{
"NDC": [
{
"NDCCode": "17478-519-19",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (17478-519-19) > 3 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "17478-0519-19",
"ProductNDC": "17478-519",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Moxifloxacin",
"NonProprietaryName": "Moxifloxacin",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20171109",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202916",
"LabelerName": "Akorn",
"SubstanceName": "MOXIFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Quinolone Antimicrobial [EPC], Quinolones [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20171109",
"SamplePackage": "N",
"IndicationAndUsage": "Moxifloxacin Ophthalmic Solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:. Corynebacterium species*. Micrococcus luteus*. Staphylococcus aureus. Staphylococcus epidermidis. Staphylococcus haemolyticus. Staphylococcus hominis. Staphylococcus warneri*. Streptococcus pneumoniae. Streptococcus viridans group. Acinetobacter lwoffii*. Haemophilus influenzae. Haemophilus parainfluenzae*. Chlamydia trachomatis. *Efficacy for this organism was studied in fewer than 10 infections.",
"Description": "Moxifloxacin Ophthalmic Solution, USP 0.5% is a sterile solution for topical ophthalmic use. Moxifloxacin hydrochloride is an 8-methoxy fluoroquinolone anti-infective, with a diazabicyclononyl ring at the C7 position. The chemical name for moxifloxacin hydrochloride 1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-[(4aS,7aS)-octahydro-6H-pyrrolol[3,4-b] pyridin-6-yl]-4-oxo-3-quinolinecarboxylic acid, monohydrochloride. The molecular formula for moxifloxacin hydrochloride is C12H24FN3O4HCl and its molecular weight is 437.9 g/mol. The chemical structure is presented below:. Moxifloxacin hydrochloride is a slightly yellow to yellow crystalline powder. Each mL of Moxifloxacin Ophthalmic Solution, USP contains 5.45 mg moxifloxacin hydrochloride, equivalent to 5 mg moxifloxacin base. Moxifloxacin Ophthalmic Solution contains Active: Moxifloxacin 0.5% (5 mg/mL); Inactives: Boric acid, sodium chloride, and water for injection. May also contain hydrochloric acid/sodium hydroxide to adjust pH to approximately 6.8. Moxifloxacin Ophthalmic Solution, USP is an isotonic solution with an osmolality of approximately 290 mOsm/kg."
},
{
"NDCCode": "63940-519-19",
"PackageDescription": "1 BOTTLE in 1 PACKAGE (63940-519-19) > 8 TABLET in 1 BOTTLE",
"NDC11Code": "63940-0519-19",
"ProductNDC": "63940-519",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pain Reliever",
"ProprietaryNameSuffix": "Extra Strength",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20040510",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "Harmon Store Inc.",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-05-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20040510",
"SamplePackage": "N"
},
{
"NDCCode": "17478-209-19",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (17478-209-19) > 3 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "17478-0209-19",
"ProductNDC": "17478-209",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketorolac Tromethamine",
"NonProprietaryName": "Ketorolac Tromethamine",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20091105",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078434",
"LabelerName": "Akorn",
"SubstanceName": "KETOROLAC TROMETHAMINE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20091105",
"SamplePackage": "N",
"IndicationAndUsage": "Ketorolac tromethamine ophthalmic solution is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. Ketorolac tromethamine ophthalmic solution is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction.",
"Description": "Ketorolac tromethamine ophthalmic solution, 0.5% is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for ophthalmic use. Its chemical name is (±)-5-benzoyl-2, 3-dihydro-1H pyrrolizine-1-carboxylic acid compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1) and it has the following structural formula:. The molecular formula of ketorolac tromethamine ophthalmic solution, 0.5% is. C15H13NO3C4H11NO3. Ketorolac tromethamine ophthalmic solution is supplied as a sterile isotonic aqueous 0.5% solution, with a pH of 7.4. Ketorolac tromethamine ophthalmic solution is a racemic mixture of R-(+) and S-(-)- ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. The pKa of ketorolac is 3.5. This white to off-white crystalline substance discolors on prolonged exposure to light. The molecular weight of ketorolac tromethamine is 376.41. The osmolality of ketorolac tromethamine ophthalmic solution is 290 mOsmol/kg. Each mL of ketorolac tromethamine ophthalmic solution, 0.5% contains: Active: Ketorolac Tromethamine 0.5%. Inactives: Edetate Disodium 0.1%; Octoxynol 40; Sodium Chloride; Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust pH (6.8 to 7.4); Water for Injection. Preservative: Benzalkonium Chloride 0.01%."
},
{
"NDCCode": "17478-920-19",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 POUCH (17478-920-19) > 18 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "17478-0920-19",
"ProductNDC": "17478-920",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Balanced Salt",
"NonProprietaryName": "Calcium Chloride, Magnesium Chloride, Potassium Chloride, Sodium Acetate, Sodium Chloride, Sodium Citrate",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20060927",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075503",
"LabelerName": "Akorn",
"SubstanceName": "CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE",
"StrengthNumber": ".48; .3; .75; 3.9; 6.4; 1.7",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2022-05-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20060927",
"SamplePackage": "N"
},
{
"NDCCode": "24385-519-26",
"PackageDescription": "1 BOTTLE in 1 CARTON (24385-519-26) / 118 mL in 1 BOTTLE",
"NDC11Code": "24385-0519-26",
"ProductNDC": "24385-519",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Good Neighbor Pharmacy Cold And Cough",
"NonProprietaryName": "Brompheniramine Maleate, Dextromethorphan Hbr, Phenylephrine Hcl",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20060911",
"EndMarketingDate": "20261130",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Amerisource Bergen",
"SubstanceName": "BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "2; 10; 5",
"StrengthUnit": "mg/10mL; mg/10mL; mg/10mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20060911",
"EndMarketingDatePackage": "20261130",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies. temporarily relieves these symptoms due to hay fever (allergic rhinitis):. runny nose. sneezing. itchy, watery eyes. itching of the nose or throat. temporarily restores freer breathing through the nose."
},
{
"NDCCode": "49574-519-01",
"PackageDescription": "25 kg in 1 DRUM (49574-519-01) ",
"NDC11Code": "49574-0519-01",
"ProductNDC": "49574-519",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Docusate Sodium",
"DosageFormName": "POWDER",
"StartMarketingDate": "20190601",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Hunan Jiudian Pharmaceutical Co.,Ltd.",
"SubstanceName": "DOCUSATE SODIUM",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2025-01-03",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "01-JUN-19"
},
{
"NDCCode": "53943-519-30",
"PackageDescription": "1 BOTTLE in 1 CARTON (53943-519-30) / 30 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "53943-0519-30",
"ProductNDC": "53943-519",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cetirizine Hydrochloride",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078343",
"LabelerName": "Discount Drug Mart, Inc",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200120",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies. : 1 runny nose, 2 sneezing, 3 itchy,watery eyes, 4 itching of the nose or throat ."
},
{
"NDCCode": "53943-519-45",
"PackageDescription": "1 BOTTLE in 1 CARTON (53943-519-45) / 45 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "53943-0519-45",
"ProductNDC": "53943-519",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cetirizine Hydrochloride",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078343",
"LabelerName": "Discount Drug Mart, Inc",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200120",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies. : 1 runny nose, 2 sneezing, 3 itchy,watery eyes, 4 itching of the nose or throat ."
},
{
"NDCCode": "55289-519-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (55289-519-30) ",
"NDC11Code": "55289-0519-30",
"ProductNDC": "55289-519",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperdal",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19931229",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020272",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20110901",
"SamplePackage": "N"
},
{
"NDCCode": "63187-519-06",
"PackageDescription": "6 CAPSULE in 1 BOTTLE, PLASTIC (63187-519-06) ",
"NDC11Code": "63187-0519-06",
"ProductNDC": "63187-519",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vitamin D",
"NonProprietaryName": "Ergocalciferol",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20140516",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090455",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "ERGOCALCIFEROL",
"StrengthNumber": "1.25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Ergocalciferols [CS], Provitamin D2 Compound [EPC]",
"Status": "Active",
"LastUpdate": "2022-04-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171002",
"SamplePackage": "N",
"IndicationAndUsage": "Ergocalciferol Capsules, USP are indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.",
"Description": "Ergocalciferol Capsules, USP are a synthetic calcium regulator for oral administration. Ergocalciferol is a white, colorless crystal, insoluble in water, soluble in organic solvents, and slightly soluble in vegetable oils. It is affected by air and by light. Ergosterol or provitamin D2 is found in plants and yeast and has no antirachitic activity. There are more than 10 substances belonging to a group of steroid compounds, classified as having vitamin D or antirachitic activity. One USP unit of vitamin D2 is equivalent to one International Unit (IU), and 1 mcg of vitamin D2 is equal to 40 USP Units. Each capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units in an edible vegetable oil. Ergocalciferol, also called vitamin D2, is 9,10-secoergosta-5,7,10(19), 22-tetraen-3-ol, (3β,5Z,7E,22E)-; (C28H44O) with a molecular weight of 396.65, and has the following structural formula. Inactive Ingredients: 2-Ethoxyethanol, FD&C Blue #1, FD&C Yellow #5, Gelatin, Glycerin, Lecithin, Medium chain triglyceride, Purified water, Shellac glaze (modified) IN SD-45, Simethicone, Soybean oil and Titanium dioxide."
