{
"NDC": [
{
"NDCCode": "59651-183-25",
"PackageDescription": "5 POUCH in 1 CARTON (59651-183-25) / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL",
"NDC11Code": "59651-0183-25",
"ProductNDC": "59651-183",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Albuterol Sulfate",
"NonProprietaryName": "Albuterol Sulfate",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20200420",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211888",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "ALBUTEROL SULFATE",
"StrengthNumber": ".63",
"StrengthUnit": "mg/3mL",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200420",
"SamplePackage": "N",
"IndicationAndUsage": "Albuterol sulfate inhalation solution is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma (reversible obstructive airway disease).",
"Description": "Albuterol sulfate inhalation solution is a sterile, clear, colorless solution of the sulfate salt of racemic albuterol, albuterol sulfate. Albuterol sulfate is a relatively selective beta 2-adrenergic bronchodilator (see CLINICAL PHARMACOLOGY). The chemical name for albuterol sulfate is α 1 [(tert-butylamino) methyl]-4-hydroxy-m-xylene-α,α’-diol sulfate (2:1) (salt), and its established chemical structure is as follows: The molecular weight of albuterol sulfate is 576.7 and the molecular formula is (C 13H 21NO 3) 2 H 2SO 4. Albuterol sulfate USP is a white or practically white powder, freely soluble in water, slightly soluble in alcohol, in ether and practically insoluble in chloroform. The World Health Organization recommended name for albuterol is salbutamol. Albuterol sulfate inhalation solution is supplied in two strengths in unit dose vials. Each unit dose vial contains either 0.63 mg of albuterol equivalent to 0.75 mg of albuterol sulfate or 1.25 mg of albuterol equivalent to 1.5 mg of albuterol sulfate with sodium chloride and sulfuric acid in a 3-mL isotonic, sterile, aqueous solution. Sodium chloride is added to adjust isotonicity of the solution and sulfuric acid is added to adjust pH of the solution to 3.5 (see HOW SUPPLIED). Albuterol sulfate inhalation solution does not require dilution prior to administration by nebulization. For albuterol sulfate inhalation solution, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari LC Plus TM nebulizer (with face mask or mouthpiece) connected to a Pari PRONEB TM compressor, under in vitro conditions, the mean delivered dose from the mouth piece (% nominal dose) was approximately 43% of albuterol (1.25 mg strength) and 39% of albuterol (0.63 mg strength) at a mean flow rate of 3.6 L/min. The mean nebulization time was 15 minutes or less. Albuterol sulfate inhalation solution should be administered from a jet nebulizer at an adequate flow rate, via a mouthpiece or face mask (see DOSAGE AND ADMINISTRATION)."
},
{
"NDCCode": "59651-183-30",
"PackageDescription": "6 POUCH in 1 CARTON (59651-183-30) / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL",
"NDC11Code": "59651-0183-30",
"ProductNDC": "59651-183",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Albuterol Sulfate",
"NonProprietaryName": "Albuterol Sulfate",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20200420",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211888",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "ALBUTEROL SULFATE",
"StrengthNumber": ".63",
"StrengthUnit": "mg/3mL",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240729",
"SamplePackage": "N",
"IndicationAndUsage": "Albuterol sulfate inhalation solution is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma (reversible obstructive airway disease).",
"Description": "Albuterol sulfate inhalation solution is a sterile, clear, colorless solution of the sulfate salt of racemic albuterol, albuterol sulfate. Albuterol sulfate is a relatively selective beta 2-adrenergic bronchodilator (see CLINICAL PHARMACOLOGY). The chemical name for albuterol sulfate is α 1 [(tert-butylamino) methyl]-4-hydroxy-m-xylene-α,α’-diol sulfate (2:1) (salt), and its established chemical structure is as follows: The molecular weight of albuterol sulfate is 576.7 and the molecular formula is (C 13H 21NO 3) 2 H 2SO 4. Albuterol sulfate USP is a white or practically white powder, freely soluble in water, slightly soluble in alcohol, in ether and practically insoluble in chloroform. The World Health Organization recommended name for albuterol is salbutamol. Albuterol sulfate inhalation solution is supplied in two strengths in unit dose vials. Each unit dose vial contains either 0.63 mg of albuterol equivalent to 0.75 mg of albuterol sulfate or 1.25 mg of albuterol equivalent to 1.5 mg of albuterol sulfate with sodium chloride and sulfuric acid in a 3-mL isotonic, sterile, aqueous solution. Sodium chloride is added to adjust isotonicity of the solution and sulfuric acid is added to adjust pH of the solution to 3.5 (see HOW SUPPLIED). Albuterol sulfate inhalation solution does not require dilution prior to administration by nebulization. For albuterol sulfate inhalation solution, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari LC Plus TM nebulizer (with face mask or mouthpiece) connected to a Pari PRONEB TM compressor, under in vitro conditions, the mean delivered dose from the mouth piece (% nominal dose) was approximately 43% of albuterol (1.25 mg strength) and 39% of albuterol (0.63 mg strength) at a mean flow rate of 3.6 L/min. The mean nebulization time was 15 minutes or less. Albuterol sulfate inhalation solution should be administered from a jet nebulizer at an adequate flow rate, via a mouthpiece or face mask (see DOSAGE AND ADMINISTRATION)."
},
{
"NDCCode": "11489-183-01",
"PackageDescription": "1 TUBE in 1 CARTON (11489-183-01) > 25 g in 1 TUBE",
"NDC11Code": "11489-0183-01",
"ProductNDC": "11489-183",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "No7 Protect And Perfect Intense Advanced Day Cream Spf 30",
"NonProprietaryName": "Avobenzone, Octisalate, Octocrylene",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210914",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "BCM Ltd",
"SubstanceName": "AVOBENZONE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": ".75; 1.25; 1.875",
"StrengthUnit": "g/25g; g/25g; g/25g",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210914",
"SamplePackage": "N",
"IndicationAndUsage": "Directions. apply liberally 15 minutes before sun exposure. reapply at least every 2 hours. use a water resistant sunscreen if swimming or sweating. children under 6 months of age: Ask a doctor. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including. limit time in the sun, especially from 10 a.m - 2 p.m. wear long-sleeved shirts,pants,hats and sunglasses.",
"Description": "No7 already perfect PROTECT & PERFECT COLLECTION. 25 ml e 0.84 Fl. Oz. The complete regime for fresher, younger looking skin. This collection visibly reduces the appearance of deep lines and wrinkles."
},
{
"NDCCode": "12634-183-79",
"PackageDescription": "25 CAPSULE in 1 BOTTLE (12634-183-79)",
"NDC11Code": "12634-0183-79",
"ProductNDC": "12634-183",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20051109",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065271",
"LabelerName": "Apotheca Inc.",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"IndicationAndUsage": "Amoxicillin capsules are a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. : 1 Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. (1.1 – 1.4), 2 In combination for treatment of H. pylori infection and duodenal ulcer disease. (1.5).",
"Description": "Formulation of amoxicillin capsules, USP contains amoxicillin, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as: The amoxicillin molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.45. Each capsule of amoxicillin with blue cap and pink body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The body of the 250 mg capsule is imprinted with ‘A44’ in black ink. The body of the 500 mg capsule is imprinted with ‘A45’ in black ink. Inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, and titanium dioxide. Meets USP Dissolution Test 2."
},
{
"NDCCode": "25021-183-67",
"PackageDescription": "25 VIAL in 1 CARTON (25021-183-67) > 16 mL in 1 VIAL",
"NDC11Code": "25021-0183-67",
"ProductNDC": "25021-183",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefuroxime Sodium",
"NonProprietaryName": "Cefuroxime Sodium",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20160901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064125",
"LabelerName": "Sagent Pharmaceuticals",
"SubstanceName": "CEFUROXIME SODIUM",
"StrengthNumber": "1.5",
"StrengthUnit": "g/16mL",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-12-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20160901",
"SamplePackage": "N",
"IndicationAndUsage": "Cefuroxime for Injection, USP is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases: : 1 Lower Respiratory Tract Infections, including pneumonia, caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Klebsiella spp., Staphylococcus aureus (penicillinase- and non-penicillinase- producing strains), Streptococcus pyogenes, and Escherichia coli. , 2 Urinary Tract Infections caused by Escherichia coli and Klebsiella spp., 3 Skin and Skin Structure Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, Escherichia coli, Klebsiella spp., and Enterobacter spp. , 4 Septicemia caused by Staphylococcus aureus (penicillinase- and non-penicillinase- producing strains), Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae (including ampicillin-resistant strains), and Klebsiella spp., 5 Meningitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Neisseria meningitidis, and Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains). , 6 Gonorrhea: Uncomplicated and disseminated gonococcal infections due to Neisseria gonorrhoeae (penicillinase- and non-penicillinase-producing strains) in both males and females. , 7 Bone and Joint Infections caused by Staphylococcus aureus (penicillinase- and non- penicillinase-producing strains). .",
"Description": "Cefuroxime is a semisynthetic, broad-spectrum, cephalosporin antibiotic for parenteral administration. It is the sodium salt of (6R,7R)-3-carbamoyloxymethyl-7-[Z-2-methoxyimino-2-(fur-2-yl) acetamido] ceph-3-em-4-carboxylate, and it has the following chemical structure:. The empirical formula is C16H15N4NaO8S, representing a molecular weight of 446.4. Cefuroxime for Injection, USP contains approximately 54.2 mg (2.4 mEq) of sodium per gram of cefuroxime activity. Cefuroxime for Injection, USP in sterile crystalline form is supplied in vials equivalent to 750 mg or 1.5 g of cefuroxime as cefuroxime sodium. Solutions of Cefuroxime for Injection, USP range in color from light yellow to amber, depending on the concentration and diluent used. The pH of freshly constituted solutions usually ranges from 6 to 8.5."
