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"Description": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL."
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"Description": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL."
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"Description": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL."
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{
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"Description": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL."
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"Description": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL."
},
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"Description": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL."
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"Description": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL."
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"IndicationAndUsage": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) Extracts are allergenic extracts indicated for: : 1 skin test diagnosis of mite allergy, 2 treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis.",
"Description": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL."
},
{
"NDCCode": "22840-0039-8",
"PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (22840-0039-8) ",
"NDC11Code": "22840-0039-08",
"ProductNDC": "22840-0039",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Standardized Mite Dermatophagoides Pteronyssinus",
"NonProprietaryName": "Dermatophagoides Pteronyssinus",
"DosageFormName": "CONCENTRATE",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "20100203",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101835",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "DERMATOPHAGOIDES PTERONYSSINUS",
"StrengthNumber": "30000",
"StrengthUnit": "[AU]/mL",
"Pharm_Classes": "Allergens [CS], Antigens, Dermatophagoides [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Insect Proteins [CS], Standardized Insect Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-02-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20100203",
"SamplePackage": "N",
"IndicationAndUsage": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) Extracts are allergenic extracts indicated for: : 1 skin test diagnosis of mite allergy, 2 treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis.",
"Description": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL."
},
{
"NDCCode": "22840-0040-8",
"PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (22840-0040-8) ",
"NDC11Code": "22840-0040-08",
"ProductNDC": "22840-0040",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Standardized Mite Mix Dermatophagoides Farinae And Dermatophagoides Pteronyssinus",
"NonProprietaryName": "Dermatophagoides Farinae And Dermatophagoides Pteronyssinus",
"DosageFormName": "CONCENTRATE",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "20100203",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101834",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS",
"StrengthNumber": "15000; 15000",
"StrengthUnit": "[AU]/mL; [AU]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Antigens, Dermatophagoides [CS], Antigens, Dermatophagoides [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Insect Proteins [CS], Insect Proteins [CS], Standardized Insect Allergenic Extract [EPC], Standardized Insect Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-02-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20100203",
"SamplePackage": "N",
"IndicationAndUsage": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) Extracts are allergenic extracts indicated for: : 1 skin test diagnosis of mite allergy, 2 treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis.",
"Description": "Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL."
},
{
"NDCCode": "0085-1328-01",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (0085-1328-01) / 105 mL in 1 BOTTLE, GLASS",
"NDC11Code": "00085-1328-01",
"ProductNDC": "0085-1328",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Noxafil",