},
{
"NDCCode": "63187-519-08",
"PackageDescription": "8 CAPSULE in 1 BOTTLE, PLASTIC (63187-519-08) ",
"NDC11Code": "63187-0519-08",
"ProductNDC": "63187-519",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vitamin D",
"NonProprietaryName": "Ergocalciferol",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20140516",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090455",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "ERGOCALCIFEROL",
"StrengthNumber": "1.25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Ergocalciferols [CS], Provitamin D2 Compound [EPC]",
"Status": "Active",
"LastUpdate": "2022-04-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160101",
"SamplePackage": "N",
"IndicationAndUsage": "Ergocalciferol Capsules, USP are indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.",
"Description": "Ergocalciferol Capsules, USP are a synthetic calcium regulator for oral administration. Ergocalciferol is a white, colorless crystal, insoluble in water, soluble in organic solvents, and slightly soluble in vegetable oils. It is affected by air and by light. Ergosterol or provitamin D2 is found in plants and yeast and has no antirachitic activity. There are more than 10 substances belonging to a group of steroid compounds, classified as having vitamin D or antirachitic activity. One USP unit of vitamin D2 is equivalent to one International Unit (IU), and 1 mcg of vitamin D2 is equal to 40 USP Units. Each capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units in an edible vegetable oil. Ergocalciferol, also called vitamin D2, is 9,10-secoergosta-5,7,10(19), 22-tetraen-3-ol, (3β,5Z,7E,22E)-; (C28H44O) with a molecular weight of 396.65, and has the following structural formula. Inactive Ingredients: 2-Ethoxyethanol, FD&C Blue #1, FD&C Yellow #5, Gelatin, Glycerin, Lecithin, Medium chain triglyceride, Purified water, Shellac glaze (modified) IN SD-45, Simethicone, Soybean oil and Titanium dioxide."
},
{
"NDCCode": "63187-519-12",
"PackageDescription": "12 CAPSULE in 1 BOTTLE, PLASTIC (63187-519-12) ",
"NDC11Code": "63187-0519-12",
"ProductNDC": "63187-519",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vitamin D",
"NonProprietaryName": "Ergocalciferol",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20140516",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090455",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "ERGOCALCIFEROL",
"StrengthNumber": "1.25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Ergocalciferols [CS], Provitamin D2 Compound [EPC]",
"Status": "Active",
"LastUpdate": "2022-04-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201028",
"SamplePackage": "N",
"IndicationAndUsage": "Ergocalciferol Capsules, USP are indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.",
"Description": "Ergocalciferol Capsules, USP are a synthetic calcium regulator for oral administration. Ergocalciferol is a white, colorless crystal, insoluble in water, soluble in organic solvents, and slightly soluble in vegetable oils. It is affected by air and by light. Ergosterol or provitamin D2 is found in plants and yeast and has no antirachitic activity. There are more than 10 substances belonging to a group of steroid compounds, classified as having vitamin D or antirachitic activity. One USP unit of vitamin D2 is equivalent to one International Unit (IU), and 1 mcg of vitamin D2 is equal to 40 USP Units. Each capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units in an edible vegetable oil. Ergocalciferol, also called vitamin D2, is 9,10-secoergosta-5,7,10(19), 22-tetraen-3-ol, (3β,5Z,7E,22E)-; (C28H44O) with a molecular weight of 396.65, and has the following structural formula. Inactive Ingredients: 2-Ethoxyethanol, FD&C Blue #1, FD&C Yellow #5, Gelatin, Glycerin, Lecithin, Medium chain triglyceride, Purified water, Shellac glaze (modified) IN SD-45, Simethicone, Soybean oil and Titanium dioxide."
},
{
"NDCCode": "63187-519-16",
"PackageDescription": "16 CAPSULE in 1 BOTTLE, PLASTIC (63187-519-16) ",
"NDC11Code": "63187-0519-16",
"ProductNDC": "63187-519",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vitamin D",
"NonProprietaryName": "Ergocalciferol",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20140516",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090455",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "ERGOCALCIFEROL",
"StrengthNumber": "1.25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Ergocalciferols [CS], Provitamin D2 Compound [EPC]",
"Status": "Active",
"LastUpdate": "2022-04-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160201",
"SamplePackage": "N",
"IndicationAndUsage": "Ergocalciferol Capsules, USP are indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.",
"Description": "Ergocalciferol Capsules, USP are a synthetic calcium regulator for oral administration. Ergocalciferol is a white, colorless crystal, insoluble in water, soluble in organic solvents, and slightly soluble in vegetable oils. It is affected by air and by light. Ergosterol or provitamin D2 is found in plants and yeast and has no antirachitic activity. There are more than 10 substances belonging to a group of steroid compounds, classified as having vitamin D or antirachitic activity. One USP unit of vitamin D2 is equivalent to one International Unit (IU), and 1 mcg of vitamin D2 is equal to 40 USP Units. Each capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units in an edible vegetable oil. Ergocalciferol, also called vitamin D2, is 9,10-secoergosta-5,7,10(19), 22-tetraen-3-ol, (3β,5Z,7E,22E)-; (C28H44O) with a molecular weight of 396.65, and has the following structural formula. Inactive Ingredients: 2-Ethoxyethanol, FD&C Blue #1, FD&C Yellow #5, Gelatin, Glycerin, Lecithin, Medium chain triglyceride, Purified water, Shellac glaze (modified) IN SD-45, Simethicone, Soybean oil and Titanium dioxide."
},
{
"NDCCode": "63187-519-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (63187-519-30) ",
"NDC11Code": "63187-0519-30",
"ProductNDC": "63187-519",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vitamin D",
"NonProprietaryName": "Ergocalciferol",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20140516",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090455",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "ERGOCALCIFEROL",
"StrengthNumber": "1.25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Ergocalciferols [CS], Provitamin D2 Compound [EPC]",
"Status": "Active",
"LastUpdate": "2022-04-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150803",
"SamplePackage": "N",
"IndicationAndUsage": "Ergocalciferol Capsules, USP are indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.",
"Description": "Ergocalciferol Capsules, USP are a synthetic calcium regulator for oral administration. Ergocalciferol is a white, colorless crystal, insoluble in water, soluble in organic solvents, and slightly soluble in vegetable oils. It is affected by air and by light. Ergosterol or provitamin D2 is found in plants and yeast and has no antirachitic activity. There are more than 10 substances belonging to a group of steroid compounds, classified as having vitamin D or antirachitic activity. One USP unit of vitamin D2 is equivalent to one International Unit (IU), and 1 mcg of vitamin D2 is equal to 40 USP Units. Each capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units in an edible vegetable oil. Ergocalciferol, also called vitamin D2, is 9,10-secoergosta-5,7,10(19), 22-tetraen-3-ol, (3β,5Z,7E,22E)-; (C28H44O) with a molecular weight of 396.65, and has the following structural formula. Inactive Ingredients: 2-Ethoxyethanol, FD&C Blue #1, FD&C Yellow #5, Gelatin, Glycerin, Lecithin, Medium chain triglyceride, Purified water, Shellac glaze (modified) IN SD-45, Simethicone, Soybean oil and Titanium dioxide."
},
{
"NDCCode": "63187-519-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE, PLASTIC (63187-519-60) ",
"NDC11Code": "63187-0519-60",
"ProductNDC": "63187-519",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vitamin D",
"NonProprietaryName": "Ergocalciferol",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20140516",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090455",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "ERGOCALCIFEROL",
"StrengthNumber": "1.25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Ergocalciferols [CS], Provitamin D2 Compound [EPC]",
"Status": "Active",
"LastUpdate": "2022-04-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150803",
"SamplePackage": "N",
"IndicationAndUsage": "Ergocalciferol Capsules, USP are indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.",
"Description": "Ergocalciferol Capsules, USP are a synthetic calcium regulator for oral administration. Ergocalciferol is a white, colorless crystal, insoluble in water, soluble in organic solvents, and slightly soluble in vegetable oils. It is affected by air and by light. Ergosterol or provitamin D2 is found in plants and yeast and has no antirachitic activity. There are more than 10 substances belonging to a group of steroid compounds, classified as having vitamin D or antirachitic activity. One USP unit of vitamin D2 is equivalent to one International Unit (IU), and 1 mcg of vitamin D2 is equal to 40 USP Units. Each capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units in an edible vegetable oil. Ergocalciferol, also called vitamin D2, is 9,10-secoergosta-5,7,10(19), 22-tetraen-3-ol, (3β,5Z,7E,22E)-; (C28H44O) with a molecular weight of 396.65, and has the following structural formula. Inactive Ingredients: 2-Ethoxyethanol, FD&C Blue #1, FD&C Yellow #5, Gelatin, Glycerin, Lecithin, Medium chain triglyceride, Purified water, Shellac glaze (modified) IN SD-45, Simethicone, Soybean oil and Titanium dioxide."
},
{
"NDCCode": "63187-519-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE, PLASTIC (63187-519-90) ",
"NDC11Code": "63187-0519-90",
"ProductNDC": "63187-519",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vitamin D",
"NonProprietaryName": "Ergocalciferol",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20140516",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090455",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "ERGOCALCIFEROL",
"StrengthNumber": "1.25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Ergocalciferols [CS], Provitamin D2 Compound [EPC]",
"Status": "Active",
"LastUpdate": "2022-04-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150803",
"SamplePackage": "N",
"IndicationAndUsage": "Ergocalciferol Capsules, USP are indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.",
"Description": "Ergocalciferol Capsules, USP are a synthetic calcium regulator for oral administration. Ergocalciferol is a white, colorless crystal, insoluble in water, soluble in organic solvents, and slightly soluble in vegetable oils. It is affected by air and by light. Ergosterol or provitamin D2 is found in plants and yeast and has no antirachitic activity. There are more than 10 substances belonging to a group of steroid compounds, classified as having vitamin D or antirachitic activity. One USP unit of vitamin D2 is equivalent to one International Unit (IU), and 1 mcg of vitamin D2 is equal to 40 USP Units. Each capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units in an edible vegetable oil. Ergocalciferol, also called vitamin D2, is 9,10-secoergosta-5,7,10(19), 22-tetraen-3-ol, (3β,5Z,7E,22E)-; (C28H44O) with a molecular weight of 396.65, and has the following structural formula. Inactive Ingredients: 2-Ethoxyethanol, FD&C Blue #1, FD&C Yellow #5, Gelatin, Glycerin, Lecithin, Medium chain triglyceride, Purified water, Shellac glaze (modified) IN SD-45, Simethicone, Soybean oil and Titanium dioxide."