},
{
"NDCCode": "64220-183-08",
"PackageDescription": "25 kg in 1 DRUM (64220-183-08) ",
"NDC11Code": "64220-0183-08",
"ProductNDC": "64220-183",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Amlodipine Besylate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20210501",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.",
"SubstanceName": "AMLODIPINE BESYLATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2021-06-10",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "01-MAY-21"
},
{
"NDCCode": "76150-183-32",
"PackageDescription": "4.25 g in 1 TUBE (76150-183-32)",
"NDC11Code": "76150-0183-32",
"ProductNDC": "76150-183",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mineral Lip Bonfire",
"ProprietaryNameSuffix": "Spf 30 Broad Spectrum",
"NonProprietaryName": "Sunscreen",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160401",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Bell International Laboratories, Inc.",
"SubstanceName": "ZINC OXIDE; TITANIUM DIOXIDE",
"StrengthNumber": "1.4; 2.8",
"StrengthUnit": "g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "84603-183-01",
"PackageDescription": "4.25 g in 1 TUBE (84603-183-01) ",
"NDC11Code": "84603-0183-01",
"ProductNDC": "84603-183",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Basin Lime Sugar Spf 15 Broad Spectrum Sunscreen Lip Balm",
"NonProprietaryName": "Avobenzone, Octinoxate, Octisalate, Octocrylene",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220210",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Retail Concepts of Minnesota, Inc.",
"SubstanceName": "OCTINOXATE; AVOBENZONE; OCTOCRYLENE; OCTISALATE",
"StrengthNumber": "7.5; 3; 5; 5",
"StrengthUnit": "g/100g; g/100g; g/100g; g/100g",
"Status": "Active",
"LastUpdate": "2025-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220210",
"SamplePackage": "N",
"IndicationAndUsage": "Usehelps prevent sunburn."
},
{
"NDCCode": "59651-184-25",
"PackageDescription": "5 POUCH in 1 CARTON (59651-184-25) / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL",
"NDC11Code": "59651-0184-25",
"ProductNDC": "59651-184",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Albuterol Sulfate",
"NonProprietaryName": "Albuterol Sulfate",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20200420",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211888",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "ALBUTEROL SULFATE",
"StrengthNumber": "1.25",
"StrengthUnit": "mg/3mL",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200420",
"SamplePackage": "N",
"IndicationAndUsage": "Albuterol sulfate inhalation solution is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma (reversible obstructive airway disease).",
"Description": "Albuterol sulfate inhalation solution is a sterile, clear, colorless solution of the sulfate salt of racemic albuterol, albuterol sulfate. Albuterol sulfate is a relatively selective beta 2-adrenergic bronchodilator (see CLINICAL PHARMACOLOGY). The chemical name for albuterol sulfate is α 1 [(tert-butylamino) methyl]-4-hydroxy-m-xylene-α,α’-diol sulfate (2:1) (salt), and its established chemical structure is as follows: The molecular weight of albuterol sulfate is 576.7 and the molecular formula is (C 13H 21NO 3) 2 H 2SO 4. Albuterol sulfate USP is a white or practically white powder, freely soluble in water, slightly soluble in alcohol, in ether and practically insoluble in chloroform. The World Health Organization recommended name for albuterol is salbutamol. Albuterol sulfate inhalation solution is supplied in two strengths in unit dose vials. Each unit dose vial contains either 0.63 mg of albuterol equivalent to 0.75 mg of albuterol sulfate or 1.25 mg of albuterol equivalent to 1.5 mg of albuterol sulfate with sodium chloride and sulfuric acid in a 3-mL isotonic, sterile, aqueous solution. Sodium chloride is added to adjust isotonicity of the solution and sulfuric acid is added to adjust pH of the solution to 3.5 (see HOW SUPPLIED). Albuterol sulfate inhalation solution does not require dilution prior to administration by nebulization. For albuterol sulfate inhalation solution, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari LC Plus TM nebulizer (with face mask or mouthpiece) connected to a Pari PRONEB TM compressor, under in vitro conditions, the mean delivered dose from the mouth piece (% nominal dose) was approximately 43% of albuterol (1.25 mg strength) and 39% of albuterol (0.63 mg strength) at a mean flow rate of 3.6 L/min. The mean nebulization time was 15 minutes or less. Albuterol sulfate inhalation solution should be administered from a jet nebulizer at an adequate flow rate, via a mouthpiece or face mask (see DOSAGE AND ADMINISTRATION)."
},
{
"NDCCode": "59651-273-25",
"PackageDescription": "250 CAPSULE in 1 BOTTLE (59651-273-25) ",
"NDC11Code": "59651-0273-25",
"ProductNDC": "59651-273",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prazosin Hydrochloride",
"NonProprietaryName": "Prazosin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213052",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "PRAZOSIN HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2023-04-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230331",
"SamplePackage": "N",
"IndicationAndUsage": "Prazosin hydrochloride capsules are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Prazosin hydrochloride capsules can be used alone or in combination with other antihypertensive drugs such as diuretics or beta-adrenergic blocking agents.",
"Description": "Prazosin hydrochloride, a quinazoline derivative, is the first of a new chemical class of antihypertensives. It is the hydrochloride salt of 1-(4-amino-6, 7-dimethoxy-2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is. Molecular formula C19H21N5O4.HCl. It is a white or almost white crystalline powder, very slightly soluble in water, slightly soluble in alcohol and methanol, practically insoluble in acetone and has a molecular weight of 419.87. Each 1 mg capsule of prazosin hydrochloride USP, for oral use contains drug equivalent to 1 mg free base. Prazosin hydrochloride capsules USP contains the following inactive ingredients: corn starch, magnesium stearate, sodium lauryl sulfate, sucrose. The hard gelatin capsules contain gelatin and titanium dioxide. In addition, the 1 mg hard gelatin capsules contain D&C Yellow 10 and FD&C Yellow 6; the 2 mg hard gelatin capsules contain D&C Yellow 10, FD&C Blue 1, FD&C Red 3 and FD&C Yellow 6; the 5 mg hard gelatin capsules contains D&C Yellow 10, FD&C Blue 1, FD&C Red 3 and FD&C Yellow 6. The capsule shells are imprinted with black ink which contains black iron oxide, potassium hydroxide and shellac. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "59651-339-25",
"PackageDescription": "2500 TABLET, FILM COATED in 1 BAG (59651-339-25) ",
"NDC11Code": "59651-0339-25",
"ProductNDC": "59651-339",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Minocycline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20200501",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2021-11-18",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "01-MAY-20"
},
{
"NDCCode": "59651-548-25",
"PackageDescription": "25000 TABLET, EXTENDED RELEASE in 1 BAG (59651-548-25) ",
"NDC11Code": "59651-0548-25",
"ProductNDC": "59651-548",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"StartMarketingDate": "20240415",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2024-05-07",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "15-APR-24"
},
{
"NDCCode": "59651-562-25",
"PackageDescription": "25000 CAPSULE, DELAYED RELEASE in 1 BAG (59651-562-25) ",
"NDC11Code": "59651-0562-25",
"ProductNDC": "59651-562",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Esomeprazole Magnesium",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"StartMarketingDate": "20231120",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "ESOMEPRAZOLE MAGNESIUM TRIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2024-12-28",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20-NOV-23"
},
{
"NDCCode": "59651-658-04",
"PackageDescription": "4 BOTTLE in 1 CARTON (59651-658-04) / 25 TABLET in 1 BOTTLE",
"NDC11Code": "59651-0658-04",
"ProductNDC": "59651-658",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitroglycerin",
"NonProprietaryName": "Nitroglycerin",
"DosageFormName": "TABLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20231026",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217879",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "NITROGLYCERIN",
"StrengthNumber": ".4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2023-11-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231026",
"SamplePackage": "N",
"IndicationAndUsage": "Nitroglycerin sublingual tablets are indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.",
"Description": "Nitroglycerin is a stabilized sublingual compressed nitroglycerin tablet that contains 0.3 mg, 0.4 mg, or 0.6 mg nitroglycerin; as well as calcium stearate, colloidal silicon dioxide, glyceryl monostearate, hydrophobic colloidal silica, lactose monohydrate, magnesium stearate and pregelatinized starch (maize). Nitroglycerin, an organic nitrate, is a vasodilating agent. The chemical name for nitroglycerin is 1, 2, 3 propanetriol trinitrate and the chemical structure is:. Molecular weight: 227.09."
},
{
"NDCCode": "59651-876-25",
"PackageDescription": "25000 g in 1 BAG (59651-876-25) ",
"NDC11Code": "59651-0876-25",
"ProductNDC": "59651-876",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Polyethylene Glycol 3350",
"DosageFormName": "POWDER, FOR SOLUTION",
"StartMarketingDate": "20240423",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "POLYETHYLENE GLYCOL 3350",
"StrengthNumber": "17",
"StrengthUnit": "g/17g",
"Status": "Unfinished",
"LastUpdate": "2025-03-26",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "23-APR-24"
},
{
"NDCCode": "59651-988-25",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (59651-988-25) / 25 mL in 1 BOTTLE, GLASS",
"NDC11Code": "59651-0988-25",
"ProductNDC": "59651-988",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glycerol Phenylbutyrate",
"NonProprietaryName": "Glycerol Phenylbutyrate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20260415",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA220313",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "GLYCEROL PHENYLBUTYRATE",
"StrengthNumber": "1.1",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260415",
"SamplePackage": "N",
"IndicationAndUsage": "Glycerol phenylbutyrate oral liquid is indicated for use as a nitrogen-binding agent for chronic management of patients with urea cycle disorders (UCDs) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. Glycerol phenylbutyrate oral liquid must be used with dietary protein restriction and, in some cases, dietary supplements (e.g., essential amino acids, arginine, citrulline, protein-free calorie supplements). Limitations of Use: 1 Glycerol phenylbutyrate oral liquid is not indicated for the treatment of acute hyperammonemia in patients with UCDs because more rapidly acting interventions are essential to reduce plasma ammonia levels., 2 The safety and efficacy of glycerol phenylbutyrate oral liquid for the treatment of N-acetylglutamate synthase (NAGS) deficiency has not been established.",
"Description": "Glycerol phenylbutyrate is a clear, colorless to pale yellow oral liquid. It is freely soluble in toluene and in acetone, practically insoluble in water. Glycerol phenylbutyrate is a nitrogen-binding agent. It is a triglyceride containing 3 molecules of PBA linked to a glycerol backbone, the chemical name of which is benzenebutanoic acid, 1', 1' ' –(1,2,3-propanetriyl) ester with a molecular weight of 530.67. It has a molecular formula of C33H38O6. The structural formula is."
