501</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Hit Promotional Products, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>68</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-05</LastUpdate>
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<SamplePackage>N</SamplePackage>
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<PackageDescription>1 KIT in 1 CARTON (70868-510-30) * 60 CAPSULE in 1 BOTTLE (70868-512-30) * 90 CAPSULE in 1 BOTTLE (70868-513-30) * 30 TABLET in 1 BOTTLE (70868-511-30) </PackageDescription>
<NDC11Code>70868-0510-30</NDC11Code>
<ProductNDC>70868-510</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Accentrate Pnv</ProprietaryName>
<NonProprietaryName>Prenatal Multivitamin Tablet And Combination Omega-3 Softgel/mineral Capsule</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250217</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Key Therapeutics</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Accentrate® PNV (Folate/Omega-3/Iron) (6 mg-210 mg-10 mg) is a Prescription Prenatal Multivitamin Tablet and combination Omega-3 Softgel/Mineral Capsule indicated for preventing neural tube defects and use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers.</IndicationAndUsage>
<Description>Accentrate® PNV (Folate/Omega-3/Iron) (6 mg-210 mg-10 mg) is an orally administered Prescription Prenatal Multivitamin Tablet and combination Omega-3 Softgel/Mineral Capsule. Accentrate® PNV contains a prenatal tablet, omega-3 softgels, and mineral capsules. Each one tablet contains 6 mg of L-methylfolate Calcium, each two softgel serving contains 210 mg of EPA and DHA, and each three capsule serving contain 10 mg of iron. Each prenatal tablet contains:. Each two omega-3 softgel serving contains:. CONTAINS: Shellfish (Krill). Each three mineral capsule serving contains:.</Description>
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<NDC>
<NDCCode>70934-512-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (70934-512-60) </PackageDescription>
<NDC11Code>70934-0512-60</NDC11Code>
<ProductNDC>70934-512</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200122</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074891</ApplicationNumber>
<LabelerName>Denton Pharma, Inc. dba Northwind Pharmaceuticals</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200122</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>71610-512-60</NDCCode>
<PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-512-60) </PackageDescription>
<NDC11Code>71610-0512-60</NDC11Code>
<ProductNDC>71610-512</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Succinate</ProprietaryName>
<NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200831</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA019962</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-06-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol Succinate is a beta1-selective adrenoceptor blocking agent. Metoprolol Succinate is indicated for the treatment of: : 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Angina Pectoris. (1.2), 3 Heart Failure - for the treatment of stable, symptomatic (NYHA Class II or III) heart failure of ischemic, hypertensive, or cardiomyopathic origin. (1.3).</IndicationAndUsage>
<Description>Metoprolol succinate, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablet has been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: silicon dioxide, cellulose compounds, sodium stearyl fumarate, polyethylene glycol, titanium dioxide, paraffin.</Description>
</NDC>
<NDC>
<NDCCode>72789-512-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (72789-512-60) </PackageDescription>
<NDC11Code>72789-0512-60</NDC11Code>
<ProductNDC>72789-512</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19730112</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA083177</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251029</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide tablets are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.</IndicationAndUsage>
<Description>Hydrochlorothiazide, USP is a diuretic and antihypertensive. It is the 3,4-dihydro derivative of chlorothiazide. It is chemically designated as 6-chloro-3,4-dihydro-2 H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide and has the following structural formula:. C 7H 8ClN 3O 4S 2 M.W. 297.74. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder which is slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids. Each tablet for oral administration contains 25 mg or 50 mg hydrochlorothiazide, USP. In addition, each tablet contains the following inactive ingredients: corn starch, dibasic calcium phosphate dihydrate, FD&C Yellow No. 6 Aluminum Lake, lactose monohydrate and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>76420-512-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (76420-512-60) </PackageDescription>