},
{
"NDCCode": "65162-519-03",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (65162-519-03) ",
"NDC11Code": "65162-0519-03",
"ProductNDC": "65162-519",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Calcitriol",
"NonProprietaryName": "Calcitriol",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170618",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203289",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "CALCITRIOL",
"StrengthNumber": ".25",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Cholecalciferol [CS], Vitamin D3 Analog [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170618",
"SamplePackage": "N",
"IndicationAndUsage": "Predialysis Patients. Calcitriol capsules re indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 to 55 mL/min) not yet on dialysis. In children, the creatinine clearance value must be corrected for a surface area of 1.73 square meters. A serum iPTH level of ≥100 pg/mL is strongly suggestive of secondary hyperparathyroidism. Dialysis Patients. Calcitriol capsules are indicated in the management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis. In these patients, calcitriol capsules administration enhances calcium absorption, reduces serum alkaline phosphatase levels, and may reduce elevated parathyroid hormone levels and the histological manifestations of osteitis fibrosa cystica and defective mineralization. Hypoparathyroidism Patients. Calcitriol capsules are also indicated in the management of hypocalcemia and its clinical manifestations in patients with postsurgical hypoparathyroidism, idiopathic hypoparathyroidism, and pseudohypoparathyroidism.",
"Description": "Calcitriol is a synthetic vitamin D analog which is active in the regulation of the absorption of calcium from the gastrointestinal tract and its utilization in the body. Calcitriol capsules are available as containing either 0.25 mcg or 0.5 mcg calcitriol, USP. Calcitriol capsules contain butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT) as antioxidants. The capsules also contain medium chain triglycerides. Gelatin capsule shells contain FD&C Yellow No. 6, gelatin, glycerin, methyl paraben sodium, propyl paraben sodium, purified water, and titanium dioxide. The 0.5 mcg capsules also contain FD&C Red No. 40. Calcitriol, USP is a white, crystalline compound which occurs naturally in humans. It has a calculated molecular weight of 416.65 and is soluble in organic solvents but relatively insoluble in water. Chemically, calcitriol, USP is 9,10- seco(5Z,7E)-5,7,10(19)-cholestatriene-1α, 3β, 25-triol and has the following structural formula. The other names frequently used for calcitriol, USP are 1α,25-dihydroxycholecalciferol, 1,25-dihydroxyvitamin D3, 1,25-DHCC, 1,25(OH)2D3 and 1,25-diOHC."
},
{
"NDCCode": "65162-519-10",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (65162-519-10) ",
"NDC11Code": "65162-0519-10",
"ProductNDC": "65162-519",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Calcitriol",
"NonProprietaryName": "Calcitriol",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170618",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203289",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "CALCITRIOL",
"StrengthNumber": ".25",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Cholecalciferol [CS], Vitamin D3 Analog [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170618",
"SamplePackage": "N",
"IndicationAndUsage": "Predialysis Patients. Calcitriol capsules re indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 to 55 mL/min) not yet on dialysis. In children, the creatinine clearance value must be corrected for a surface area of 1.73 square meters. A serum iPTH level of ≥100 pg/mL is strongly suggestive of secondary hyperparathyroidism. Dialysis Patients. Calcitriol capsules are indicated in the management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis. In these patients, calcitriol capsules administration enhances calcium absorption, reduces serum alkaline phosphatase levels, and may reduce elevated parathyroid hormone levels and the histological manifestations of osteitis fibrosa cystica and defective mineralization. Hypoparathyroidism Patients. Calcitriol capsules are also indicated in the management of hypocalcemia and its clinical manifestations in patients with postsurgical hypoparathyroidism, idiopathic hypoparathyroidism, and pseudohypoparathyroidism.",
"Description": "Calcitriol is a synthetic vitamin D analog which is active in the regulation of the absorption of calcium from the gastrointestinal tract and its utilization in the body. Calcitriol capsules are available as containing either 0.25 mcg or 0.5 mcg calcitriol, USP. Calcitriol capsules contain butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT) as antioxidants. The capsules also contain medium chain triglycerides. Gelatin capsule shells contain FD&C Yellow No. 6, gelatin, glycerin, methyl paraben sodium, propyl paraben sodium, purified water, and titanium dioxide. The 0.5 mcg capsules also contain FD&C Red No. 40. Calcitriol, USP is a white, crystalline compound which occurs naturally in humans. It has a calculated molecular weight of 416.65 and is soluble in organic solvents but relatively insoluble in water. Chemically, calcitriol, USP is 9,10- seco(5Z,7E)-5,7,10(19)-cholestatriene-1α, 3β, 25-triol and has the following structural formula. The other names frequently used for calcitriol, USP are 1α,25-dihydroxycholecalciferol, 1,25-dihydroxyvitamin D3, 1,25-DHCC, 1,25(OH)2D3 and 1,25-diOHC."
},
{
"NDCCode": "65162-519-25",
"PackageDescription": "250 CAPSULE in 1 BOTTLE (65162-519-25) ",
"NDC11Code": "65162-0519-25",
"ProductNDC": "65162-519",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Calcitriol",
"NonProprietaryName": "Calcitriol",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170618",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203289",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "CALCITRIOL",
"StrengthNumber": ".25",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Cholecalciferol [CS], Vitamin D3 Analog [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170618",
"SamplePackage": "N",
"IndicationAndUsage": "Predialysis Patients. Calcitriol capsules re indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 to 55 mL/min) not yet on dialysis. In children, the creatinine clearance value must be corrected for a surface area of 1.73 square meters. A serum iPTH level of ≥100 pg/mL is strongly suggestive of secondary hyperparathyroidism. Dialysis Patients. Calcitriol capsules are indicated in the management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis. In these patients, calcitriol capsules administration enhances calcium absorption, reduces serum alkaline phosphatase levels, and may reduce elevated parathyroid hormone levels and the histological manifestations of osteitis fibrosa cystica and defective mineralization. Hypoparathyroidism Patients. Calcitriol capsules are also indicated in the management of hypocalcemia and its clinical manifestations in patients with postsurgical hypoparathyroidism, idiopathic hypoparathyroidism, and pseudohypoparathyroidism.",
"Description": "Calcitriol is a synthetic vitamin D analog which is active in the regulation of the absorption of calcium from the gastrointestinal tract and its utilization in the body. Calcitriol capsules are available as containing either 0.25 mcg or 0.5 mcg calcitriol, USP. Calcitriol capsules contain butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT) as antioxidants. The capsules also contain medium chain triglycerides. Gelatin capsule shells contain FD&C Yellow No. 6, gelatin, glycerin, methyl paraben sodium, propyl paraben sodium, purified water, and titanium dioxide. The 0.5 mcg capsules also contain FD&C Red No. 40. Calcitriol, USP is a white, crystalline compound which occurs naturally in humans. It has a calculated molecular weight of 416.65 and is soluble in organic solvents but relatively insoluble in water. Chemically, calcitriol, USP is 9,10- seco(5Z,7E)-5,7,10(19)-cholestatriene-1α, 3β, 25-triol and has the following structural formula. The other names frequently used for calcitriol, USP are 1α,25-dihydroxycholecalciferol, 1,25-dihydroxyvitamin D3, 1,25-DHCC, 1,25(OH)2D3 and 1,25-diOHC."
},
{
"NDCCode": "69423-519-73",
"PackageDescription": "1 CANISTER in 1 CARTON (69423-519-73) > 73 g in 1 CANISTER",
"NDC11Code": "69423-0519-73",
"ProductNDC": "69423-519",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Old Spice Sweat Defense Knockout Soft",
"NonProprietaryName": "Aluminum Zirconium Trichlorohydrex Gly",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201222",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part350",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"SubstanceName": "ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY",
"StrengthNumber": "19",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20201222",
"SamplePackage": "N",
"IndicationAndUsage": "reduces underarm wetness."
},
{
"NDCCode": "84515-519-01",
"PackageDescription": "50 g in 1 BOX (84515-519-01) ",
"NDC11Code": "84515-0519-01",
"ProductNDC": "84515-519",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Retinol Collagen",
"NonProprietaryName": "Retinol Collagen",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241017",
"EndMarketingDate": "20311231",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Yiwu Xinqian E Commerce Co Ltd",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20241017",
"EndMarketingDatePackage": "20311231",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "84682-519-01",
"PackageDescription": "50 mL in 1 BOX (84682-519-01) ",
"NDC11Code": "84682-0519-01",
"ProductNDC": "84682-519",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Trstay Hair Growth Oil",
"NonProprietaryName": "Trstay Hair Growth Oil",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241022",
"EndMarketingDate": "20311031",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M032",
"LabelerName": "Yiwu Yucheng E Commerce Co Ltd",
"SubstanceName": "MINOXIDIL",
"StrengthNumber": "5",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20241022",
"EndMarketingDatePackage": "20311031",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "17478-151-42",
"PackageDescription": "1 VIAL in 1 BOX, UNIT-DOSE (17478-151-42) > 10 mL in 1 VIAL",
"NDC11Code": "17478-0151-42",
"ProductNDC": "17478-151",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rifampin",
"NonProprietaryName": "Rifampin",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20120601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065502",
"LabelerName": "Akorn",
"SubstanceName": "RIFAMPIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Rifamycin Antibacterial [EPC], Rifamycins [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20120601",
"SamplePackage": "N",
"IndicationAndUsage": "In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.",
"Description": "Rifampin for injection USP contains rifampin 600 mg, sodium formaldehyde sulfoxylate dihydrate 10 mg, and sodium hydroxide to adjust pH. Rifampin for injection is a sterile, lyophilized powder for intravenous infusion only. Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either:. 3-[[(4-Methyl-1-piperazinyl)imino]methyl]rifamycin. or. 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,20,22–heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7- (epoxypentadeca[1,11,13]trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is."