},
{
"NDCCode": "0143-9476-25",
"PackageDescription": "25 AMPULE in 1 CARTON (0143-9476-25) / 1 mL in 1 AMPULE (0143-9476-01) ",
"NDC11Code": "00143-9476-25",
"ProductNDC": "0143-9476",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Epinephrine",
"NonProprietaryName": "Epinephrine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20260608",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA220562",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "EPINEPHRINE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260608",
"SamplePackage": "N",
"Description": "Epinephrine Injection, USP is a clear, colorless to slightly yellow sterile solution containing 1 mg/mL epinephrine. 1 mL Single-Dose Ampule. 1 mL single-dose clear glass ampule containing 1 mg/mL epinephrine as a sterile, non- pyrogenic, clear, colorless to slightly yellow solution. Each mL of Epinephrine Injection, USP solution contains 1 mg epinephrine, 8.6 mg sodium chloride, 0.2 mg sodium metabisulfite, hydrochloric acid as a dissolution agent and pH adjusting agent, and water for injection. The pH range is 2.2-5.0. Epinephrine is a sympathomimetic catecholamine. The chemical name of epinephrine is: 1,2-Benzenediol, 4-[(1R)-1-hydroxy-2-(methylamino)ethyl]-, or (-)-3,4-Dihydroxy-α-[2-(methylamino)ethyl]benzyl alcohol. The chemical structure of epinephrine is. The molecular weight of epinephrine is 183.2. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin."
},
{
"NDCCode": "0362-1200-50",
"PackageDescription": "50 CARTRIDGE in 1 CARTON (0362-1200-50) / 1.7 mL in 1 CARTRIDGE",
"NDC11Code": "00362-1200-50",
"ProductNDC": "0362-1200",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flavalta",
"NonProprietaryName": "Lidocaine Hydrochloride And Epinephrine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBMUCOSAL",
"StartMarketingDate": "20260319",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216564",
"LabelerName": "Septodont, Inc.",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE",
"StrengthNumber": "20; .01",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260319",
"SamplePackage": "N",
"IndicationAndUsage": "FLAVALTA solution is indicated for the production of local anesthesia for dental procedures by nerve block or infiltration techniques [see Dosage and Administration (2.2)].",
"Description": "FLAVALTA is a clear and colorless sterile isotonic solution containing a local anesthetic agent, Lidocaine Hydrochloride, and a vasoconstrictor, Epinephrine (as bitartrate) and is administered parenterally by injection. FLAVALTA is available in single dose cartridges of 1.7 mL [see Indications and Usage (1)]. FLAVALTA solution contains lidocaine hydrochloride which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-monohydrochloride, and has the following structural formula. C14H22N20 HCl H20 M.W. 288.8. Epinephrine is ( - )-3,4-Dihydroxy- α -[(Methylamino) methyl] benzyl alcohol and has the following structural formula. C9H13NO3 M.W. 183.21. Each mL of FLAVALTA contains 20 mg lidocaine hydrochloride (equivalent to 17.31 mg lidocaine), and 0.01 mg epinephrine (equivalent to 0.018 mg epinephrine bitartrate) with 0.25 mg edetate disodium, 1.2 mg potassium metabisulfite, 6.5 mg sodium chloride and 1 mL water for injections q.s. ad. The flavoring agents are 20.0 mg L-serine and 0.9 mg sodium saccharin. The pH of the FLAVALTA solution is adjusted with sodium hydroxide to 3.3 – 5.5."
},
{
"NDCCode": "0404-6500-15",
"PackageDescription": "50 CARTRIDGE in 1 CARTON (0404-6500-15) / 1.7 mL in 1 CARTRIDGE",
"NDC11Code": "00404-6500-15",
"ProductNDC": "0404-6500",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine",
"NonProprietaryName": "Lidocaine Hydrochloride And Epinephrine Bitartrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBMUCOSAL",
"StartMarketingDate": "20111107",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088389",
"LabelerName": "Henry Schein Inc.",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE",
"StrengthNumber": "20; .02",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20111107",
"SamplePackage": "N",
"IndicationAndUsage": "Lidocaine and Epinephrine Injection, USP is indicated for the production of local anesthesia for dental procedures by nerve block or infiltration techniques. Only accepted procedures for these techniques as described in standard textbooks are recommended.",
"Description": "Lidocaine Hydrochloride and Epinephrine, USP is a sterile isotonic solution containing a local anesthetic agent, Lidocaine Hydrochloride, and a vasoconstrictor, Epinephrine (as bitartrate) and are administered parenterally by injection. Both solutions are available in single dose cartridges of 1.7 mL (See INDICATIONS AND USAGE for specific uses). The solutions contain lidocaine hydrochloride which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-monohydrochloride, and has the following structural formula. C14H22N20 HCl H20 M.W. 288.8. Epinephrine is ( - )-3,4-Dihydroxy- -[(Methylamino) methyl] benzyl alcohol and has the following structural formula. C9H13NO3 M.W. 183.21. The pH of all solutions are adjusted to USP limits with Sodium Hydroxide or Hydrochloric Acid q.s. to adjust pH."
},
{
"NDCCode": "0404-6512-05",
"PackageDescription": "50 CARTRIDGE in 1 CARTON (0404-6512-05) / 1.7 mL in 1 CARTRIDGE",
"NDC11Code": "00404-6512-05",
"ProductNDC": "0404-6512",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine",
"NonProprietaryName": "Lidocaine Hydrochloride And Epinephrine Bitartrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBMUCOSAL",
"StartMarketingDate": "20111107",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088390",
"LabelerName": "Henry Schein Inc.",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE",
"StrengthNumber": "20; .01",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20111107",
"SamplePackage": "N",
"IndicationAndUsage": "Lidocaine and Epinephrine Injection, USP is indicated for the production of local anesthesia for dental procedures by nerve block or infiltration techniques. Only accepted procedures for these techniques as described in standard textbooks are recommended.",
"Description": "Lidocaine Hydrochloride and Epinephrine, USP is a sterile isotonic solution containing a local anesthetic agent, Lidocaine Hydrochloride, and a vasoconstrictor, Epinephrine (as bitartrate) and are administered parenterally by injection. Both solutions are available in single dose cartridges of 1.7 mL (See INDICATIONS AND USAGE for specific uses).The solutions contain lidocaine hydrochloride which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-monohydrochloride, and has the following structural formula. C14H22N20 HCl H20 M.W. 288.8. Epinephrine is ( - )-3,4-Dihydroxy-α-[(Methylamino) methyl] benzyl alcohol and has the following structural formula. C9H13NO3 M.W. 183.21. The pH of all solutions are adjusted to USP limits with Sodium Hydroxide or Hydrochloric Acid q.s. to adjust pH."
},
{
"NDCCode": "0404-9810-01",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 BAG (0404-9810-01) / 1 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "00404-9810-01",
"ProductNDC": "0404-9810",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adrenalin",
"NonProprietaryName": "Epineprine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20220107",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204200",
"LabelerName": "Henry Schein, Inc.",
"SubstanceName": "EPINEPHRINE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220107",
"SamplePackage": "N",
"IndicationAndUsage": "1.1 AnaphylaxisEmergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from insect stings or bites, foods, drugs, sera, diagnostic testing substances and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. 1.2 Hypotension associated with Septic ShockAdrenalin is indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.",
"Description": "Adrenalin (epinephrine injection, USP) is a clear, colorless, sterile solution containing 1 mg/mL epinephrine, packaged as 1 mL of solution in a single dose clear glass vial or 30 mL of solution in a multiple dose amber glass vial. In the 1 mL vial, each 1 mL of Adrenalin solution contains 1 mg epinephrine, 7.3 mg sodium chloride, 0.457 mg sodium metabisulfite, 1 mg sodium hydroxide, 2.25 mg tartaric acid, 0.20 mg disodium edetate dihydrate, 5.32 mg of 4% hydrochloric acid to adjust pH, and water for injection. In the 30 mL vial, each 1 mL of Adrenalin solution contains 1 mg epinephrine, 6.15 mg sodium chloride, 0.457 mg sodium metabisulfite, 0.920 mg sodium hydroxide, 2.25 mg tartaric acid, 0.20 mg disodium edetate dihydrate, 5.18 mg of 4% hydrochloric acid to adjust pH, 5.25 mg chlorobutanol as a preservative and water for injection. The pH range is 2.2-5.0. Epinephrine is a sympathomimetic catecholamine. The chemical name of epinephrine is: 1,2-Benzenediol, 4-[(1R)-1-hydroxy-2-(methylamino)ethyl]-, or (-)-3,4-Dihydroxy-α-[2-(methylamino)ethyl]benzyl alcohol. The chemical structure of epinephrine is. The molecular weight of epinephrine is 183.2. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin."