<NDC11Code>76420-0512-60</NDC11Code>
<ProductNDC>76420-512</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quetiapine</ProprietaryName>
<NonProprietaryName>Quetiapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201504</ApplicationNumber>
<LabelerName>ASCLEMED USA INC.</LabelerName>
<SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251021</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Quetiapine is an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia ( 1.1) , 2 Bipolar I disorder manic episodes ( 1.2) , 3 Bipolar disorder, depressive episodes ( 1.2) .</IndicationAndUsage>
<Description>Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [ b,f] [1,4]thiazepin-11-yl-1-piperazinyl) ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C 42H 50N 6O 4S 2C 4H 4O 4and it has a molecular weight of 883.11 (fumarate salt). The structural formula is:. Quetiapine fumarate USP is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablets, USP is supplied for oral administration as 25 mg (round peach), 50 mg (round, white), 100 mg (round yellow), 150 mg (round, off white to light yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are povidone, dibasic dicalcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, hypromellose, polyethylene glycol and titanium dioxide. The 25 mg tablets contain red iron oxide and yellow iron oxide and the 100 mg, 150 mg and 400 mg tablets contain only yellow iron oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate USP equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate USP equivalent to 100 mg quetiapine. Each 150 mg tablet contains 172.70 mg of quetiapine fumarate USP equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.27 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.40 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.54 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine.</Description>
</NDC>
<NDC>
<NDCCode>77610-512-01</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, PUMP (77610-512-01) </PackageDescription>
<NDC11Code>77610-0512-01</NDC11Code>
<ProductNDC>77610-512</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200511</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>IMKOR LIMITED LIABILITY COMPANY</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200511</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0591-4575-60</NDCCode>
<PackageDescription>60 TABLET, DELAYED RELEASE in 1 BOTTLE (0591-4575-60) </PackageDescription>
<NDC11Code>00591-4575-60</NDC11Code>
<ProductNDC>0591-4575</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline Hyclate</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190814</StartMarketingDate>
<EndMarketingDate>20270630</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090134</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190814</StartMarketingDatePackage>
<EndMarketingDatePackage>20270630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxycycline hyclate delayed-release tablets are a tetracycline-class drug indicated for: 1 Rickettsial infections (1.1) , 2 Sexually transmitted infections (1.2) , 3 Respiratory tract infections (1.3) , 4 Specific bacterial infections (1.4) , 5 Ophthalmic infections (1.5) , 6 Anthrax, including inhalational anthrax (post-exposure) (1.6) , 7 Alternative treatment for selected infections when penicillin is contraindicated (1.7) , 8 Adjunctive therapy in acute intestinal amebiasis and severe acne (1.8) , 9 Prophylaxis of malaria (1.9).</IndicationAndUsage>
<Description>Doxycycline hyclate delayed-release tablets USP, for oral administration, contain specially coated pellets of doxycycline hyclate, USP, a tetracycline class drug synthetically derived from oxytetracycline, in a delayed-release formulation for oral administration. The structural formula for doxycycline hyclate, USP is. The molecular formula is C22H24N2O8 HCl ½ C2H6O ½ H2O and a molecular weight of 512.9. The chemical name for doxycycline hyclate, USP is 4-(dimethylamino)-1,4,4α,5,5α,6,11,12α-octahydro-3,5,10,12, 12α-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacencarboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline hyclate, USP is a yellow crystalline powder soluble in water and in solutions of alkali hydroxides and carbonates. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each tablet contains doxycycline 50 mg or 200 mg equivalent to doxycycline hyclate 57.7 mg or 230.8 mg, respectively. Inactive ingredients in the tablet formulation are: crospovidone, D&C Yellow #10 Aluminum Lake, hypromellose 2910, hypromellose phthalate, magnesium stearate, mannitol, microcrystalline cellulose, povidone, silicified microcrystalline cellulose, talc, and triethyl citrate. USP Dissolution test pending.</Description>