},
{
"NDCCode": "17478-831-01",
"PackageDescription": "10 AMPULE in 1 CARTON (17478-831-01) > 1 mL in 1 AMPULE",
"NDC11Code": "17478-0831-01",
"ProductNDC": "17478-831",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Calcitriol",
"NonProprietaryName": "Calcitriol",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20130322",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078066",
"LabelerName": "Akorn",
"SubstanceName": "CALCITRIOL",
"StrengthNumber": "1",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Cholecalciferol [CS], Vitamin D3 Analog [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20130322",
"SamplePackage": "N",
"IndicationAndUsage": "Calcitriol injection is indicated in the management of hypocalcemia in patients undergoing chronic renal dialysis. It has been shown to significantly reduce elevated parathyroid hormone levels. Reduction of PTH has been shown to result in an improvement in renal osteodystrophy.",
"Description": "Calcitriol Injection is synthetically manufactured calcitriol and is available as a sterile, isotonic, clear, colorless to yellow, aqueous solution for intravenous injection. Calcitriol Injection, USP is available in 1 mL ampules. Each 1 mL contains: Active: Calcitriol, 1 mcg. Inactives: Dibasic Sodium Phosphate, Anhydrous 7.6 mg; Edetate Disodium, Dihydrate 1.1 mg; Monobasic Sodium Phosphate, Monohydrate 1.8 mg; Polysorbate 20, 4 mg; Sodium Ascorbate 10 mg; Sodium Chloride 1.5 mg; pH Range is from 6.5 to 8.0 and Water for Injection. Calcitriol is a colorless, crystalline compound which occurs naturally in humans. It is soluble in organic solvents but relatively insoluble in water. Calcitriol is chemically designated (5Z, 7E)-9,10 secocholesta 5,7,10(19)-triene-1α, 3β, 25-triol and has the following structural formula:. The other names frequently used for calcitriol are 1α,25-dihydroxycholecalciferol,1α, 25-dihydroxyvitamin D3,1,25-DHCC,1,25(OH)2D3 and 1,25-diOHC."
},
{
"NDCCode": "17478-931-01",
"PackageDescription": "10 AMPULE in 1 CARTON (17478-931-01) > 1 mL in 1 AMPULE",
"NDC11Code": "17478-0931-01",
"ProductNDC": "17478-931",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Calcitriol",
"NonProprietaryName": "Calcitriol",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20111014",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078066",
"LabelerName": "Akorn",
"SubstanceName": "CALCITRIOL",
"StrengthNumber": "1",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Cholecalciferol [CS], Vitamin D3 Analog [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20111014",
"SamplePackage": "N",
"IndicationAndUsage": "Calcitriol injection is indicated in the management of hypocalcemia in patients undergoing chronic renal dialysis. It has been shown to significantly reduce elevated parathyroid hormone levels. Reduction of PTH has been shown to result in an improvement in renal osteodystrophy.",
"Description": "Calcitriol injection is synthetically manufactured calcitriol and is available as a sterile, isotonic, clear, colorless to yellow, aqueous solution for intravenous injection. Calcitriol Injection, USP is available in 1 mL ampules. Each 1 mL contains: Active: Calcitriol, 1 or 2 mcg. Inactives: Dibasic Sodium Phosphate, Anhydrous 7.6 mg; Edetate Disodium, Dihydrate 1.1 mg; Monobasic Sodium Phosphate, Monohydrate 1.8 mg; Polysorbate 20, 4 mg; Sodium Ascorbate 10 mg; Sodium Chloride 1.5 mg; pH Range is from 6.5 to 8.0 and Water for Injection. Calcitriol is a colorless, crystalline compound which occurs naturally in humans. It is soluble in organic solvents but relatively insoluble in water. Calcitriol is chemically designated (5Z,7E)-9,10 secocholesta-5,7,10(19)-triene-1α, 3β, 25-triol and has the following structural formula:. The other names frequently used for calcitriol are 1α,25-dihydroxycholecalciferol,1α,25-dihydroxyvitamin D3 ,1,25-DHCC,1,25(OH)2D3 and 1,25-diOHC."
},
{
"NDCCode": "17478-932-01",
"PackageDescription": "10 AMPULE in 1 CARTON (17478-932-01) > 1 mL in 1 AMPULE",
"NDC11Code": "17478-0932-01",
"ProductNDC": "17478-932",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Calcitriol",
"NonProprietaryName": "Calcitriol",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20111014",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078066",
"LabelerName": "Akorn",
"SubstanceName": "CALCITRIOL",
"StrengthNumber": "2",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Cholecalciferol [CS], Vitamin D3 Analog [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20111014",
"SamplePackage": "N",
"IndicationAndUsage": "Calcitriol injection is indicated in the management of hypocalcemia in patients undergoing chronic renal dialysis. It has been shown to significantly reduce elevated parathyroid hormone levels. Reduction of PTH has been shown to result in an improvement in renal osteodystrophy.",
"Description": "Calcitriol injection is synthetically manufactured calcitriol and is available as a sterile, isotonic, clear, colorless to yellow, aqueous solution for intravenous injection. Calcitriol Injection, USP is available in 1 mL ampules. Each 1 mL contains: Active: Calcitriol, 1 or 2 mcg. Inactives: Dibasic Sodium Phosphate, Anhydrous 7.6 mg; Edetate Disodium, Dihydrate 1.1 mg; Monobasic Sodium Phosphate, Monohydrate 1.8 mg; Polysorbate 20, 4 mg; Sodium Ascorbate 10 mg; Sodium Chloride 1.5 mg; pH Range is from 6.5 to 8.0 and Water for Injection. Calcitriol is a colorless, crystalline compound which occurs naturally in humans. It is soluble in organic solvents but relatively insoluble in water. Calcitriol is chemically designated (5Z,7E)-9,10 secocholesta-5,7,10(19)-triene-1α, 3β, 25-triol and has the following structural formula:. The other names frequently used for calcitriol are 1α,25-dihydroxycholecalciferol,1α,25-dihydroxyvitamin D3 ,1,25-DHCC,1,25(OH)2D3 and 1,25-diOHC."
},
{
"NDCCode": "0944-2815-01",
"PackageDescription": "1 KIT in 1 CARTON (0944-2815-01) * 50 mL in 1 VIAL (0944-2804-04) * 50 mL in 1 VIAL, GLASS (64764-519-50) ",
"NDC11Code": "00944-2815-01",
"ProductNDC": "0944-2815",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Aralast",
"ProprietaryNameSuffix": "Np",
"NonProprietaryName": "Alpha-1-proteinase Inhibitor (human)",
"DosageFormName": "KIT",
"StartMarketingDate": "20021223",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125039",
"LabelerName": "Takeda Pharmaceuticals America, Inc.",
"Status": "Active",
"LastUpdate": "2025-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20021223",
"SamplePackage": "N",
"IndicationAndUsage": "ARALAST NP is an Alpha1-Proteinase Inhibitor (Alpha1-PI) indicated for chronic augmentation therapy in adults with clinically evident emphysema due to severe congenital deficiency of Alpha1-PI (alpha1-antitrypsin deficiency). ARALAST NP increases antigenic and functional (anti-neutrophil elastase capacity, ANEC) serum levels and antigenic lung epithelial lining fluid levels of Alpha1-PI. The effect of augmentation therapy with any Alpha1-PI, including ARALAST NP, on pulmonary exacerbations and on the progression of emphysema in alpha1-antitrypsin deficiency has not been conclusively demonstrated in randomized, controlled clinical trials. Clinical data demonstrating the long-term effects of chronic augmentation and maintenance therapy with ARALAST NP or ARALAST are not available. ARALAST NP is not indicated as therapy for lung disease in patients in whom severe congenital Alpha1-PI deficiency has not been established.",
"Description": "ARALAST NP contains approximately 2% Alpha1-PI with truncated C-terminal lysine (removal of Lys394), whereas ARALAST contains approximately 67% Alpha1-PI with the C-terminal lysine truncation.8 No known data suggest influence of these structural modifications on the functional activity and immunogenicity of Alpha1-PI.9. ARALAST NP is a sterile, lyophilized preparation of purified human alpha1-proteinase inhibitor (Alpha1-PI), also known as alpha1-antitrypsin (AAT).1 ARALAST NP is a similar product to ARALAST, containing the same active components of plasma Alpha1-PI with identical formulations. ARALAST NP is prepared from large pools of human plasma by using the cold ethanol fractionation process, followed by purification steps including polyethylene glycol and zinc chloride precipitations and ion exchange chromatography. To reduce the risk of viral transmission, the manufacturing process includes treatment with a solvent detergent (S/D) mixture [tri-n-butyl phosphate and polysorbate 80] to inactivate enveloped viral agents such as human immunodeficiency virus (HIV), hepatitis B (HBV), and hepatitis C (HCV). In addition, a nanofiltration step is incorporated into the manufacturing process to reduce the risk of transmission of enveloped and non-enveloped viral agents. Based on in vitro studies, the process used to produce ARALAST NP has been shown to inactivate and/or partition various viruses as shown in Table 3 below. The unreconstituted, lyophilized cake should be white or off-white to slightly yellow-green or yellow in color. When reconstituted as directed, the concentration of functionally active Alpha1-PI is 16.0 – 26.0 mg/mL and the specific activity is ≥0.55 mg active Alpha1-PI/mg total protein. The composition of the reconstituted product is as follows. Each vial of ARALAST NP has the functional activity, as determined by inhibition of porcine pancreatic elastase, stated on the label. The formulation contains no preservative. The pH of the solution ranges from 7.2 to 7.8. Product must only be administered intravenously."
},
{
"NDCCode": "10812-519-01",
"PackageDescription": "1 APPLICATOR in 1 BLISTER PACK (10812-519-01) / 1.4 g in 1 APPLICATOR",
"NDC11Code": "10812-0519-01",
"ProductNDC": "10812-519",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neutrogena",
"ProprietaryNameSuffix": "Skin Clearing Blemish Concealer - Fair 05",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100205",
"EndMarketingDate": "20250831",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M006",
"LabelerName": "Johnson & Johnson Consumer Inc.",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "5.5",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2025-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20100205",
"EndMarketingDatePackage": "20250831",
"SamplePackage": "N",
"IndicationAndUsage": "For the treatment of acne."