},
{
"NDCCode": "0517-3030-01",
"PackageDescription": "1 VIAL in 1 CARTON (0517-3030-01) / 1 mL in 1 VIAL",
"NDC11Code": "00517-3030-01",
"ProductNDC": "0517-3030",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Epinephrine",
"NonProprietaryName": "Epinephrine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20241009",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217192",
"LabelerName": "American Regent, Inc.",
"SubstanceName": "EPINEPHRINE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241009",
"SamplePackage": "N",
"IndicationAndUsage": "Epinephrine injection is a non-selective alpha and beta adrenergic agonist indicated for: 1 Emergency treatment of allergic reactions (Type 1), including anaphylaxis (1.1), 2 To increase mean arterial blood pressure in adult patients with hypotension associated with septic shock (1.2).",
"Description": "Epinephrine Injection, USP is a clear, colorless, sterile solution containing 1 mg/mL of epinephrine, packaged as 30 mL of solution in a multiple-dose amber glass vial for intravenous, intramuscular and subcutaneous use. Each 1 mL of Epinephrine solution contains 1 mg epinephrine, 9 mg sodium chloride, 0.457 mg sodium metabisulfite, q.s. with hydrochloric acid to adjust pH, 5.25 mg chlorobutanol as a preservative and water for injection. The pH range is 2.2 to 5.0. Epinephrine is a sympathomimetic catecholamine. The chemical name of epinephrine is: 1,2-Benzenediol, 4-[(1R)-1-hydroxy-2-(methylamino)ethyl]-, or (-)-3,4-Dihydroxy-α-[2-(methylamino)ethyl]benzyl alcohol. The chemical structure of epinephrine is. The molecular weight of epinephrine is 183.2. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin."
},
{
"NDCCode": "13630-0225-4",
"PackageDescription": "183 mL in 1 CAN (13630-0225-4) ",
"NDC11Code": "13630-0225-04",
"ProductNDC": "13630-0225",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aloe Up",
"ProprietaryNameSuffix": "Spf 50 C/s Sunscreen With Aloe Vera",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, And Octocrylene",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190522",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Prime Packaging Inc",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "25.41; 127.05; 42.35; 23.29",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-09-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190522",
"SamplePackage": "N"
},
{
"NDCCode": "16729-183-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (16729-183-01) ",
"NDC11Code": "16729-0183-01",
"ProductNDC": "16729-183",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrochlorothiazide",
"NonProprietaryName": "Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130410",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202556",
"LabelerName": "Accord Healthcare Inc.",
"SubstanceName": "HYDROCHLOROTHIAZIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2026-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130419",
"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 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 8CIN 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 12.5 mg, 25 mg or 50 mg hydrochlorothiazide, USP. In addition, each tablet contains the following inactive ingredients: dibasic calcium phosphate dihydrate, FD & C yellow, lactose monohydrate, magnesium stearate, pregelatinized starch (starch 1500) and sodium starch glycolate."
},
{
"NDCCode": "16729-183-17",
"PackageDescription": "1000 TABLET in 1 BOTTLE (16729-183-17) ",
"NDC11Code": "16729-0183-17",
"ProductNDC": "16729-183",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrochlorothiazide",
"NonProprietaryName": "Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130410",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202556",
"LabelerName": "Accord Healthcare Inc.",
"SubstanceName": "HYDROCHLOROTHIAZIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2026-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130410",
"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 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 8CIN 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 12.5 mg, 25 mg or 50 mg hydrochlorothiazide, USP. In addition, each tablet contains the following inactive ingredients: dibasic calcium phosphate dihydrate, FD & C yellow, lactose monohydrate, magnesium stearate, pregelatinized starch (starch 1500) and sodium starch glycolate."
},
{
"NDCCode": "24338-150-20",
"PackageDescription": "1 KIT in 1 CARTON (24338-150-20) * 2 mL in 1 VIAL * 2 mL in 1 SYRINGE, GLASS",
"NDC11Code": "24338-0150-20",
"ProductNDC": "24338-150",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triptodur",
"NonProprietaryName": "Triptorelin",
"DosageFormName": "KIT",
"StartMarketingDate": "20170908",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208956",
"LabelerName": "Azurity Pharmaceuticals, Inc.",
"Status": "Active",
"LastUpdate": "2025-09-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170908",
"SamplePackage": "N",
"IndicationAndUsage": "TRIPTODUR is indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty (CPP).",
"Description": "TRIPTODUR contains the pamoate salt of triptorelin, a synthetic decapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH or LHRH). The chemical name of triptorelin pamoate is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-tryptophyl-L-leucyl-L-arginyl-L-prolylglycine amide (pamoate salt). The molecular weight is 1699.9 and the structural formula is. TRIPTODUR for extended release injectable suspension for intramuscular use is provided as a sterile, lyophilized, biodegradable microgranule formulation in a single-dose vial, co-packaged with a syringe containing 2 mL Sterile Water for Injection for reconstitution of the lyophilisate. The triptorelin formulation is comprised of 22.5 mg triptorelin (equivalent to 31 mg triptorelin pamoate), carboxymethylcellulose sodium (26 mg), mannitol (74 mg), poly- d,l-lactide-co-glycolide (183 mg), and polysorbate 80 (1.7 mg). When 2 mL Sterile Water for Injection is added to the vial containing TRIPTODUR and mixed, a suspension is formed which is intended as a single intramuscular injection."
},
{
"NDCCode": "24357-811-20",
"PackageDescription": "1 KIT in 1 KIT (24357-811-20) * 1 mL in 1 VIAL, GLASS (42023-159-25) ",
"NDC11Code": "24357-0811-20",
"ProductNDC": "24357-811",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Epinephrinesnap-v",
"NonProprietaryName": "Epinephrine Convenience Kit",
"DosageFormName": "KIT",
"StartMarketingDate": "20170505",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "FOCUS HEALTH GROUP",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20170505",
"SamplePackage": "N",
"IndicationAndUsage": "Adrenalin® is available as a single-use 1 mL vial and a multiple-use 30 mL vial for intramuscular and subcutaneous use. Emergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from allergic reactions to insect stings, biting insects, foods, drugs, sera, diagnostic testing substances and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. The signs and symptoms associated with anaphylaxis include flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with hypotension, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, airway swelling, laryngospasm, bronchospasm, pruritus, urticaria or angioedema, swelling of the eyelids, lips, and tongue.",
"Description": "Adrenalin® (epinephrine injection, USP) is a clear, colorless, sterile solution containing 1 mg/mL (1:1000) epinephrine, packaged as 1 mL of solution in a singleuse clear glass vial or 30 mL of solution in a multiple-dose amber glass vial. In the 1 mL vial, each 1 mL of Adrenalin® solution contains 1 mg epinephrine, 7.3 mg sodium chloride, 0.457 mg sodium metabisulfite, 1 mg sodium hydroxide, 2.25 mg tartaric acid, 0.20 mg disodium edetate dihydrate, hydrochloric acid to adjust pH, and water for injection. In the 30 mL vial, each 1 mL of Adrenalin® solution contains 1 mg epinephrine, 6.15 mg sodium chloride, 0.457 mg sodium metabisulfite, 0.920 mg sodium hydroxide, 2.25 mg tartaric acid, 0.20 mg disodium edetate dihydrate, hydrochloric acid to adjust pH, 5.25 mg chlorobutanol as a preservative and water for injection. The pH range is 2.2-5.0. Epinephrine is a sympathomimetic catecholamine. The chemical name of epinephrine is: 1,2-Benzenediol, 4-[(1R)-1-hydroxy-2-(methylamino)ethyl]-, or (-)-3,4-Dihydroxy-α-[2-(methylamino)ethyl]benzyl alcohol. The chemical structure of epinephrine is:. The molecular weight of epinephrine is 183.2. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin."
},
{
"NDCCode": "25000-183-07",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (25000-183-07) ",
"NDC11Code": "25000-0183-07",
"ProductNDC": "25000-183",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216197",
"LabelerName": "MARKSANS PHARMA LIMITED",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2025-06-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220801",
"SamplePackage": "N",
"IndicationAndUsage": "Pregabalin capsules are indicated for. : 1 Neuropathic pain associated with diabetic peripheral neuropathy (DPN) (1), 2 Postherpetic neuralgia (PHN) (1), 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older (1), 4 Fibromyalgia (1), 5 Neuropathic pain associated with spinal cord injury (1).",
"Description": "Pregabalin, USP is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin, USP is. Pregabalin, USP is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin USP, along with pregelatinized starch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain iron oxide red and titanium dioxide and the white capsule shells contain titanium dioxide. Sodium Lauryl Sulfate (SLS) is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains shellac, black iron oxide and potassium hydroxide."
},
{
"NDCCode": "27241-183-30",
"PackageDescription": "30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (27241-183-30) ",
"NDC11Code": "27241-0183-30",
"ProductNDC": "27241-183",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20210119",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213271",
"LabelerName": "Ajanta Pharma USA Inc.",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210119",
"SamplePackage": "N",
"IndicationAndUsage": "Lamotrigine orally disintegrating tablets are indicated for. Epilepsy—adjunctive therapy in patients aged 2 years and older: 1 partial-onset seizures., 2 primary generalized tonic-clonic (PGTC) seizures., 3 generalized seizures of Lennox-Gastaut syndrome. (1.1).",
"Description": "Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine, USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine, USP is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. Lamotrigine orally disintegrating tablets, USP are supplied for oral administration. The tablets contain 25 mg (white to off-white), 50 mg (white to off-white), 100 mg (white to off-white), or 200 mg (white to off-white) of lamotrigine, USP and the following inactive ingredients: artificial peppermint flavor, croscarmellose sodium, microcrystalline cellulose, magnesium stearate, mannitol, colloidal silicon dioxide, pregelatinized starch and sucralose. Composition of peppermint flavor: Maize maltodextrin, modified corn starch and flavorings. Lamotrigine orally disintegrating tablets, USP are formulated using in-house technologies designed to mask the bitter taste of lamotrigine, USP. The formulation contains flavor and sweetener and has a good mouth feel, no grittiness, no after taste, better palatability and gives a rapid dissolution profile."