</NDC>
<NDC>
<NDCCode>23155-141-06</NDCCode>
<PackageDescription>60 TABLET, DELAYED RELEASE in 1 BOTTLE (23155-141-06) </PackageDescription>
<NDC11Code>23155-0141-06</NDC11Code>
<ProductNDC>23155-141</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline Hyclate</ProprietaryName>
<ProprietaryNameSuffix>Delayed Release</ProprietaryNameSuffix>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130430</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200856</ApplicationNumber>
<LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxycycline hyclate delayed-release tablets are a tetracycline-class drug indicated for: Rickettsial infections (1.1) Sexually transmitted infections (1.2) Respiratory tract infections (1.3) Specific bacterial infections (1.4) Ophthalmic infections (1.5) Anthrax, including inhalational anthrax (post-exposure) (1.6) Alternative treatment for selected infections when penicillin is contraindicated (1.7) Adjunctive therapy in acute intestinal amebiasis and severe acne (1.8) Prophylaxis of malaria (1.9). UsageTo reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate delayed-release tablets, should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.10).</IndicationAndUsage>
<Description>Doxycycline hyclate delayed-release tablets, USP, contain specially coated pellets of doxycycline hyclate, a tetracycline class drug synthetically derived from oxytetracycline, in a delayed-release formulation for oral administration. The structural formula for doxycycline hyclate is. with a molecular formula of C22H24N2O8, HCl, ½ C2H6O, ½ H2O and a molecular weight of 512.9. The chemical name for doxycycline hyclate is [4S(4aR,5S,5aR,6R,12aS)]-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-deoxonaphthacene-2-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline hyclate is a yellow crystalline powder soluble in water and in solutions of alkali hydroxides and carbonates. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each tablet contains doxycycline 75 mg, 100 mg, 150 mg or 200 mg (equivalent to doxycycline hyclate 86.6 mg, 115.4 mg, 173.1 mg or 230.8 mg). Inactive ingredients in the tablet formulation are: lactose monohydrate, microcrystalline cellulose; sodium lauryl sulfate, sodium chloride, hypromellose phthalate, hypromellose, triethyl citrate, anhydrous lactose, crospovidone, stearic acid, magnesium stearate. The tablets also contain opadry 03K29121 clear, which contains: hypromellose and triacetin. Each doxycycline hyclate delayed-release tablets 75 mg tablet contains 4.8 mg (0.208 mEq) of sodium, each doxycycline hyclate delayed-release tablets 100 mg tablet contains 6.4 mg (0.278 mEq) of sodium, each doxycycline hyclate delayed-release tablets 150 mg tablet contains 9.6 mg (0.417 mEq) of sodium, and each doxycycline hyclate delayed-release tablets 200 mg tablet contains 12.8 mg (0.556 mEq) of sodium. USP dissolution test pending.</Description>
</NDC>
<NDC>
<NDCCode>23155-143-06</NDCCode>
<PackageDescription>60 TABLET, DELAYED RELEASE in 1 BOTTLE (23155-143-06) </PackageDescription>
<NDC11Code>23155-0143-06</NDC11Code>
<ProductNDC>23155-143</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline Hyclate</ProprietaryName>
<ProprietaryNameSuffix>Delayed Release</ProprietaryNameSuffix>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130430</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200856</ApplicationNumber>
<LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxycycline hyclate delayed-release tablets are a tetracycline-class drug indicated for: Rickettsial infections (1.1) Sexually transmitted infections (1.2) Respiratory tract infections (1.3) Specific bacterial infections (1.4) Ophthalmic infections (1.5) Anthrax, including inhalational anthrax (post-exposure) (1.6) Alternative treatment for selected infections when penicillin is contraindicated (1.7) Adjunctive therapy in acute intestinal amebiasis and severe acne (1.8) Prophylaxis of malaria (1.9). UsageTo reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate delayed-release tablets, should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.10).</IndicationAndUsage>