},
{
"NDCCode": "11344-519-18",
"PackageDescription": "70 g in 1 JAR (11344-519-18) ",
"NDC11Code": "11344-0519-18",
"ProductNDC": "11344-519",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Petroleum",
"NonProprietaryName": "White Petrolatum",
"DosageFormName": "JELLY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090512",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "Vi-Jon, LLC",
"SubstanceName": "PETROLATUM",
"StrengthNumber": "100",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2022-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20090512",
"SamplePackage": "N"
},
{
"NDCCode": "11344-519-27",
"PackageDescription": "368 g in 1 JAR (11344-519-27) ",
"NDC11Code": "11344-0519-27",
"ProductNDC": "11344-519",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Petroleum",
"NonProprietaryName": "White Petrolatum",
"DosageFormName": "JELLY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090512",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "Vi-Jon, LLC",
"SubstanceName": "PETROLATUM",
"StrengthNumber": "100",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2022-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20090512",
"SamplePackage": "N"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>17478-519-19</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (17478-519-19) > 3 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>17478-0519-19</NDC11Code>
<ProductNDC>17478-519</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Moxifloxacin</ProprietaryName>
<NonProprietaryName>Moxifloxacin</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20171109</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202916</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>MOXIFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC], Quinolones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171109</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Moxifloxacin Ophthalmic Solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:. Corynebacterium species*. Micrococcus luteus*. Staphylococcus aureus. Staphylococcus epidermidis. Staphylococcus haemolyticus. Staphylococcus hominis. Staphylococcus warneri*. Streptococcus pneumoniae. Streptococcus viridans group. Acinetobacter lwoffii*. Haemophilus influenzae. Haemophilus parainfluenzae*. Chlamydia trachomatis. *Efficacy for this organism was studied in fewer than 10 infections.</IndicationAndUsage>
<Description>Moxifloxacin Ophthalmic Solution, USP 0.5% is a sterile solution for topical ophthalmic use. Moxifloxacin hydrochloride is an 8-methoxy fluoroquinolone anti-infective, with a diazabicyclononyl ring at the C7 position. The chemical name for moxifloxacin hydrochloride 1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-[(4aS,7aS)-octahydro-6H-pyrrolol[3,4-b] pyridin-6-yl]-4-oxo-3-quinolinecarboxylic acid, monohydrochloride. The molecular formula for moxifloxacin hydrochloride is C12H24FN3O4HCl and its molecular weight is 437.9 g/mol. The chemical structure is presented below:. Moxifloxacin hydrochloride is a slightly yellow to yellow crystalline powder. Each mL of Moxifloxacin Ophthalmic Solution, USP contains 5.45 mg moxifloxacin hydrochloride, equivalent to 5 mg moxifloxacin base. Moxifloxacin Ophthalmic Solution contains Active: Moxifloxacin 0.5% (5 mg/mL); Inactives: Boric acid, sodium chloride, and water for injection. May also contain hydrochloric acid/sodium hydroxide to adjust pH to approximately 6.8. Moxifloxacin Ophthalmic Solution, USP is an isotonic solution with an osmolality of approximately 290 mOsm/kg.</Description>
</NDC>
<NDC>
<NDCCode>63940-519-19</NDCCode>
<PackageDescription>1 BOTTLE in 1 PACKAGE (63940-519-19) > 8 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>63940-0519-19</NDC11Code>
<ProductNDC>63940-519</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pain Reliever</ProprietaryName>
<ProprietaryNameSuffix>Extra Strength</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040510</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>Harmon Store Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-05-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040510</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>17478-209-19</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (17478-209-19) > 3 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>17478-0209-19</NDC11Code>
<ProductNDC>17478-209</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketorolac Tromethamine</ProprietaryName>
<NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20091105</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078434</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>KETOROLAC TROMETHAMINE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ketorolac tromethamine ophthalmic solution is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. Ketorolac tromethamine ophthalmic solution is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction.</IndicationAndUsage>
<Description>Ketorolac tromethamine ophthalmic solution, 0.5% is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for ophthalmic use. Its chemical name is (±)-5-benzoyl-2, 3-dihydro-1H pyrrolizine-1-carboxylic acid compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1) and it has the following structural formula:. The molecular formula of ketorolac tromethamine ophthalmic solution, 0.5% is. C15H13NO3C4H11NO3. Ketorolac tromethamine ophthalmic solution is supplied as a sterile isotonic aqueous 0.5% solution, with a pH of 7.4. Ketorolac tromethamine ophthalmic solution is a racemic mixture of R-(+) and S-(-)- ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. The pKa of ketorolac is 3.5. This white to off-white crystalline substance discolors on prolonged exposure to light. The molecular weight of ketorolac tromethamine is 376.41. The osmolality of ketorolac tromethamine ophthalmic solution is 290 mOsmol/kg. Each mL of ketorolac tromethamine ophthalmic solution, 0.5% contains: Active: Ketorolac Tromethamine 0.5%. Inactives: Edetate Disodium 0.1%; Octoxynol 40; Sodium Chloride; Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust pH (6.8 to 7.4); Water for Injection. Preservative: Benzalkonium Chloride 0.01%.</Description>
</NDC>
<NDC>
<NDCCode>17478-920-19</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 POUCH (17478-920-19) > 18 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>17478-0920-19</NDC11Code>
<ProductNDC>17478-920</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Balanced Salt</ProprietaryName>
<NonProprietaryName>Calcium Chloride, Magnesium Chloride, Potassium Chloride, Sodium Acetate, Sodium Chloride, Sodium Citrate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20060927</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075503</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE</SubstanceName>
<StrengthNumber>.48; .3; .75; 3.9; 6.4; 1.7</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-05-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060927</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>24385-519-26</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (24385-519-26) / 118 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>24385-0519-26</NDC11Code>
<ProductNDC>24385-519</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Good Neighbor Pharmacy Cold And Cough</ProprietaryName>
<NonProprietaryName>Brompheniramine Maleate, Dextromethorphan Hbr, Phenylephrine Hcl</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060911</StartMarketingDate>
<EndMarketingDate>20261130</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Amerisource Bergen</LabelerName>
<SubstanceName>BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2; 10; 5</StrengthNumber>
<StrengthUnit>mg/10mL; mg/10mL; mg/10mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20060911</StartMarketingDatePackage>
<EndMarketingDatePackage>20261130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies. temporarily relieves these symptoms due to hay fever (allergic rhinitis):. runny nose. sneezing. itchy, watery eyes. itching of the nose or throat. temporarily restores freer breathing through the nose.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49574-519-01</NDCCode>
<PackageDescription>25 kg in 1 DRUM (49574-519-01) </PackageDescription>
<NDC11Code>49574-0519-01</NDC11Code>
<ProductNDC>49574-519</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Docusate Sodium</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20190601</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Hunan Jiudian Pharmaceutical Co.,Ltd.</LabelerName>
<SubstanceName>DOCUSATE SODIUM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-01-03</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-JUN-19</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>53943-519-30</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (53943-519-30) / 30 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>53943-0519-30</NDC11Code>
<ProductNDC>53943-519</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cetirizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078343</ApplicationNumber>
<LabelerName>Discount Drug Mart, Inc</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies. : 1 runny nose, 2 sneezing, 3 itchy,watery eyes, 4 itching of the nose or throat .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>53943-519-45</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (53943-519-45) / 45 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>53943-0519-45</NDC11Code>
<ProductNDC>53943-519</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cetirizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078343</ApplicationNumber>
<LabelerName>Discount Drug Mart, Inc</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies. : 1 runny nose, 2 sneezing, 3 itchy,watery eyes, 4 itching of the nose or throat .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55289-519-30</NDCCode>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperdal</ProprietaryName>
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<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
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<PackageDescription>6 CAPSULE in 1 BOTTLE, PLASTIC (63187-519-06) </PackageDescription>
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<ProductNDC>63187-519</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vitamin D</ProprietaryName>
<NonProprietaryName>Ergocalciferol</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140516</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090455</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>ERGOCALCIFEROL</SubstanceName>
<StrengthNumber>1.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Ergocalciferols [CS], Provitamin D2 Compound [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-04-22</LastUpdate>
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<IndicationAndUsage>Ergocalciferol Capsules, USP are indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.</IndicationAndUsage>
<Description>Ergocalciferol Capsules, USP are a synthetic calcium regulator for oral administration. Ergocalciferol is a white, colorless crystal, insoluble in water, soluble in organic solvents, and slightly soluble in vegetable oils. It is affected by air and by light. Ergosterol or provitamin D2 is found in plants and yeast and has no antirachitic activity. There are more than 10 substances belonging to a group of steroid compounds, classified as having vitamin D or antirachitic activity. One USP unit of vitamin D2 is equivalent to one International Unit (IU), and 1 mcg of vitamin D2 is equal to 40 USP Units. Each capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units in an edible vegetable oil. Ergocalciferol, also called vitamin D2, is 9,10-secoergosta-5,7,10(19), 22-tetraen-3-ol, (3β,5Z,7E,22E)-; (C28H44O) with a molecular weight of 396.65, and has the following structural formula. Inactive Ingredients: 2-Ethoxyethanol, FD&C Blue #1, FD&C Yellow #5, Gelatin, Glycerin, Lecithin, Medium chain triglyceride, Purified water, Shellac glaze (modified) IN SD-45, Simethicone, Soybean oil and Titanium dioxide.</Description>