},
{
"NDCCode": "31722-183-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (31722-183-05) ",
"NDC11Code": "31722-0183-05",
"ProductNDC": "31722-183",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210922",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215414",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210922",
"SamplePackage": "N",
"Description": "Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate is a white crystalline powder with a bitter taste. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pre-gelatinized starch, hypromellose, sodium starch glycolate, magnesium stearate, titanium dioxide, polyethylene glycol. The 25 mg strength also contains polysorbate. The 50 mg strength also contains polysorbate, iron oxide yellow and iron oxide red. The 100 mg strength also contains polysorbate and iron oxide yellow. The 200 mg strength also contains iron oxide red. FDA approved tests Assay and related compounds differ from USP.FDA approved dissolution test specifications differ from USP."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>59651-183-25</NDCCode>
<PackageDescription>5 POUCH in 1 CARTON (59651-183-25) / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL</PackageDescription>
<NDC11Code>59651-0183-25</NDC11Code>
<ProductNDC>59651-183</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Albuterol Sulfate</ProprietaryName>
<NonProprietaryName>Albuterol Sulfate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20200420</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211888</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>ALBUTEROL SULFATE</SubstanceName>
<StrengthNumber>.63</StrengthNumber>
<StrengthUnit>mg/3mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200420</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Albuterol sulfate inhalation solution is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma (reversible obstructive airway disease).</IndicationAndUsage>
<Description>Albuterol sulfate inhalation solution is a sterile, clear, colorless solution of the sulfate salt of racemic albuterol, albuterol sulfate. Albuterol sulfate is a relatively selective beta 2-adrenergic bronchodilator (see CLINICAL PHARMACOLOGY). The chemical name for albuterol sulfate is α 1 [(tert-butylamino) methyl]-4-hydroxy-m-xylene-α,α’-diol sulfate (2:1) (salt), and its established chemical structure is as follows: The molecular weight of albuterol sulfate is 576.7 and the molecular formula is (C 13H 21NO 3) 2 H 2SO 4. Albuterol sulfate USP is a white or practically white powder, freely soluble in water, slightly soluble in alcohol, in ether and practically insoluble in chloroform. The World Health Organization recommended name for albuterol is salbutamol. Albuterol sulfate inhalation solution is supplied in two strengths in unit dose vials. Each unit dose vial contains either 0.63 mg of albuterol equivalent to 0.75 mg of albuterol sulfate or 1.25 mg of albuterol equivalent to 1.5 mg of albuterol sulfate with sodium chloride and sulfuric acid in a 3-mL isotonic, sterile, aqueous solution. Sodium chloride is added to adjust isotonicity of the solution and sulfuric acid is added to adjust pH of the solution to 3.5 (see HOW SUPPLIED). Albuterol sulfate inhalation solution does not require dilution prior to administration by nebulization. For albuterol sulfate inhalation solution, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari LC Plus TM nebulizer (with face mask or mouthpiece) connected to a Pari PRONEB TM compressor, under in vitro conditions, the mean delivered dose from the mouth piece (% nominal dose) was approximately 43% of albuterol (1.25 mg strength) and 39% of albuterol (0.63 mg strength) at a mean flow rate of 3.6 L/min. The mean nebulization time was 15 minutes or less. Albuterol sulfate inhalation solution should be administered from a jet nebulizer at an adequate flow rate, via a mouthpiece or face mask (see DOSAGE AND ADMINISTRATION).</Description>
</NDC>
<NDC>
<NDCCode>59651-183-30</NDCCode>
<PackageDescription>6 POUCH in 1 CARTON (59651-183-30) / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL</PackageDescription>
<NDC11Code>59651-0183-30</NDC11Code>
<ProductNDC>59651-183</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Albuterol Sulfate</ProprietaryName>
<NonProprietaryName>Albuterol Sulfate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20200420</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211888</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>ALBUTEROL SULFATE</SubstanceName>
<StrengthNumber>.63</StrengthNumber>
<StrengthUnit>mg/3mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240729</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Albuterol sulfate inhalation solution is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma (reversible obstructive airway disease).</IndicationAndUsage>
<Description>Albuterol sulfate inhalation solution is a sterile, clear, colorless solution of the sulfate salt of racemic albuterol, albuterol sulfate. Albuterol sulfate is a relatively selective beta 2-adrenergic bronchodilator (see CLINICAL PHARMACOLOGY). The chemical name for albuterol sulfate is α 1 [(tert-butylamino) methyl]-4-hydroxy-m-xylene-α,α’-diol sulfate (2:1) (salt), and its established chemical structure is as follows: The molecular weight of albuterol sulfate is 576.7 and the molecular formula is (C 13H 21NO 3) 2 H 2SO 4. Albuterol sulfate USP is a white or practically white powder, freely soluble in water, slightly soluble in alcohol, in ether and practically insoluble in chloroform. The World Health Organization recommended name for albuterol is salbutamol. Albuterol sulfate inhalation solution is supplied in two strengths in unit dose vials. Each unit dose vial contains either 0.63 mg of albuterol equivalent to 0.75 mg of albuterol sulfate or 1.25 mg of albuterol equivalent to 1.5 mg of albuterol sulfate with sodium chloride and sulfuric acid in a 3-mL isotonic, sterile, aqueous solution. Sodium chloride is added to adjust isotonicity of the solution and sulfuric acid is added to adjust pH of the solution to 3.5 (see HOW SUPPLIED). Albuterol sulfate inhalation solution does not require dilution prior to administration by nebulization. For albuterol sulfate inhalation solution, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari LC Plus TM nebulizer (with face mask or mouthpiece) connected to a Pari PRONEB TM compressor, under in vitro conditions, the mean delivered dose from the mouth piece (% nominal dose) was approximately 43% of albuterol (1.25 mg strength) and 39% of albuterol (0.63 mg strength) at a mean flow rate of 3.6 L/min. The mean nebulization time was 15 minutes or less. Albuterol sulfate inhalation solution should be administered from a jet nebulizer at an adequate flow rate, via a mouthpiece or face mask (see DOSAGE AND ADMINISTRATION).</Description>
</NDC>
<NDC>
<NDCCode>11489-183-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (11489-183-01) > 25 g in 1 TUBE</PackageDescription>
<NDC11Code>11489-0183-01</NDC11Code>
<ProductNDC>11489-183</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>No7 Protect And Perfect Intense Advanced Day Cream Spf 30</ProprietaryName>
<NonProprietaryName>Avobenzone, Octisalate, Octocrylene</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210914</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>BCM Ltd</LabelerName>
<SubstanceName>AVOBENZONE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>.75; 1.25; 1.875</StrengthNumber>
<StrengthUnit>g/25g; g/25g; g/25g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210914</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Directions. apply liberally 15 minutes before sun exposure. reapply at least every 2 hours. use a water resistant sunscreen if swimming or sweating. children under 6 months of age: Ask a doctor. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including. limit time in the sun, especially from 10 a.m - 2 p.m. wear long-sleeved shirts,pants,hats and sunglasses.</IndicationAndUsage>
<Description>No7 already perfect PROTECT & PERFECT COLLECTION. 25 ml e 0.84 Fl. Oz. The complete regime for fresher, younger looking skin. This collection visibly reduces the appearance of deep lines and wrinkles.</Description>
</NDC>
<NDC>
<NDCCode>12634-183-79</NDCCode>
<PackageDescription>25 CAPSULE in 1 BOTTLE (12634-183-79)</PackageDescription>
<NDC11Code>12634-0183-79</NDC11Code>
<ProductNDC>12634-183</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051109</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065271</ApplicationNumber>
<LabelerName>Apotheca Inc.</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Amoxicillin capsules are a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. : 1 Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. (1.1 – 1.4), 2 In combination for treatment of H. pylori infection and duodenal ulcer disease. (1.5).</IndicationAndUsage>
<Description>Formulation of amoxicillin capsules, USP contains amoxicillin, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as: The amoxicillin molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.45. Each capsule of amoxicillin with blue cap and pink body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The body of the 250 mg capsule is imprinted with ‘A44’ in black ink. The body of the 500 mg capsule is imprinted with ‘A45’ in black ink. Inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, and titanium dioxide. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>25021-183-67</NDCCode>
<PackageDescription>25 VIAL in 1 CARTON (25021-183-67) > 16 mL in 1 VIAL</PackageDescription>
<NDC11Code>25021-0183-67</NDC11Code>
<ProductNDC>25021-183</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefuroxime Sodium</ProprietaryName>
<NonProprietaryName>Cefuroxime Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20160901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064125</ApplicationNumber>
<LabelerName>Sagent Pharmaceuticals</LabelerName>
<SubstanceName>CEFUROXIME SODIUM</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>g/16mL</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cefuroxime for Injection, USP is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases: : 1 Lower Respiratory Tract Infections, including pneumonia, caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Klebsiella spp., Staphylococcus aureus (penicillinase- and non-penicillinase- producing strains), Streptococcus pyogenes, and Escherichia coli. , 2 Urinary Tract Infections caused by Escherichia coli and Klebsiella spp., 3 Skin and Skin Structure Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, Escherichia coli, Klebsiella spp., and Enterobacter spp. , 4 Septicemia caused by Staphylococcus aureus (penicillinase- and non-penicillinase- producing strains), Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae (including ampicillin-resistant strains), and Klebsiella spp., 5 Meningitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Neisseria meningitidis, and Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains). , 6 Gonorrhea: Uncomplicated and disseminated gonococcal infections due to Neisseria gonorrhoeae (penicillinase- and non-penicillinase-producing strains) in both males and females. , 7 Bone and Joint Infections caused by Staphylococcus aureus (penicillinase- and non- penicillinase-producing strains). .</IndicationAndUsage>