<Description>Doxycycline hyclate delayed-release tablets, USP, contain specially coated pellets of doxycycline hyclate, a tetracycline class drug synthetically derived from oxytetracycline, in a delayed-release formulation for oral administration. The structural formula for doxycycline hyclate is. with a molecular formula of C22H24N2O8, HCl, ½ C2H6O, ½ H2O and a molecular weight of 512.9. The chemical name for doxycycline hyclate is [4S(4aR,5S,5aR,6R,12aS)]-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-deoxonaphthacene-2-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline hyclate is a yellow crystalline powder soluble in water and in solutions of alkali hydroxides and carbonates. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each tablet contains doxycycline 75 mg, 100 mg, 150 mg or 200 mg (equivalent to doxycycline hyclate 86.6 mg, 115.4 mg, 173.1 mg or 230.8 mg). Inactive ingredients in the tablet formulation are: lactose monohydrate, microcrystalline cellulose; sodium lauryl sulfate, sodium chloride, hypromellose phthalate, hypromellose, triethyl citrate, anhydrous lactose, crospovidone, stearic acid, magnesium stearate. The tablets also contain opadry 03K29121 clear, which contains: hypromellose and triacetin. Each doxycycline hyclate delayed-release tablets 75 mg tablet contains 4.8 mg (0.208 mEq) of sodium, each doxycycline hyclate delayed-release tablets 100 mg tablet contains 6.4 mg (0.278 mEq) of sodium, each doxycycline hyclate delayed-release tablets 150 mg tablet contains 9.6 mg (0.417 mEq) of sodium, and each doxycycline hyclate delayed-release tablets 200 mg tablet contains 12.8 mg (0.556 mEq) of sodium. USP dissolution test pending.</Description>
</NDC>
<NDC>
<NDCCode>23155-611-06</NDCCode>
<PackageDescription>60 TABLET, DELAYED RELEASE in 1 BOTTLE (23155-611-06) </PackageDescription>
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<ProductNDC>23155-611</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline Hyclate</ProprietaryName>
<ProprietaryNameSuffix>Delayed Release</ProprietaryNameSuffix>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20180316</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200856</ApplicationNumber>
<LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180316</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxycycline hyclate delayed-release tablets are a tetracycline-class drug indicated for: Rickettsial infections (1.1) Sexually transmitted infections (1.2) Respiratory tract infections (1.3) Specific bacterial infections (1.4) Ophthalmic infections (1.5) Anthrax, including inhalational anthrax (post-exposure) (1.6) Alternative treatment for selected infections when penicillin is contraindicated (1.7) Adjunctive therapy in acute intestinal amebiasis and severe acne (1.8) Prophylaxis of malaria (1.9). UsageTo reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate delayed-release tablets, should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.10).</IndicationAndUsage>
<Description>Doxycycline hyclate delayed-release tablets, USP, contain specially coated pellets of doxycycline hyclate, a tetracycline class drug synthetically derived from oxytetracycline, in a delayed-release formulation for oral administration. The structural formula for doxycycline hyclate is. with a molecular formula of C22H24N2O8, HCl, ½ C2H6O, ½ H2O and a molecular weight of 512.9. The chemical name for doxycycline hyclate is [4S(4aR,5S,5aR,6R,12aS)]-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-deoxonaphthacene-2-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline hyclate is a yellow crystalline powder soluble in water and in solutions of alkali hydroxides and carbonates. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each tablet contains doxycycline 75 mg, 100 mg, 150 mg or 200 mg (equivalent to doxycycline hyclate 86.6 mg, 115.4 mg, 173.1 mg or 230.8 mg). Inactive ingredients in the tablet formulation are: lactose monohydrate, microcrystalline cellulose; sodium lauryl sulfate, sodium chloride, hypromellose phthalate, hypromellose, triethyl citrate, anhydrous lactose, crospovidone, stearic acid, magnesium stearate. The tablets also contain opadry 03K29121 clear, which contains: hypromellose and triacetin. Each doxycycline hyclate delayed-release tablets 75 mg tablet contains 4.8 mg (0.208 mEq) of sodium, each doxycycline hyclate delayed-release tablets 100 mg tablet contains 6.4 mg (0.278 mEq) of sodium, each doxycycline hyclate delayed-release tablets 150 mg tablet contains 9.6 mg (0.417 mEq) of sodium, and each doxycycline hyclate delayed-release tablets 200 mg tablet contains 12.8 mg (0.556 mEq) of sodium. USP dissolution test pending.</Description>
</NDC>
<NDC>
<NDCCode>33358-512-30</NDCCode>
<PackageDescription>30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (33358-512-30)</PackageDescription>
<NDC11Code>33358-0512-30</NDC11Code>
<ProductNDC>33358-512</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ondansetron</ProprietaryName>
<NonProprietaryName>Ondansetron</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090469</ApplicationNumber>
<LabelerName>RxChange Co.</LabelerName>