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<NDC>
<NDCCode>63187-519-08</NDCCode>
<PackageDescription>8 CAPSULE in 1 BOTTLE, PLASTIC (63187-519-08) </PackageDescription>
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<ProductNDC>63187-519</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20140516</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090455</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>ERGOCALCIFEROL</SubstanceName>
<StrengthNumber>1.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Ergocalciferols [CS], Provitamin D2 Compound [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-04-22</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<IndicationAndUsage>Ergocalciferol Capsules, USP are indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.</IndicationAndUsage>
<Description>Ergocalciferol Capsules, USP are a synthetic calcium regulator for oral administration. Ergocalciferol is a white, colorless crystal, insoluble in water, soluble in organic solvents, and slightly soluble in vegetable oils. It is affected by air and by light. Ergosterol or provitamin D2 is found in plants and yeast and has no antirachitic activity. There are more than 10 substances belonging to a group of steroid compounds, classified as having vitamin D or antirachitic activity. One USP unit of vitamin D2 is equivalent to one International Unit (IU), and 1 mcg of vitamin D2 is equal to 40 USP Units. Each capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units in an edible vegetable oil. Ergocalciferol, also called vitamin D2, is 9,10-secoergosta-5,7,10(19), 22-tetraen-3-ol, (3β,5Z,7E,22E)-; (C28H44O) with a molecular weight of 396.65, and has the following structural formula. Inactive Ingredients: 2-Ethoxyethanol, FD&C Blue #1, FD&C Yellow #5, Gelatin, Glycerin, Lecithin, Medium chain triglyceride, Purified water, Shellac glaze (modified) IN SD-45, Simethicone, Soybean oil and Titanium dioxide.</Description>
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<NDC>
<NDCCode>63187-519-12</NDCCode>
<PackageDescription>12 CAPSULE in 1 BOTTLE, PLASTIC (63187-519-12) </PackageDescription>
<NDC11Code>63187-0519-12</NDC11Code>
<ProductNDC>63187-519</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vitamin D</ProprietaryName>
<NonProprietaryName>Ergocalciferol</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140516</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090455</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>ERGOCALCIFEROL</SubstanceName>
<StrengthNumber>1.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Ergocalciferols [CS], Provitamin D2 Compound [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-04-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201028</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ergocalciferol Capsules, USP are indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.</IndicationAndUsage>
<Description>Ergocalciferol Capsules, USP are a synthetic calcium regulator for oral administration. Ergocalciferol is a white, colorless crystal, insoluble in water, soluble in organic solvents, and slightly soluble in vegetable oils. It is affected by air and by light. Ergosterol or provitamin D2 is found in plants and yeast and has no antirachitic activity. There are more than 10 substances belonging to a group of steroid compounds, classified as having vitamin D or antirachitic activity. One USP unit of vitamin D2 is equivalent to one International Unit (IU), and 1 mcg of vitamin D2 is equal to 40 USP Units. Each capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units in an edible vegetable oil. Ergocalciferol, also called vitamin D2, is 9,10-secoergosta-5,7,10(19), 22-tetraen-3-ol, (3β,5Z,7E,22E)-; (C28H44O) with a molecular weight of 396.65, and has the following structural formula. Inactive Ingredients: 2-Ethoxyethanol, FD&C Blue #1, FD&C Yellow #5, Gelatin, Glycerin, Lecithin, Medium chain triglyceride, Purified water, Shellac glaze (modified) IN SD-45, Simethicone, Soybean oil and Titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>63187-519-16</NDCCode>
<PackageDescription>16 CAPSULE in 1 BOTTLE, PLASTIC (63187-519-16) </PackageDescription>
<NDC11Code>63187-0519-16</NDC11Code>
<ProductNDC>63187-519</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vitamin D</ProprietaryName>
<NonProprietaryName>Ergocalciferol</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140516</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090455</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>ERGOCALCIFEROL</SubstanceName>
<StrengthNumber>1.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Ergocalciferols [CS], Provitamin D2 Compound [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-04-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ergocalciferol Capsules, USP are indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.</IndicationAndUsage>
<Description>Ergocalciferol Capsules, USP are a synthetic calcium regulator for oral administration. Ergocalciferol is a white, colorless crystal, insoluble in water, soluble in organic solvents, and slightly soluble in vegetable oils. It is affected by air and by light. Ergosterol or provitamin D2 is found in plants and yeast and has no antirachitic activity. There are more than 10 substances belonging to a group of steroid compounds, classified as having vitamin D or antirachitic activity. One USP unit of vitamin D2 is equivalent to one International Unit (IU), and 1 mcg of vitamin D2 is equal to 40 USP Units. Each capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units in an edible vegetable oil. Ergocalciferol, also called vitamin D2, is 9,10-secoergosta-5,7,10(19), 22-tetraen-3-ol, (3β,5Z,7E,22E)-; (C28H44O) with a molecular weight of 396.65, and has the following structural formula. Inactive Ingredients: 2-Ethoxyethanol, FD&C Blue #1, FD&C Yellow #5, Gelatin, Glycerin, Lecithin, Medium chain triglyceride, Purified water, Shellac glaze (modified) IN SD-45, Simethicone, Soybean oil and Titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>63187-519-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE, PLASTIC (63187-519-30) </PackageDescription>
<NDC11Code>63187-0519-30</NDC11Code>
<ProductNDC>63187-519</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vitamin D</ProprietaryName>
<NonProprietaryName>Ergocalciferol</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140516</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090455</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>ERGOCALCIFEROL</SubstanceName>
<StrengthNumber>1.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Ergocalciferols [CS], Provitamin D2 Compound [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-04-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150803</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ergocalciferol Capsules, USP are indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.</IndicationAndUsage>
<Description>Ergocalciferol Capsules, USP are a synthetic calcium regulator for oral administration. Ergocalciferol is a white, colorless crystal, insoluble in water, soluble in organic solvents, and slightly soluble in vegetable oils. It is affected by air and by light. Ergosterol or provitamin D2 is found in plants and yeast and has no antirachitic activity. There are more than 10 substances belonging to a group of steroid compounds, classified as having vitamin D or antirachitic activity. One USP unit of vitamin D2 is equivalent to one International Unit (IU), and 1 mcg of vitamin D2 is equal to 40 USP Units. Each capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units in an edible vegetable oil. Ergocalciferol, also called vitamin D2, is 9,10-secoergosta-5,7,10(19), 22-tetraen-3-ol, (3β,5Z,7E,22E)-; (C28H44O) with a molecular weight of 396.65, and has the following structural formula. Inactive Ingredients: 2-Ethoxyethanol, FD&C Blue #1, FD&C Yellow #5, Gelatin, Glycerin, Lecithin, Medium chain triglyceride, Purified water, Shellac glaze (modified) IN SD-45, Simethicone, Soybean oil and Titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>63187-519-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE, PLASTIC (63187-519-60) </PackageDescription>
<NDC11Code>63187-0519-60</NDC11Code>
<ProductNDC>63187-519</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vitamin D</ProprietaryName>
<NonProprietaryName>Ergocalciferol</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140516</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090455</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>ERGOCALCIFEROL</SubstanceName>
<StrengthNumber>1.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Ergocalciferols [CS], Provitamin D2 Compound [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-04-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150803</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ergocalciferol Capsules, USP are indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.</IndicationAndUsage>
<Description>Ergocalciferol Capsules, USP are a synthetic calcium regulator for oral administration. Ergocalciferol is a white, colorless crystal, insoluble in water, soluble in organic solvents, and slightly soluble in vegetable oils. It is affected by air and by light. Ergosterol or provitamin D2 is found in plants and yeast and has no antirachitic activity. There are more than 10 substances belonging to a group of steroid compounds, classified as having vitamin D or antirachitic activity. One USP unit of vitamin D2 is equivalent to one International Unit (IU), and 1 mcg of vitamin D2 is equal to 40 USP Units. Each capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units in an edible vegetable oil. Ergocalciferol, also called vitamin D2, is 9,10-secoergosta-5,7,10(19), 22-tetraen-3-ol, (3β,5Z,7E,22E)-; (C28H44O) with a molecular weight of 396.65, and has the following structural formula. Inactive Ingredients: 2-Ethoxyethanol, FD&C Blue #1, FD&C Yellow #5, Gelatin, Glycerin, Lecithin, Medium chain triglyceride, Purified water, Shellac glaze (modified) IN SD-45, Simethicone, Soybean oil and Titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>63187-519-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE, PLASTIC (63187-519-90) </PackageDescription>
<NDC11Code>63187-0519-90</NDC11Code>
<ProductNDC>63187-519</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vitamin D</ProprietaryName>
<NonProprietaryName>Ergocalciferol</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140516</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090455</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>ERGOCALCIFEROL</SubstanceName>
<StrengthNumber>1.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Ergocalciferols [CS], Provitamin D2 Compound [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-04-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150803</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ergocalciferol Capsules, USP are indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.</IndicationAndUsage>
<Description>Ergocalciferol Capsules, USP are a synthetic calcium regulator for oral administration. Ergocalciferol is a white, colorless crystal, insoluble in water, soluble in organic solvents, and slightly soluble in vegetable oils. It is affected by air and by light. Ergosterol or provitamin D2 is found in plants and yeast and has no antirachitic activity. There are more than 10 substances belonging to a group of steroid compounds, classified as having vitamin D or antirachitic activity. One USP unit of vitamin D2 is equivalent to one International Unit (IU), and 1 mcg of vitamin D2 is equal to 40 USP Units. Each capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units in an edible vegetable oil. Ergocalciferol, also called vitamin D2, is 9,10-secoergosta-5,7,10(19), 22-tetraen-3-ol, (3β,5Z,7E,22E)-; (C28H44O) with a molecular weight of 396.65, and has the following structural formula. Inactive Ingredients: 2-Ethoxyethanol, FD&C Blue #1, FD&C Yellow #5, Gelatin, Glycerin, Lecithin, Medium chain triglyceride, Purified water, Shellac glaze (modified) IN SD-45, Simethicone, Soybean oil and Titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>65162-519-03</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (65162-519-03) </PackageDescription>