<Description>Cefuroxime is a semisynthetic, broad-spectrum, cephalosporin antibiotic for parenteral administration. It is the sodium salt of (6R,7R)-3-carbamoyloxymethyl-7-[Z-2-methoxyimino-2-(fur-2-yl) acetamido] ceph-3-em-4-carboxylate, and it has the following chemical structure:. The empirical formula is C16H15N4NaO8S, representing a molecular weight of 446.4. Cefuroxime for Injection, USP contains approximately 54.2 mg (2.4 mEq) of sodium per gram of cefuroxime activity. Cefuroxime for Injection, USP in sterile crystalline form is supplied in vials equivalent to 750 mg or 1.5 g of cefuroxime as cefuroxime sodium. Solutions of Cefuroxime for Injection, USP range in color from light yellow to amber, depending on the concentration and diluent used. The pH of freshly constituted solutions usually ranges from 6 to 8.5.</Description>
</NDC>
<NDC>
<NDCCode>64220-183-08</NDCCode>
<PackageDescription>25 kg in 1 DRUM (64220-183-08) </PackageDescription>
<NDC11Code>64220-0183-08</NDC11Code>
<ProductNDC>64220-183</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20210501</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2021-06-10</LastUpdate>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-MAY-21</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>76150-183-32</NDCCode>
<PackageDescription>4.25 g in 1 TUBE (76150-183-32)</PackageDescription>
<NDC11Code>76150-0183-32</NDC11Code>
<ProductNDC>76150-183</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mineral Lip Bonfire</ProprietaryName>
<ProprietaryNameSuffix>Spf 30 Broad Spectrum</ProprietaryNameSuffix>
<NonProprietaryName>Sunscreen</NonProprietaryName>
<DosageFormName>LIPSTICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Bell International Laboratories, Inc.</LabelerName>
<SubstanceName>ZINC OXIDE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>1.4; 2.8</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>84603-183-01</NDCCode>
<PackageDescription>4.25 g in 1 TUBE (84603-183-01) </PackageDescription>
<NDC11Code>84603-0183-01</NDC11Code>
<ProductNDC>84603-183</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Basin Lime Sugar Spf 15 Broad Spectrum Sunscreen Lip Balm</ProprietaryName>
<NonProprietaryName>Avobenzone, Octinoxate, Octisalate, Octocrylene</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220210</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Retail Concepts of Minnesota, Inc.</LabelerName>
<SubstanceName>OCTINOXATE; AVOBENZONE; OCTOCRYLENE; OCTISALATE</SubstanceName>
<StrengthNumber>7.5; 3; 5; 5</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g; g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Usehelps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59651-184-25</NDCCode>
<PackageDescription>5 POUCH in 1 CARTON (59651-184-25) / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL</PackageDescription>
<NDC11Code>59651-0184-25</NDC11Code>
<ProductNDC>59651-184</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Albuterol Sulfate</ProprietaryName>
<NonProprietaryName>Albuterol Sulfate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20200420</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211888</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>ALBUTEROL SULFATE</SubstanceName>
<StrengthNumber>1.25</StrengthNumber>
<StrengthUnit>mg/3mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200420</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Albuterol sulfate inhalation solution is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma (reversible obstructive airway disease).</IndicationAndUsage>
<Description>Albuterol sulfate inhalation solution is a sterile, clear, colorless solution of the sulfate salt of racemic albuterol, albuterol sulfate. Albuterol sulfate is a relatively selective beta 2-adrenergic bronchodilator (see CLINICAL PHARMACOLOGY). The chemical name for albuterol sulfate is α 1 [(tert-butylamino) methyl]-4-hydroxy-m-xylene-α,α’-diol sulfate (2:1) (salt), and its established chemical structure is as follows: The molecular weight of albuterol sulfate is 576.7 and the molecular formula is (C 13H 21NO 3) 2 H 2SO 4. Albuterol sulfate USP is a white or practically white powder, freely soluble in water, slightly soluble in alcohol, in ether and practically insoluble in chloroform. The World Health Organization recommended name for albuterol is salbutamol. Albuterol sulfate inhalation solution is supplied in two strengths in unit dose vials. Each unit dose vial contains either 0.63 mg of albuterol equivalent to 0.75 mg of albuterol sulfate or 1.25 mg of albuterol equivalent to 1.5 mg of albuterol sulfate with sodium chloride and sulfuric acid in a 3-mL isotonic, sterile, aqueous solution. Sodium chloride is added to adjust isotonicity of the solution and sulfuric acid is added to adjust pH of the solution to 3.5 (see HOW SUPPLIED). Albuterol sulfate inhalation solution does not require dilution prior to administration by nebulization. For albuterol sulfate inhalation solution, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari LC Plus TM nebulizer (with face mask or mouthpiece) connected to a Pari PRONEB TM compressor, under in vitro conditions, the mean delivered dose from the mouth piece (% nominal dose) was approximately 43% of albuterol (1.25 mg strength) and 39% of albuterol (0.63 mg strength) at a mean flow rate of 3.6 L/min. The mean nebulization time was 15 minutes or less. Albuterol sulfate inhalation solution should be administered from a jet nebulizer at an adequate flow rate, via a mouthpiece or face mask (see DOSAGE AND ADMINISTRATION).</Description>
</NDC>
<NDC>
<NDCCode>59651-273-25</NDCCode>
<PackageDescription>250 CAPSULE in 1 BOTTLE (59651-273-25) </PackageDescription>
<NDC11Code>59651-0273-25</NDC11Code>
<ProductNDC>59651-273</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prazosin Hydrochloride</ProprietaryName>
<NonProprietaryName>Prazosin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230331</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213052</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>PRAZOSIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-04-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230331</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Prazosin hydrochloride capsules are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Prazosin hydrochloride capsules can be used alone or in combination with other antihypertensive drugs such as diuretics or beta-adrenergic blocking agents.</IndicationAndUsage>
<Description>Prazosin hydrochloride, a quinazoline derivative, is the first of a new chemical class of antihypertensives. It is the hydrochloride salt of 1-(4-amino-6, 7-dimethoxy-2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is. Molecular formula C19H21N5O4.HCl. It is a white or almost white crystalline powder, very slightly soluble in water, slightly soluble in alcohol and methanol, practically insoluble in acetone and has a molecular weight of 419.87. Each 1 mg capsule of prazosin hydrochloride USP, for oral use contains drug equivalent to 1 mg free base. Prazosin hydrochloride capsules USP contains the following inactive ingredients: corn starch, magnesium stearate, sodium lauryl sulfate, sucrose. The hard gelatin capsules contain gelatin and titanium dioxide. In addition, the 1 mg hard gelatin capsules contain D&C Yellow 10 and FD&C Yellow 6; the 2 mg hard gelatin capsules contain D&C Yellow 10, FD&C Blue 1, FD&C Red 3 and FD&C Yellow 6; the 5 mg hard gelatin capsules contains D&C Yellow 10, FD&C Blue 1, FD&C Red 3 and FD&C Yellow 6. The capsule shells are imprinted with black ink which contains black iron oxide, potassium hydroxide and shellac. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>59651-339-25</NDCCode>
<PackageDescription>2500 TABLET, FILM COATED in 1 BAG (59651-339-25) </PackageDescription>
<NDC11Code>59651-0339-25</NDC11Code>
<ProductNDC>59651-339</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<StartMarketingDate>20200501</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>MINOCYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2021-11-18</LastUpdate>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-MAY-20</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>59651-548-25</NDCCode>
<PackageDescription>25000 TABLET, EXTENDED RELEASE in 1 BAG (59651-548-25) </PackageDescription>
<NDC11Code>59651-0548-25</NDC11Code>
<ProductNDC>59651-548</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<StartMarketingDate>20240415</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-05-07</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>15-APR-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>59651-562-25</NDCCode>
<PackageDescription>25000 CAPSULE, DELAYED RELEASE in 1 BAG (59651-562-25) </PackageDescription>
<NDC11Code>59651-0562-25</NDC11Code>
<ProductNDC>59651-562</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<StartMarketingDate>20231120</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>ESOMEPRAZOLE MAGNESIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-12-28</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20-NOV-23</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>59651-658-04</NDCCode>
<PackageDescription>4 BOTTLE in 1 CARTON (59651-658-04) / 25 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>59651-0658-04</NDC11Code>
<ProductNDC>59651-658</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitroglycerin</ProprietaryName>
<NonProprietaryName>Nitroglycerin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20231026</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217879</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>NITROGLYCERIN</SubstanceName>
<StrengthNumber>.4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231026</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nitroglycerin sublingual tablets are indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.</IndicationAndUsage>
<Description>Nitroglycerin is a stabilized sublingual compressed nitroglycerin tablet that contains 0.3 mg, 0.4 mg, or 0.6 mg nitroglycerin; as well as calcium stearate, colloidal silicon dioxide, glyceryl monostearate, hydrophobic colloidal silica, lactose monohydrate, magnesium stearate and pregelatinized starch (maize). Nitroglycerin, an organic nitrate, is a vasodilating agent. The chemical name for nitroglycerin is 1, 2, 3 propanetriol trinitrate and the chemical structure is:. Molecular weight: 227.09.</Description>
</NDC>
<NDC>
<NDCCode>59651-876-25</NDCCode>
<PackageDescription>25000 g in 1 BAG (59651-876-25) </PackageDescription>
<NDC11Code>59651-0876-25</NDC11Code>
<ProductNDC>59651-876</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Polyethylene Glycol 3350</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<StartMarketingDate>20240423</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>POLYETHYLENE GLYCOL 3350</SubstanceName>
<StrengthNumber>17</StrengthNumber>
<StrengthUnit>g/17g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-03-26</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>23-APR-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>59651-988-25</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (59651-988-25) / 25 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>59651-0988-25</NDC11Code>
<ProductNDC>59651-988</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glycerol Phenylbutyrate</ProprietaryName>
<NonProprietaryName>Glycerol Phenylbutyrate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260415</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA220313</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>GLYCEROL PHENYLBUTYRATE</SubstanceName>