<SubstanceName>ONDANSETRON</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<Description>The active ingredient in ondansetron orally disintegrating tablets, USP is ondansetron base, the racemic form of ondansetron, and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one. It has the following structural formula. The molecular formula is C18H19N3O representing a molecular weight of 293.4. Ondansetron is a white to off-white powder.Each 4 mg ondansetron orally disintegrating tablet, USP for oral administration contains 4 mg ondansetron base. Each 8 mg ondansetron orally disintegrating tablet, USP for oral administration contains 8 mg ondansetron base. Each ondansetron orally disintegrating tablet also contains the inactive ingredients mannitol, crospovidone, lactose monohydrate, microcrystalline cellulose, aspartame, strawberry guarana flavor, colloidal silicon dioxide, and magnesium stearate. The strawberry guarana flavor contains maltodextrin, propylene glycol, artificial flavors, and acetic acid. Ondansetron orally disintegrating tablets, USP are orally administered formulation of ondansetron which rapidly disintegrates on the tongue and does not require water to aid dissolution or swallowing.This product does not meet USP Disintegration Time. The 4 mg and 8 mg tablets disintegrate in approximately 60 seconds.</Description>
</NDC>
<NDC>
<NDCCode>43547-324-06</NDCCode>
<PackageDescription>60 TABLET, DELAYED RELEASE in 1 BOTTLE (43547-324-06) </PackageDescription>
<NDC11Code>43547-0324-06</NDC11Code>
<ProductNDC>43547-324</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline Hyclate</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161128</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207494</ApplicationNumber>
<LabelerName>Solco Healthcare US LLC</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxycycline hyclate delayed-release tablets are a tetracycline-class drug indicated for: 1 Rickettsial infections (1.1), 2 Sexually transmitted infections (1.2), 3 Respiratory tract infections (1.3), 4 Specific bacterial infections (1.4), 5 Ophthalmic infections (1.5), 6 Anthrax, including inhalational anthrax (post-exposure) (1.6), 7 Alternative treatment for selected infections when penicillin is contraindicated (1.7), 8 Adjunctive therapy in acute intestinal amebiasis and severe acne (1.8), 9 Prophylaxis of malaria (1.9).</IndicationAndUsage>
<Description>Doxycycline hyclate delayed-release tablets, contain specially coated pellets of doxycycline hyclate, USP, a tetracycline class drug synthetically derived from oxytetracycline, in a delayed-release formulation for oral administration. The structural formula for doxycycline hyclate is. with a molecular formula of C22H24N2O8, HCl, ½ C2H6O, ½ H2O and a molecular weight of 512.9. The chemical name for doxycycline hyclate is [4S(4aR,5S,5aR,6R,12aS)]-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-deoxonapthtacene-2-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline hyclate is a yellow crystalline powder soluble in water and in solutions of alkali hydroxides and carbonates. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Inactive ingredients in the tablet formulation are: crospovidone; hypromellose; hypromellose phthalate; lactose monohydrate; magnesium stearate; mannitol; microcrystalline cellulose; povidone; sodium chloride; sodium lauryl sulfate; talc; triethyl citrate. Meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>43547-325-06</NDCCode>
<PackageDescription>60 TABLET, DELAYED RELEASE in 1 BOTTLE (43547-325-06) </PackageDescription>
<NDC11Code>43547-0325-06</NDC11Code>
<ProductNDC>43547-325</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline Hyclate</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161128</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207494</ApplicationNumber>
<LabelerName>Solco Healthcare US LLC</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxycycline hyclate delayed-release tablets are a tetracycline-class drug indicated for: 1 Rickettsial infections (1.1), 2 Sexually transmitted infections (1.2), 3 Respiratory tract infections (1.3), 4 Specific bacterial infections (1.4), 5 Ophthalmic infections (1.5), 6 Anthrax, including inhalational anthrax (post-exposure) (1.6), 7 Alternative treatment for selected infections when penicillin is contraindicated (1.7), 8 Adjunctive therapy in acute intestinal amebiasis and severe acne (1.8), 9 Prophylaxis of malaria (1.9).</IndicationAndUsage>
<Description>Doxycycline hyclate delayed-release tablets, contain specially coated pellets of doxycycline hyclate, USP, a tetracycline class drug synthetically derived from oxytetracycline, in a delayed-release formulation for oral administration. The structural formula for doxycycline hyclate is. with a molecular formula of C22H24N2O8, HCl, ½ C2H6O, ½ H2O and a molecular weight of 512.9. The chemical name for doxycycline hyclate is [4S(4aR,5S,5aR,6R,12aS)]-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-deoxonapthtacene-2-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline hyclate is a yellow crystalline powder soluble in water and in solutions of alkali hydroxides and carbonates. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Inactive ingredients in the tablet formulation are: crospovidone; hypromellose; hypromellose phthalate; lactose monohydrate; magnesium stearate; mannitol; microcrystalline cellulose; povidone; sodium chloride; sodium lauryl sulfate; talc; triethyl citrate. Meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>46708-481-60</NDCCode>