<NDC11Code>65162-0519-03</NDC11Code>
<ProductNDC>65162-519</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Calcitriol</ProprietaryName>
<NonProprietaryName>Calcitriol</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170618</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203289</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>CALCITRIOL</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Cholecalciferol [CS], Vitamin D3 Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170618</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Predialysis Patients. Calcitriol capsules re indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 to 55 mL/min) not yet on dialysis. In children, the creatinine clearance value must be corrected for a surface area of 1.73 square meters. A serum iPTH level of ≥100 pg/mL is strongly suggestive of secondary hyperparathyroidism. Dialysis Patients. Calcitriol capsules are indicated in the management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis. In these patients, calcitriol capsules administration enhances calcium absorption, reduces serum alkaline phosphatase levels, and may reduce elevated parathyroid hormone levels and the histological manifestations of osteitis fibrosa cystica and defective mineralization. Hypoparathyroidism Patients. Calcitriol capsules are also indicated in the management of hypocalcemia and its clinical manifestations in patients with postsurgical hypoparathyroidism, idiopathic hypoparathyroidism, and pseudohypoparathyroidism.</IndicationAndUsage>
<Description>Calcitriol is a synthetic vitamin D analog which is active in the regulation of the absorption of calcium from the gastrointestinal tract and its utilization in the body. Calcitriol capsules are available as containing either 0.25 mcg or 0.5 mcg calcitriol, USP. Calcitriol capsules contain butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT) as antioxidants. The capsules also contain medium chain triglycerides. Gelatin capsule shells contain FD&C Yellow No. 6, gelatin, glycerin, methyl paraben sodium, propyl paraben sodium, purified water, and titanium dioxide. The 0.5 mcg capsules also contain FD&C Red No. 40. Calcitriol, USP is a white, crystalline compound which occurs naturally in humans. It has a calculated molecular weight of 416.65 and is soluble in organic solvents but relatively insoluble in water. Chemically, calcitriol, USP is 9,10- seco(5Z,7E)-5,7,10(19)-cholestatriene-1α, 3β, 25-triol and has the following structural formula. The other names frequently used for calcitriol, USP are 1α,25-dihydroxycholecalciferol, 1,25-dihydroxyvitamin D3, 1,25-DHCC, 1,25(OH)2D3 and 1,25-diOHC.</Description>
</NDC>
<NDC>
<NDCCode>65162-519-10</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (65162-519-10) </PackageDescription>
<NDC11Code>65162-0519-10</NDC11Code>
<ProductNDC>65162-519</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Calcitriol</ProprietaryName>
<NonProprietaryName>Calcitriol</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170618</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203289</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>CALCITRIOL</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Cholecalciferol [CS], Vitamin D3 Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170618</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Predialysis Patients. Calcitriol capsules re indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 to 55 mL/min) not yet on dialysis. In children, the creatinine clearance value must be corrected for a surface area of 1.73 square meters. A serum iPTH level of ≥100 pg/mL is strongly suggestive of secondary hyperparathyroidism. Dialysis Patients. Calcitriol capsules are indicated in the management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis. In these patients, calcitriol capsules administration enhances calcium absorption, reduces serum alkaline phosphatase levels, and may reduce elevated parathyroid hormone levels and the histological manifestations of osteitis fibrosa cystica and defective mineralization. Hypoparathyroidism Patients. Calcitriol capsules are also indicated in the management of hypocalcemia and its clinical manifestations in patients with postsurgical hypoparathyroidism, idiopathic hypoparathyroidism, and pseudohypoparathyroidism.</IndicationAndUsage>
<Description>Calcitriol is a synthetic vitamin D analog which is active in the regulation of the absorption of calcium from the gastrointestinal tract and its utilization in the body. Calcitriol capsules are available as containing either 0.25 mcg or 0.5 mcg calcitriol, USP. Calcitriol capsules contain butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT) as antioxidants. The capsules also contain medium chain triglycerides. Gelatin capsule shells contain FD&C Yellow No. 6, gelatin, glycerin, methyl paraben sodium, propyl paraben sodium, purified water, and titanium dioxide. The 0.5 mcg capsules also contain FD&C Red No. 40. Calcitriol, USP is a white, crystalline compound which occurs naturally in humans. It has a calculated molecular weight of 416.65 and is soluble in organic solvents but relatively insoluble in water. Chemically, calcitriol, USP is 9,10- seco(5Z,7E)-5,7,10(19)-cholestatriene-1α, 3β, 25-triol and has the following structural formula. The other names frequently used for calcitriol, USP are 1α,25-dihydroxycholecalciferol, 1,25-dihydroxyvitamin D3, 1,25-DHCC, 1,25(OH)2D3 and 1,25-diOHC.</Description>
</NDC>
<NDC>
<NDCCode>65162-519-25</NDCCode>
<PackageDescription>250 CAPSULE in 1 BOTTLE (65162-519-25) </PackageDescription>
<NDC11Code>65162-0519-25</NDC11Code>
<ProductNDC>65162-519</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Calcitriol</ProprietaryName>
<NonProprietaryName>Calcitriol</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170618</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203289</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>CALCITRIOL</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Cholecalciferol [CS], Vitamin D3 Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170618</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Predialysis Patients. Calcitriol capsules re indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 to 55 mL/min) not yet on dialysis. In children, the creatinine clearance value must be corrected for a surface area of 1.73 square meters. A serum iPTH level of ≥100 pg/mL is strongly suggestive of secondary hyperparathyroidism. Dialysis Patients. Calcitriol capsules are indicated in the management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis. In these patients, calcitriol capsules administration enhances calcium absorption, reduces serum alkaline phosphatase levels, and may reduce elevated parathyroid hormone levels and the histological manifestations of osteitis fibrosa cystica and defective mineralization. Hypoparathyroidism Patients. Calcitriol capsules are also indicated in the management of hypocalcemia and its clinical manifestations in patients with postsurgical hypoparathyroidism, idiopathic hypoparathyroidism, and pseudohypoparathyroidism.</IndicationAndUsage>
<Description>Calcitriol is a synthetic vitamin D analog which is active in the regulation of the absorption of calcium from the gastrointestinal tract and its utilization in the body. Calcitriol capsules are available as containing either 0.25 mcg or 0.5 mcg calcitriol, USP. Calcitriol capsules contain butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT) as antioxidants. The capsules also contain medium chain triglycerides. Gelatin capsule shells contain FD&C Yellow No. 6, gelatin, glycerin, methyl paraben sodium, propyl paraben sodium, purified water, and titanium dioxide. The 0.5 mcg capsules also contain FD&C Red No. 40. Calcitriol, USP is a white, crystalline compound which occurs naturally in humans. It has a calculated molecular weight of 416.65 and is soluble in organic solvents but relatively insoluble in water. Chemically, calcitriol, USP is 9,10- seco(5Z,7E)-5,7,10(19)-cholestatriene-1α, 3β, 25-triol and has the following structural formula. The other names frequently used for calcitriol, USP are 1α,25-dihydroxycholecalciferol, 1,25-dihydroxyvitamin D3, 1,25-DHCC, 1,25(OH)2D3 and 1,25-diOHC.</Description>
</NDC>
<NDC>
<NDCCode>69423-519-73</NDCCode>
<PackageDescription>1 CANISTER in 1 CARTON (69423-519-73) > 73 g in 1 CANISTER</PackageDescription>
<NDC11Code>69423-0519-73</NDC11Code>
<ProductNDC>69423-519</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Old Spice Sweat Defense Knockout Soft</ProprietaryName>
<NonProprietaryName>Aluminum Zirconium Trichlorohydrex Gly</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201222</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part350</ApplicationNumber>
<LabelerName>The Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY</SubstanceName>
<StrengthNumber>19</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces underarm wetness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84515-519-01</NDCCode>
<PackageDescription>50 g in 1 BOX (84515-519-01) </PackageDescription>
<NDC11Code>84515-0519-01</NDC11Code>
<ProductNDC>84515-519</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Retinol Collagen</ProprietaryName>
<NonProprietaryName>Retinol Collagen</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241017</StartMarketingDate>
<EndMarketingDate>20311231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Yiwu Xinqian E Commerce Co Ltd</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20241017</StartMarketingDatePackage>
<EndMarketingDatePackage>20311231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84682-519-01</NDCCode>
<PackageDescription>50 mL in 1 BOX (84682-519-01) </PackageDescription>
<NDC11Code>84682-0519-01</NDC11Code>
<ProductNDC>84682-519</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Trstay Hair Growth Oil</ProprietaryName>
<NonProprietaryName>Trstay Hair Growth Oil</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241022</StartMarketingDate>
<EndMarketingDate>20311031</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M032</ApplicationNumber>
<LabelerName>Yiwu Yucheng E Commerce Co Ltd</LabelerName>
<SubstanceName>MINOXIDIL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20241022</StartMarketingDatePackage>
<EndMarketingDatePackage>20311031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>17478-151-42</NDCCode>
<PackageDescription>1 VIAL in 1 BOX, UNIT-DOSE (17478-151-42) > 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>17478-0151-42</NDC11Code>
<ProductNDC>17478-151</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rifampin</ProprietaryName>
<NonProprietaryName>Rifampin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20120601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065502</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>RIFAMPIN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Rifamycin Antibacterial [EPC], Rifamycins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.</IndicationAndUsage>
<Description>Rifampin for injection USP contains rifampin 600 mg, sodium formaldehyde sulfoxylate dihydrate 10 mg, and sodium hydroxide to adjust pH. Rifampin for injection is a sterile, lyophilized powder for intravenous infusion only. Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either:. 3-[[(4-Methyl-1-piperazinyl)imino]methyl]rifamycin. or. 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,20,22–heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7- (epoxypentadeca[1,11,13]trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>17478-831-01</NDCCode>