<StrengthNumber>1.1</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glycerol phenylbutyrate oral liquid is indicated for use as a nitrogen-binding agent for chronic management of patients with urea cycle disorders (UCDs) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. Glycerol phenylbutyrate oral liquid must be used with dietary protein restriction and, in some cases, dietary supplements (e.g., essential amino acids, arginine, citrulline, protein-free calorie supplements). Limitations of Use: 1 Glycerol phenylbutyrate oral liquid is not indicated for the treatment of acute hyperammonemia in patients with UCDs because more rapidly acting interventions are essential to reduce plasma ammonia levels., 2 The safety and efficacy of glycerol phenylbutyrate oral liquid for the treatment of N-acetylglutamate synthase (NAGS) deficiency has not been established.</IndicationAndUsage>
<Description>Glycerol phenylbutyrate is a clear, colorless to pale yellow oral liquid. It is freely soluble in toluene and in acetone, practically insoluble in water. Glycerol phenylbutyrate is a nitrogen-binding agent. It is a triglyceride containing 3 molecules of PBA linked to a glycerol backbone, the chemical name of which is benzenebutanoic acid, 1', 1' ' –(1,2,3-propanetriyl) ester with a molecular weight of 530.67. It has a molecular formula of C33H38O6. The structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>0143-9476-25</NDCCode>
<PackageDescription>25 AMPULE in 1 CARTON (0143-9476-25) / 1 mL in 1 AMPULE (0143-9476-01) </PackageDescription>
<NDC11Code>00143-9476-25</NDC11Code>
<ProductNDC>0143-9476</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epinephrine</ProprietaryName>
<NonProprietaryName>Epinephrine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20260608</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA220562</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>EPINEPHRINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260608</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Epinephrine Injection, USP is a clear, colorless to slightly yellow sterile solution containing 1 mg/mL epinephrine. 1 mL Single-Dose Ampule. 1 mL single-dose clear glass ampule containing 1 mg/mL epinephrine as a sterile, non- pyrogenic, clear, colorless to slightly yellow solution. Each mL of Epinephrine Injection, USP solution contains 1 mg epinephrine, 8.6 mg sodium chloride, 0.2 mg sodium metabisulfite, hydrochloric acid as a dissolution agent and pH adjusting agent, and water for injection. The pH range is 2.2-5.0. Epinephrine is a sympathomimetic catecholamine. The chemical name of epinephrine is: 1,2-Benzenediol, 4-[(1R)-1-hydroxy-2-(methylamino)ethyl]-, or (-)-3,4-Dihydroxy-α-[2-(methylamino)ethyl]benzyl alcohol. The chemical structure of epinephrine is. The molecular weight of epinephrine is 183.2. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin.</Description>
</NDC>
<NDC>
<NDCCode>0362-1200-50</NDCCode>
<PackageDescription>50 CARTRIDGE in 1 CARTON (0362-1200-50) / 1.7 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>00362-1200-50</NDC11Code>
<ProductNDC>0362-1200</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Flavalta</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride And Epinephrine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBMUCOSAL</RouteName>
<StartMarketingDate>20260319</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216564</ApplicationNumber>
<LabelerName>Septodont, Inc.</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE</SubstanceName>
<StrengthNumber>20; .01</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260319</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FLAVALTA solution is indicated for the production of local anesthesia for dental procedures by nerve block or infiltration techniques [see Dosage and Administration (2.2)].</IndicationAndUsage>
<Description>FLAVALTA is a clear and colorless sterile isotonic solution containing a local anesthetic agent, Lidocaine Hydrochloride, and a vasoconstrictor, Epinephrine (as bitartrate) and is administered parenterally by injection. FLAVALTA is available in single dose cartridges of 1.7 mL [see Indications and Usage (1)]. FLAVALTA solution contains lidocaine hydrochloride which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-monohydrochloride, and has the following structural formula. C14H22N20 HCl H20 M.W. 288.8. Epinephrine is ( - )-3,4-Dihydroxy- α -[(Methylamino) methyl] benzyl alcohol and has the following structural formula. C9H13NO3 M.W. 183.21. Each mL of FLAVALTA contains 20 mg lidocaine hydrochloride (equivalent to 17.31 mg lidocaine), and 0.01 mg epinephrine (equivalent to 0.018 mg epinephrine bitartrate) with 0.25 mg edetate disodium, 1.2 mg potassium metabisulfite, 6.5 mg sodium chloride and 1 mL water for injections q.s. ad. The flavoring agents are 20.0 mg L-serine and 0.9 mg sodium saccharin. The pH of the FLAVALTA solution is adjusted with sodium hydroxide to 3.3 – 5.5.</Description>
</NDC>
<NDC>
<NDCCode>0404-6500-15</NDCCode>
<PackageDescription>50 CARTRIDGE in 1 CARTON (0404-6500-15) / 1.7 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>00404-6500-15</NDC11Code>
<ProductNDC>0404-6500</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride And Epinephrine Bitartrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBMUCOSAL</RouteName>
<StartMarketingDate>20111107</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088389</ApplicationNumber>
<LabelerName>Henry Schein Inc.</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE</SubstanceName>
<StrengthNumber>20; .02</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocaine and Epinephrine Injection, USP is indicated for the production of local anesthesia for dental procedures by nerve block or infiltration techniques. Only accepted procedures for these techniques as described in standard textbooks are recommended.</IndicationAndUsage>
<Description>Lidocaine Hydrochloride and Epinephrine, USP is a sterile isotonic solution containing a local anesthetic agent, Lidocaine Hydrochloride, and a vasoconstrictor, Epinephrine (as bitartrate) and are administered parenterally by injection. Both solutions are available in single dose cartridges of 1.7 mL (See INDICATIONS AND USAGE for specific uses). The solutions contain lidocaine hydrochloride which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-monohydrochloride, and has the following structural formula. C14H22N20 HCl H20 M.W. 288.8. Epinephrine is ( - )-3,4-Dihydroxy- -[(Methylamino) methyl] benzyl alcohol and has the following structural formula. C9H13NO3 M.W. 183.21. The pH of all solutions are adjusted to USP limits with Sodium Hydroxide or Hydrochloric Acid q.s. to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>0404-6512-05</NDCCode>
<PackageDescription>50 CARTRIDGE in 1 CARTON (0404-6512-05) / 1.7 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>00404-6512-05</NDC11Code>
<ProductNDC>0404-6512</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride And Epinephrine Bitartrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBMUCOSAL</RouteName>
<StartMarketingDate>20111107</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088390</ApplicationNumber>
<LabelerName>Henry Schein Inc.</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE</SubstanceName>
<StrengthNumber>20; .01</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocaine and Epinephrine Injection, USP is indicated for the production of local anesthesia for dental procedures by nerve block or infiltration techniques. Only accepted procedures for these techniques as described in standard textbooks are recommended.</IndicationAndUsage>
<Description>Lidocaine Hydrochloride and Epinephrine, USP is a sterile isotonic solution containing a local anesthetic agent, Lidocaine Hydrochloride, and a vasoconstrictor, Epinephrine (as bitartrate) and are administered parenterally by injection. Both solutions are available in single dose cartridges of 1.7 mL (See INDICATIONS AND USAGE for specific uses).The solutions contain lidocaine hydrochloride which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-monohydrochloride, and has the following structural formula. C14H22N20 HCl H20 M.W. 288.8. Epinephrine is ( - )-3,4-Dihydroxy-α-[(Methylamino) methyl] benzyl alcohol and has the following structural formula. C9H13NO3 M.W. 183.21. The pH of all solutions are adjusted to USP limits with Sodium Hydroxide or Hydrochloric Acid q.s. to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>0404-9810-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 BAG (0404-9810-01) / 1 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>00404-9810-01</NDC11Code>
<ProductNDC>0404-9810</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Adrenalin</ProprietaryName>
<NonProprietaryName>Epineprine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20220107</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204200</ApplicationNumber>
<LabelerName>Henry Schein, Inc.</LabelerName>
<SubstanceName>EPINEPHRINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1.1 AnaphylaxisEmergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from insect stings or bites, foods, drugs, sera, diagnostic testing substances and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. 1.2 Hypotension associated with Septic ShockAdrenalin is indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.</IndicationAndUsage>
<Description>Adrenalin (epinephrine injection, USP) is a clear, colorless, sterile solution containing 1 mg/mL epinephrine, packaged as 1 mL of solution in a single dose clear glass vial or 30 mL of solution in a multiple dose amber glass vial. In the 1 mL vial, each 1 mL of Adrenalin solution contains 1 mg epinephrine, 7.3 mg sodium chloride, 0.457 mg sodium metabisulfite, 1 mg sodium hydroxide, 2.25 mg tartaric acid, 0.20 mg disodium edetate dihydrate, 5.32 mg of 4% hydrochloric acid to adjust pH, and water for injection. In the 30 mL vial, each 1 mL of Adrenalin solution contains 1 mg epinephrine, 6.15 mg sodium chloride, 0.457 mg sodium metabisulfite, 0.920 mg sodium hydroxide, 2.25 mg tartaric acid, 0.20 mg disodium edetate dihydrate, 5.18 mg of 4% hydrochloric acid to adjust pH, 5.25 mg chlorobutanol as a preservative and water for injection. The pH range is 2.2-5.0. Epinephrine is a sympathomimetic catecholamine. The chemical name of epinephrine is: 1,2-Benzenediol, 4-[(1R)-1-hydroxy-2-(methylamino)ethyl]-, or (-)-3,4-Dihydroxy-α-[2-(methylamino)ethyl]benzyl alcohol. The chemical structure of epinephrine is. The molecular weight of epinephrine is 183.2. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin.</Description>
</NDC>
<NDC>
<NDCCode>0517-3030-01</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (0517-3030-01) / 1 mL in 1 VIAL</PackageDescription>
<NDC11Code>00517-3030-01</NDC11Code>
<ProductNDC>0517-3030</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epinephrine</ProprietaryName>
<NonProprietaryName>Epinephrine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20241009</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217192</ApplicationNumber>
<LabelerName>American Regent, Inc.</LabelerName>
<SubstanceName>EPINEPHRINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241009</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Epinephrine injection is a non-selective alpha and beta adrenergic agonist indicated for: 1 Emergency treatment of allergic reactions (Type 1), including anaphylaxis (1.1), 2 To increase mean arterial blood pressure in adult patients with hypotension associated with septic shock (1.2).</IndicationAndUsage>