"NonProprietaryName": "Posaconazole",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20060915",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022003",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "POSACONAZOLE",
"StrengthNumber": "40",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"Status": "Active",
"LastUpdate": "2026-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20060915",
"SamplePackage": "N",
"IndicationAndUsage": "Noxafil is an azole antifungal indicated as follows: 1 Noxafil is indicated for the treatment of invasive aspergillosis as follows: (1.1) Noxafil injection: adults and pediatric patients 2 years of age and older who weigh 10 kg or greaterNoxafil delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kgNoxafil PowderMix for delayed-release oral suspension: pediatric patients 2 years of age and older who weigh 10 kg to 40 kg, 2 Noxafil is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy as follows: (1.2) Noxafil injection: adults and pediatric patients 2 years of age and older who weigh 10 kg or greater.Noxafil delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kgNoxafil oral suspension: adults and pediatric patients 13 years of age and olderNoxafil PowderMix for delayed-release oral suspension: pediatric patients 2 years of age and older who weigh 10 kg to 40 kg.",
"Description": "Noxafil and Noxafil PowderMix contain posaconazole, an azole antifungal agent. Posaconazole is designated chemically as 4-[4-[4-[4-[[ (3R,5R)-5- (2,4-difluorophenyl)tetrahydro-5- (1H-1,2,4-triazol-1-ylmethyl)-3-furanyl]methoxy]phenyl]-1-piperazinyl]phenyl]-2-[(1S,2S)-1-ethyl-2-hydroxypropyl]-2,4-dihydro-3H-1,2,4-triazol-3-one with an empirical formula of C37H42F2N8O4 and a molecular weight of 700.8. The chemical structure is. Posaconazole is a white powder with a low aqueous solubility. Noxafil (posaconazole) Injection. Noxafil injection, for intravenous use, is a clear colorless to yellow, without preservatives sterile liquid essentially free of foreign matter. Each vial contains 300 mg of posaconazole and the following inactive ingredients: 6.68 g Betadex Sulfobutyl Ether Sodium (SBECD), 0.0033 g edetate disodium, hydrochloric acid and sodium hydroxide to adjust the pH to 2.6, and water for injection. Noxafil (posaconazole) Delayed-Release Tablets. Noxafil delayed-release tablet, for oral use, is yellow, coated, and oblong and contains 100 mg of posaconazole. Each delayed-release tablet contains the following inactive ingredients: croscarmellose sodium, hydroxypropylcellulose, hypromellose acetate succinate, iron oxide yellow, Macrogol/PEG 3350, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol partially hydrolyzed, silicon dioxide, talc, and titanium dioxide. Noxafil (posaconazole) Oral Suspension. Noxafil oral suspension is a white, cherry-flavored immediate-release suspension that contains 40 mg of posaconazole per mL and the following inactive ingredients: artificial cherry flavor, citric acid monohydrate, glycerin, liquid glucose, polysorbate 80, purified water, simethicone, sodium benzoate, sodium citrate dihydrate, titanium dioxide, and xanthan gum. Noxafil PowderMix (posaconazole) for Delayed-Release Oral Suspension. Noxafil PowderMix for delayed-release oral suspension is supplied as a component of a kit. Each kit contains Noxafil as an off-white to yellowish powder for delayed-release oral suspension, a bottle of mixing liquid, two 3 mL (green) notched tip syringes, two 10 mL (blue) notched tip syringes, two mixing cups, and one bottle adapter for the mixing liquid bottle. : 1 Noxafil PowderMix for delayed-release oral suspension contains 300 mg of posaconazole and the following inactive ingredient: hypromellose acetate succinate., 2 The mixing liquid contains: anhydrous citric acid, antifoam Af emulsion, berry citrus sweet flavor, carboxymethylcellulose sodium, carrageenan calcium sulfate trisodium phosphate, glycerin, methylparaben, microcrystalline cellulose, potassium sorbate, propylparaben, purified water, sodium citrate, sodium phosphate monobasic monohydrate, sodium saccharin, sorbitol solution, and xanthan gum."
},
{
"NDCCode": "0085-2224-02",
"PackageDescription": "8 PACKET in 1 CARTON (0085-2224-02) / 1 POWDER, FOR SUSPENSION in 1 PACKET (0085-2224-01) ",
"NDC11Code": "00085-2224-02",