<PackageDescription>10 AMPULE in 1 CARTON (17478-831-01) > 1 mL in 1 AMPULE</PackageDescription>
<NDC11Code>17478-0831-01</NDC11Code>
<ProductNDC>17478-831</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Calcitriol</ProprietaryName>
<NonProprietaryName>Calcitriol</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20130322</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078066</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>CALCITRIOL</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Cholecalciferol [CS], Vitamin D3 Analog [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130322</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Calcitriol injection is indicated in the management of hypocalcemia in patients undergoing chronic renal dialysis. It has been shown to significantly reduce elevated parathyroid hormone levels. Reduction of PTH has been shown to result in an improvement in renal osteodystrophy.</IndicationAndUsage>
<Description>Calcitriol Injection is synthetically manufactured calcitriol and is available as a sterile, isotonic, clear, colorless to yellow, aqueous solution for intravenous injection. Calcitriol Injection, USP is available in 1 mL ampules. Each 1 mL contains: Active: Calcitriol, 1 mcg. Inactives: Dibasic Sodium Phosphate, Anhydrous 7.6 mg; Edetate Disodium, Dihydrate 1.1 mg; Monobasic Sodium Phosphate, Monohydrate 1.8 mg; Polysorbate 20, 4 mg; Sodium Ascorbate 10 mg; Sodium Chloride 1.5 mg; pH Range is from 6.5 to 8.0 and Water for Injection. Calcitriol is a colorless, crystalline compound which occurs naturally in humans. It is soluble in organic solvents but relatively insoluble in water. Calcitriol is chemically designated (5Z, 7E)-9,10 secocholesta 5,7,10(19)-triene-1α, 3β, 25-triol and has the following structural formula:. The other names frequently used for calcitriol are 1α,25-dihydroxycholecalciferol,1α, 25-dihydroxyvitamin D3,1,25-DHCC,1,25(OH)2D3 and 1,25-diOHC.</Description>
</NDC>
<NDC>
<NDCCode>17478-931-01</NDCCode>
<PackageDescription>10 AMPULE in 1 CARTON (17478-931-01) > 1 mL in 1 AMPULE</PackageDescription>
<NDC11Code>17478-0931-01</NDC11Code>
<ProductNDC>17478-931</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Calcitriol</ProprietaryName>
<NonProprietaryName>Calcitriol</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20111014</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078066</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>CALCITRIOL</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Cholecalciferol [CS], Vitamin D3 Analog [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111014</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Calcitriol injection is indicated in the management of hypocalcemia in patients undergoing chronic renal dialysis. It has been shown to significantly reduce elevated parathyroid hormone levels. Reduction of PTH has been shown to result in an improvement in renal osteodystrophy.</IndicationAndUsage>
<Description>Calcitriol injection is synthetically manufactured calcitriol and is available as a sterile, isotonic, clear, colorless to yellow, aqueous solution for intravenous injection. Calcitriol Injection, USP is available in 1 mL ampules. Each 1 mL contains: Active: Calcitriol, 1 or 2 mcg. Inactives: Dibasic Sodium Phosphate, Anhydrous 7.6 mg; Edetate Disodium, Dihydrate 1.1 mg; Monobasic Sodium Phosphate, Monohydrate 1.8 mg; Polysorbate 20, 4 mg; Sodium Ascorbate 10 mg; Sodium Chloride 1.5 mg; pH Range is from 6.5 to 8.0 and Water for Injection. Calcitriol is a colorless, crystalline compound which occurs naturally in humans. It is soluble in organic solvents but relatively insoluble in water. Calcitriol is chemically designated (5Z,7E)-9,10 secocholesta-5,7,10(19)-triene-1α, 3β, 25-triol and has the following structural formula:. The other names frequently used for calcitriol are 1α,25-dihydroxycholecalciferol,1α,25-dihydroxyvitamin D3 ,1,25-DHCC,1,25(OH)2D3 and 1,25-diOHC.</Description>
</NDC>
<NDC>
<NDCCode>17478-932-01</NDCCode>
<PackageDescription>10 AMPULE in 1 CARTON (17478-932-01) > 1 mL in 1 AMPULE</PackageDescription>
<NDC11Code>17478-0932-01</NDC11Code>
<ProductNDC>17478-932</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Calcitriol</ProprietaryName>
<NonProprietaryName>Calcitriol</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20111014</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078066</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>CALCITRIOL</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Cholecalciferol [CS], Vitamin D3 Analog [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111014</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Calcitriol injection is indicated in the management of hypocalcemia in patients undergoing chronic renal dialysis. It has been shown to significantly reduce elevated parathyroid hormone levels. Reduction of PTH has been shown to result in an improvement in renal osteodystrophy.</IndicationAndUsage>
<Description>Calcitriol injection is synthetically manufactured calcitriol and is available as a sterile, isotonic, clear, colorless to yellow, aqueous solution for intravenous injection. Calcitriol Injection, USP is available in 1 mL ampules. Each 1 mL contains: Active: Calcitriol, 1 or 2 mcg. Inactives: Dibasic Sodium Phosphate, Anhydrous 7.6 mg; Edetate Disodium, Dihydrate 1.1 mg; Monobasic Sodium Phosphate, Monohydrate 1.8 mg; Polysorbate 20, 4 mg; Sodium Ascorbate 10 mg; Sodium Chloride 1.5 mg; pH Range is from 6.5 to 8.0 and Water for Injection. Calcitriol is a colorless, crystalline compound which occurs naturally in humans. It is soluble in organic solvents but relatively insoluble in water. Calcitriol is chemically designated (5Z,7E)-9,10 secocholesta-5,7,10(19)-triene-1α, 3β, 25-triol and has the following structural formula:. The other names frequently used for calcitriol are 1α,25-dihydroxycholecalciferol,1α,25-dihydroxyvitamin D3 ,1,25-DHCC,1,25(OH)2D3 and 1,25-diOHC.</Description>
</NDC>
<NDC>
<NDCCode>0944-2815-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0944-2815-01) * 50 mL in 1 VIAL (0944-2804-04) * 50 mL in 1 VIAL, GLASS (64764-519-50) </PackageDescription>
<NDC11Code>00944-2815-01</NDC11Code>
<ProductNDC>0944-2815</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Aralast</ProprietaryName>
<ProprietaryNameSuffix>Np</ProprietaryNameSuffix>
<NonProprietaryName>Alpha-1-proteinase Inhibitor (human)</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20021223</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125039</ApplicationNumber>
<LabelerName>Takeda Pharmaceuticals America, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20021223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ARALAST NP is an Alpha1-Proteinase Inhibitor (Alpha1-PI) indicated for chronic augmentation therapy in adults with clinically evident emphysema due to severe congenital deficiency of Alpha1-PI (alpha1-antitrypsin deficiency). ARALAST NP increases antigenic and functional (anti-neutrophil elastase capacity, ANEC) serum levels and antigenic lung epithelial lining fluid levels of Alpha1-PI. The effect of augmentation therapy with any Alpha1-PI, including ARALAST NP, on pulmonary exacerbations and on the progression of emphysema in alpha1-antitrypsin deficiency has not been conclusively demonstrated in randomized, controlled clinical trials. Clinical data demonstrating the long-term effects of chronic augmentation and maintenance therapy with ARALAST NP or ARALAST are not available. ARALAST NP is not indicated as therapy for lung disease in patients in whom severe congenital Alpha1-PI deficiency has not been established.</IndicationAndUsage>
<Description>ARALAST NP contains approximately 2% Alpha1-PI with truncated C-terminal lysine (removal of Lys394), whereas ARALAST contains approximately 67% Alpha1-PI with the C-terminal lysine truncation.8 No known data suggest influence of these structural modifications on the functional activity and immunogenicity of Alpha1-PI.9. ARALAST NP is a sterile, lyophilized preparation of purified human alpha1-proteinase inhibitor (Alpha1-PI), also known as alpha1-antitrypsin (AAT).1 ARALAST NP is a similar product to ARALAST, containing the same active components of plasma Alpha1-PI with identical formulations. ARALAST NP is prepared from large pools of human plasma by using the cold ethanol fractionation process, followed by purification steps including polyethylene glycol and zinc chloride precipitations and ion exchange chromatography. To reduce the risk of viral transmission, the manufacturing process includes treatment with a solvent detergent (S/D) mixture [tri-n-butyl phosphate and polysorbate 80] to inactivate enveloped viral agents such as human immunodeficiency virus (HIV), hepatitis B (HBV), and hepatitis C (HCV). In addition, a nanofiltration step is incorporated into the manufacturing process to reduce the risk of transmission of enveloped and non-enveloped viral agents. Based on in vitro studies, the process used to produce ARALAST NP has been shown to inactivate and/or partition various viruses as shown in Table 3 below. The unreconstituted, lyophilized cake should be white or off-white to slightly yellow-green or yellow in color. When reconstituted as directed, the concentration of functionally active Alpha1-PI is 16.0 – 26.0 mg/mL and the specific activity is ≥0.55 mg active Alpha1-PI/mg total protein. The composition of the reconstituted product is as follows. Each vial of ARALAST NP has the functional activity, as determined by inhibition of porcine pancreatic elastase, stated on the label. The formulation contains no preservative. The pH of the solution ranges from 7.2 to 7.8. Product must only be administered intravenously.</Description>
</NDC>
<NDC>
<NDCCode>10812-519-01</NDCCode>
<PackageDescription>1 APPLICATOR in 1 BLISTER PACK (10812-519-01) / 1.4 g in 1 APPLICATOR</PackageDescription>
<NDC11Code>10812-0519-01</NDC11Code>
<ProductNDC>10812-519</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neutrogena</ProprietaryName>
<ProprietaryNameSuffix>Skin Clearing Blemish Concealer - Fair 05</ProprietaryNameSuffix>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100205</StartMarketingDate>
<EndMarketingDate>20250831</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M006</ApplicationNumber>
<LabelerName>Johnson & Johnson Consumer Inc.</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>5.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-09-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20100205</StartMarketingDatePackage>
<EndMarketingDatePackage>20250831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the treatment of acne.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11344-519-18</NDCCode>
<PackageDescription>70 g in 1 JAR (11344-519-18) </PackageDescription>
<NDC11Code>11344-0519-18</NDC11Code>
<ProductNDC>11344-519</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Petroleum</ProprietaryName>
<NonProprietaryName>White Petrolatum</NonProprietaryName>
<DosageFormName>JELLY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20090512</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>Vi-Jon, LLC</LabelerName>
<SubstanceName>PETROLATUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090512</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>11344-519-27</NDCCode>
<PackageDescription>368 g in 1 JAR (11344-519-27) </PackageDescription>
<NDC11Code>11344-0519-27</NDC11Code>
<ProductNDC>11344-519</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Petroleum</ProprietaryName>
<NonProprietaryName>White Petrolatum</NonProprietaryName>
<DosageFormName>JELLY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20090512</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>Vi-Jon, LLC</LabelerName>
<SubstanceName>PETROLATUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090512</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>