<Description>Epinephrine Injection, USP is a clear, colorless, sterile solution containing 1 mg/mL of epinephrine, packaged as 30 mL of solution in a multiple-dose amber glass vial for intravenous, intramuscular and subcutaneous use. Each 1 mL of Epinephrine solution contains 1 mg epinephrine, 9 mg sodium chloride, 0.457 mg sodium metabisulfite, q.s. with hydrochloric acid to adjust pH, 5.25 mg chlorobutanol as a preservative and water for injection. The pH range is 2.2 to 5.0. Epinephrine is a sympathomimetic catecholamine. The chemical name of epinephrine is: 1,2-Benzenediol, 4-[(1R)-1-hydroxy-2-(methylamino)ethyl]-, or (-)-3,4-Dihydroxy-α-[2-(methylamino)ethyl]benzyl alcohol. The chemical structure of epinephrine is. The molecular weight of epinephrine is 183.2. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin.</Description>
</NDC>
<NDC>
<NDCCode>13630-0225-4</NDCCode>
<PackageDescription>183 mL in 1 CAN (13630-0225-4) </PackageDescription>
<NDC11Code>13630-0225-04</NDC11Code>
<ProductNDC>13630-0225</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aloe Up</ProprietaryName>
<ProprietaryNameSuffix>Spf 50 C/s Sunscreen With Aloe Vera</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, And Octocrylene</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190522</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Prime Packaging Inc</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>25.41; 127.05; 42.35; 23.29</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-09-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190522</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>16729-183-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (16729-183-01) </PackageDescription>
<NDC11Code>16729-0183-01</NDC11Code>
<ProductNDC>16729-183</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130410</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202556</ApplicationNumber>
<LabelerName>Accord Healthcare 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>2026-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130419</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 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 8CIN 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 12.5 mg, 25 mg or 50 mg hydrochlorothiazide, USP. In addition, each tablet contains the following inactive ingredients: dibasic calcium phosphate dihydrate, FD & C yellow, lactose monohydrate, magnesium stearate, pregelatinized starch (starch 1500) and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>16729-183-17</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (16729-183-17) </PackageDescription>
<NDC11Code>16729-0183-17</NDC11Code>
<ProductNDC>16729-183</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130410</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202556</ApplicationNumber>
<LabelerName>Accord Healthcare 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>2026-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130410</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 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 8CIN 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 12.5 mg, 25 mg or 50 mg hydrochlorothiazide, USP. In addition, each tablet contains the following inactive ingredients: dibasic calcium phosphate dihydrate, FD & C yellow, lactose monohydrate, magnesium stearate, pregelatinized starch (starch 1500) and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>24338-150-20</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (24338-150-20) * 2 mL in 1 VIAL * 2 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>24338-0150-20</NDC11Code>
<ProductNDC>24338-150</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triptodur</ProprietaryName>
<NonProprietaryName>Triptorelin</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20170908</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208956</ApplicationNumber>
<LabelerName>Azurity Pharmaceuticals, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-09-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170908</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TRIPTODUR is indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty (CPP).</IndicationAndUsage>
<Description>TRIPTODUR contains the pamoate salt of triptorelin, a synthetic decapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH or LHRH). The chemical name of triptorelin pamoate is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-tryptophyl-L-leucyl-L-arginyl-L-prolylglycine amide (pamoate salt). The molecular weight is 1699.9 and the structural formula is. TRIPTODUR for extended release injectable suspension for intramuscular use is provided as a sterile, lyophilized, biodegradable microgranule formulation in a single-dose vial, co-packaged with a syringe containing 2 mL Sterile Water for Injection for reconstitution of the lyophilisate. The triptorelin formulation is comprised of 22.5 mg triptorelin (equivalent to 31 mg triptorelin pamoate), carboxymethylcellulose sodium (26 mg), mannitol (74 mg), poly- d,l-lactide-co-glycolide (183 mg), and polysorbate 80 (1.7 mg). When 2 mL Sterile Water for Injection is added to the vial containing TRIPTODUR and mixed, a suspension is formed which is intended as a single intramuscular injection.</Description>
</NDC>
<NDC>
<NDCCode>24357-811-20</NDCCode>
<PackageDescription>1 KIT in 1 KIT (24357-811-20) * 1 mL in 1 VIAL, GLASS (42023-159-25) </PackageDescription>
<NDC11Code>24357-0811-20</NDC11Code>
<ProductNDC>24357-811</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epinephrinesnap-v</ProprietaryName>
<NonProprietaryName>Epinephrine Convenience Kit</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20170505</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>FOCUS HEALTH GROUP</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170505</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adrenalin® is available as a single-use 1 mL vial and a multiple-use 30 mL vial for intramuscular and subcutaneous use. Emergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from allergic reactions to insect stings, biting insects, foods, drugs, sera, diagnostic testing substances and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. The signs and symptoms associated with anaphylaxis include flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with hypotension, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, airway swelling, laryngospasm, bronchospasm, pruritus, urticaria or angioedema, swelling of the eyelids, lips, and tongue.</IndicationAndUsage>
<Description>Adrenalin® (epinephrine injection, USP) is a clear, colorless, sterile solution containing 1 mg/mL (1:1000) epinephrine, packaged as 1 mL of solution in a singleuse clear glass vial or 30 mL of solution in a multiple-dose amber glass vial. In the 1 mL vial, each 1 mL of Adrenalin® solution contains 1 mg epinephrine, 7.3 mg sodium chloride, 0.457 mg sodium metabisulfite, 1 mg sodium hydroxide, 2.25 mg tartaric acid, 0.20 mg disodium edetate dihydrate, hydrochloric acid to adjust pH, and water for injection. In the 30 mL vial, each 1 mL of Adrenalin® solution contains 1 mg epinephrine, 6.15 mg sodium chloride, 0.457 mg sodium metabisulfite, 0.920 mg sodium hydroxide, 2.25 mg tartaric acid, 0.20 mg disodium edetate dihydrate, hydrochloric acid to adjust pH, 5.25 mg chlorobutanol as a preservative and water for injection. The pH range is 2.2-5.0. Epinephrine is a sympathomimetic catecholamine. The chemical name of epinephrine is: 1,2-Benzenediol, 4-[(1R)-1-hydroxy-2-(methylamino)ethyl]-, or (-)-3,4-Dihydroxy-α-[2-(methylamino)ethyl]benzyl alcohol. The chemical structure of epinephrine is:. The molecular weight of epinephrine is 183.2. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin.</Description>
</NDC>
<NDC>
<NDCCode>25000-183-07</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (25000-183-07) </PackageDescription>
<NDC11Code>25000-0183-07</NDC11Code>
<ProductNDC>25000-183</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216197</ApplicationNumber>
<LabelerName>MARKSANS PHARMA LIMITED</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-06-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pregabalin capsules are indicated for. : 1 Neuropathic pain associated with diabetic peripheral neuropathy (DPN) (1), 2 Postherpetic neuralgia (PHN) (1), 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older (1), 4 Fibromyalgia (1), 5 Neuropathic pain associated with spinal cord injury (1).</IndicationAndUsage>
<Description>Pregabalin, USP is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin, USP is. Pregabalin, USP is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin USP, along with pregelatinized starch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain iron oxide red and titanium dioxide and the white capsule shells contain titanium dioxide. Sodium Lauryl Sulfate (SLS) is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains shellac, black iron oxide and potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>27241-183-30</NDCCode>
<PackageDescription>30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (27241-183-30) </PackageDescription>
<NDC11Code>27241-0183-30</NDC11Code>
<ProductNDC>27241-183</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210119</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213271</ApplicationNumber>
<LabelerName>Ajanta Pharma USA Inc.</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210119</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lamotrigine orally disintegrating tablets are indicated for. Epilepsy—adjunctive therapy in patients aged 2 years and older: 1 partial-onset seizures., 2 primary generalized tonic-clonic (PGTC) seizures., 3 generalized seizures of Lennox-Gastaut syndrome. (1.1).</IndicationAndUsage>
<Description>Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine, USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine, USP is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. Lamotrigine orally disintegrating tablets, USP are supplied for oral administration. The tablets contain 25 mg (white to off-white), 50 mg (white to off-white), 100 mg (white to off-white), or 200 mg (white to off-white) of lamotrigine, USP and the following inactive ingredients: artificial peppermint flavor, croscarmellose sodium, microcrystalline cellulose, magnesium stearate, mannitol, colloidal silicon dioxide, pregelatinized starch and sucralose. Composition of peppermint flavor: Maize maltodextrin, modified corn starch and flavorings. Lamotrigine orally disintegrating tablets, USP are formulated using in-house technologies designed to mask the bitter taste of lamotrigine, USP. The formulation contains flavor and sweetener and has a good mouth feel, no grittiness, no after taste, better palatability and gives a rapid dissolution profile.</Description>
</NDC>
<NDC>
<NDCCode>31722-183-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (31722-183-05) </PackageDescription>
<NDC11Code>31722-0183-05</NDC11Code>
<ProductNDC>31722-183</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210922</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215414</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210922</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate is a white crystalline powder with a bitter taste. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pre-gelatinized starch, hypromellose, sodium starch glycolate, magnesium stearate, titanium dioxide, polyethylene glycol. The 25 mg strength also contains polysorbate. The 50 mg strength also contains polysorbate, iron oxide yellow and iron oxide red. The 100 mg strength also contains polysorbate and iron oxide yellow. The 200 mg strength also contains iron oxide red. FDA approved tests Assay and related compounds differ from USP.FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
</NDCList>