"ProductNDC": "0085-2224",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Noxafil",
"NonProprietaryName": "Posaconazole",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20210608",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA214770",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "POSACONAZOLE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"Status": "Active",
"LastUpdate": "2026-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210608",
"SamplePackage": "N",
"IndicationAndUsage": "Noxafil is an azole antifungal indicated as follows: 1 Noxafil is indicated for the treatment of invasive aspergillosis as follows: (1.1) Noxafil injection: adults and pediatric patients 2 years of age and older who weigh 10 kg or greaterNoxafil delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kgNoxafil PowderMix for delayed-release oral suspension: pediatric patients 2 years of age and older who weigh 10 kg to 40 kg, 2 Noxafil is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy as follows: (1.2) Noxafil injection: adults and pediatric patients 2 years of age and older who weigh 10 kg or greater.Noxafil delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kgNoxafil oral suspension: adults and pediatric patients 13 years of age and olderNoxafil PowderMix for delayed-release oral suspension: pediatric patients 2 years of age and older who weigh 10 kg to 40 kg.",
"Description": "Noxafil and Noxafil PowderMix contain posaconazole, an azole antifungal agent. Posaconazole is designated chemically as 4-[4-[4-[4-[[ (3R,5R)-5- (2,4-difluorophenyl)tetrahydro-5- (1H-1,2,4-triazol-1-ylmethyl)-3-furanyl]methoxy]phenyl]-1-piperazinyl]phenyl]-2-[(1S,2S)-1-ethyl-2-hydroxypropyl]-2,4-dihydro-3H-1,2,4-triazol-3-one with an empirical formula of C37H42F2N8O4 and a molecular weight of 700.8. The chemical structure is. Posaconazole is a white powder with a low aqueous solubility. Noxafil (posaconazole) Injection. Noxafil injection, for intravenous use, is a clear colorless to yellow, without preservatives sterile liquid essentially free of foreign matter. Each vial contains 300 mg of posaconazole and the following inactive ingredients: 6.68 g Betadex Sulfobutyl Ether Sodium (SBECD), 0.0033 g edetate disodium, hydrochloric acid and sodium hydroxide to adjust the pH to 2.6, and water for injection. Noxafil (posaconazole) Delayed-Release Tablets. Noxafil delayed-release tablet, for oral use, is yellow, coated, and oblong and contains 100 mg of posaconazole. Each delayed-release tablet contains the following inactive ingredients: croscarmellose sodium, hydroxypropylcellulose, hypromellose acetate succinate, iron oxide yellow, Macrogol/PEG 3350, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol partially hydrolyzed, silicon dioxide, talc, and titanium dioxide. Noxafil (posaconazole) Oral Suspension. Noxafil oral suspension is a white, cherry-flavored immediate-release suspension that contains 40 mg of posaconazole per mL and the following inactive ingredients: artificial cherry flavor, citric acid monohydrate, glycerin, liquid glucose, polysorbate 80, purified water, simethicone, sodium benzoate, sodium citrate dihydrate, titanium dioxide, and xanthan gum. Noxafil PowderMix (posaconazole) for Delayed-Release Oral Suspension. Noxafil PowderMix for delayed-release oral suspension is supplied as a component of a kit. Each kit contains Noxafil as an off-white to yellowish powder for delayed-release oral suspension, a bottle of mixing liquid, two 3 mL (green) notched tip syringes, two 10 mL (blue) notched tip syringes, two mixing cups, and one bottle adapter for the mixing liquid bottle. : 1 Noxafil PowderMix for delayed-release oral suspension contains 300 mg of posaconazole and the following inactive ingredient: hypromellose acetate succinate., 2 The mixing liquid contains: anhydrous citric acid, antifoam Af emulsion, berry citrus sweet flavor, carboxymethylcellulose sodium, carrageenan calcium sulfate trisodium phosphate, glycerin, methylparaben, microcrystalline cellulose, potassium sorbate, propylparaben, purified water, sodium citrate, sodium phosphate monobasic monohydrate, sodium saccharin, sorbitol solution, and xanthan gum."