<PackageDescription>60 TABLET, DELAYED RELEASE in 1 BOTTLE (46708-481-60) </PackageDescription>
<NDC11Code>46708-0481-60</NDC11Code>
<ProductNDC>46708-481</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline Hyclate</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220104</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213075</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-04-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate delayed-release tablets and other antibacterial drugs, doxycycline hyclate delayed-release tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Doxycycline is a tetracycline-class antibacterial indicated in the following conditions or disease.</IndicationAndUsage>
<Description>Doxycycline hyclate delayed-release tablets, USP for oral administration, contain specially coated pellets of doxycycline hyclate, USP, a broad-spectrum antibacterial synthetically derived from oxytetracycline, in a delayed-release formulation for oral administration.The structural formula for doxycycline hyclate, USP is. with a molecular formula of C22H24N2O8, HCl, ½ C2H6O, ½ H2O and a molecular weight of 512.9. The chemical designation for doxycycline hyclate is [4S(4aR,5S,5aR,6R,12aS)]-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-deoxonaphthacene-2-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline hyclate, USP is a yellow to light yellow powder, freely soluble in water and in methanol; sparingly soluble in alcohol; practically insoluble in chloroform and in ether. It dissolves in aqueous solutions of alkali hydroxides and carbonates. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Inactive ingredients in the tablet formulation are: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, sodium chloride, povidone (K-30), hypromellose, talc, hypromellose phthalate, triethyl citrate, polyethylene glycol 6000, corn starch, lactose anhydrous, low substituted hydroxypropyl cellulose, crospovidone, colloidal silicon dioxide and magnesium stearate. This drug product meets USP Dissolution Test 5.</Description>
</NDC>
<NDC>
<NDCCode>46708-482-60</NDCCode>
<PackageDescription>60 TABLET, DELAYED RELEASE in 1 BOTTLE (46708-482-60) </PackageDescription>
<NDC11Code>46708-0482-60</NDC11Code>
<ProductNDC>46708-482</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline Hyclate</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220104</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213075</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-04-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate delayed-release tablets and other antibacterial drugs, doxycycline hyclate delayed-release tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Doxycycline is a tetracycline-class antibacterial indicated in the following conditions or disease.</IndicationAndUsage>
<Description>Doxycycline hyclate delayed-release tablets, USP for oral administration, contain specially coated pellets of doxycycline hyclate, USP, a broad-spectrum antibacterial synthetically derived from oxytetracycline, in a delayed-release formulation for oral administration.The structural formula for doxycycline hyclate, USP is. with a molecular formula of C22H24N2O8, HCl, ½ C2H6O, ½ H2O and a molecular weight of 512.9. The chemical designation for doxycycline hyclate is [4S(4aR,5S,5aR,6R,12aS)]-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-deoxonaphthacene-2-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline hyclate, USP is a yellow to light yellow powder, freely soluble in water and in methanol; sparingly soluble in alcohol; practically insoluble in chloroform and in ether. It dissolves in aqueous solutions of alkali hydroxides and carbonates. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Inactive ingredients in the tablet formulation are: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, sodium chloride, povidone (K-30), hypromellose, talc, hypromellose phthalate, triethyl citrate, polyethylene glycol 6000, corn starch, lactose anhydrous, low substituted hydroxypropyl cellulose, crospovidone, colloidal silicon dioxide and magnesium stearate. This drug product meets USP Dissolution Test 5.</Description>
</NDC>
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