},
{
"NDCCode": "0085-4324-02",
"PackageDescription": "60 TABLET, COATED in 1 BOTTLE (0085-4324-02) ",
"NDC11Code": "00085-4324-02",
"ProductNDC": "0085-4324",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Noxafil",
"NonProprietaryName": "Posaconazole",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20131125",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205053",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "POSACONAZOLE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"Status": "Active",
"LastUpdate": "2026-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20131125",
"SamplePackage": "N",
"IndicationAndUsage": "Noxafil is an azole antifungal indicated as follows: 1 Noxafil is indicated for the treatment of invasive aspergillosis as follows: (1.1) Noxafil injection: adults and pediatric patients 2 years of age and older who weigh 10 kg or greaterNoxafil delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kgNoxafil PowderMix for delayed-release oral suspension: pediatric patients 2 years of age and older who weigh 10 kg to 40 kg, 2 Noxafil is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy as follows: (1.2) Noxafil injection: adults and pediatric patients 2 years of age and older who weigh 10 kg or greater.Noxafil delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kgNoxafil oral suspension: adults and pediatric patients 13 years of age and olderNoxafil PowderMix for delayed-release oral suspension: pediatric patients 2 years of age and older who weigh 10 kg to 40 kg.",
"Description": "Noxafil and Noxafil PowderMix contain posaconazole, an azole antifungal agent. Posaconazole is designated chemically as 4-[4-[4-[4-[[ (3R,5R)-5- (2,4-difluorophenyl)tetrahydro-5- (1H-1,2,4-triazol-1-ylmethyl)-3-furanyl]methoxy]phenyl]-1-piperazinyl]phenyl]-2-[(1S,2S)-1-ethyl-2-hydroxypropyl]-2,4-dihydro-3H-1,2,4-triazol-3-one with an empirical formula of C37H42F2N8O4 and a molecular weight of 700.8. The chemical structure is. Posaconazole is a white powder with a low aqueous solubility. Noxafil (posaconazole) Injection. Noxafil injection, for intravenous use, is a clear colorless to yellow, without preservatives sterile liquid essentially free of foreign matter. Each vial contains 300 mg of posaconazole and the following inactive ingredients: 6.68 g Betadex Sulfobutyl Ether Sodium (SBECD), 0.0033 g edetate disodium, hydrochloric acid and sodium hydroxide to adjust the pH to 2.6, and water for injection. Noxafil (posaconazole) Delayed-Release Tablets. Noxafil delayed-release tablet, for oral use, is yellow, coated, and oblong and contains 100 mg of posaconazole. Each delayed-release tablet contains the following inactive ingredients: croscarmellose sodium, hydroxypropylcellulose, hypromellose acetate succinate, iron oxide yellow, Macrogol/PEG 3350, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol partially hydrolyzed, silicon dioxide, talc, and titanium dioxide. Noxafil (posaconazole) Oral Suspension. Noxafil oral suspension is a white, cherry-flavored immediate-release suspension that contains 40 mg of posaconazole per mL and the following inactive ingredients: artificial cherry flavor, citric acid monohydrate, glycerin, liquid glucose, polysorbate 80, purified water, simethicone, sodium benzoate, sodium citrate dihydrate, titanium dioxide, and xanthan gum. Noxafil PowderMix (posaconazole) for Delayed-Release Oral Suspension. Noxafil PowderMix for delayed-release oral suspension is supplied as a component of a kit. Each kit contains Noxafil as an off-white to yellowish powder for delayed-release oral suspension, a bottle of mixing liquid, two 3 mL (green) notched tip syringes, two 10 mL (blue) notched tip syringes, two mixing cups, and one bottle adapter for the mixing liquid bottle. : 1 Noxafil PowderMix for delayed-release oral suspension contains 300 mg of posaconazole and the following inactive ingredient: hypromellose acetate succinate., 2 The mixing liquid contains: anhydrous citric acid, antifoam Af emulsion, berry citrus sweet flavor, carboxymethylcellulose sodium, carrageenan calcium sulfate trisodium phosphate, glycerin, methylparaben, microcrystalline cellulose, potassium sorbate, propylparaben, purified water, sodium citrate, sodium phosphate monobasic monohydrate, sodium saccharin, sorbitol solution, and xanthan gum."
},
{
"NDCCode": "0085-4331-01",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (0085-4331-01) / 16.7 mL in 1 VIAL, GLASS",
"NDC11Code": "00085-4331-01",
"ProductNDC": "0085-4331",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Noxafil",
"NonProprietaryName": "Posaconazole",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20140313",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205596",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "POSACONAZOLE",
"StrengthNumber": "18",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"Status": "Active",
"LastUpdate": "2026-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140313",
"SamplePackage": "N",
"IndicationAndUsage": "Noxafil is an azole antifungal indicated as follows: 1 Noxafil is indicated for the treatment of invasive aspergillosis as follows: (1.1) Noxafil injection: adults and pediatric patients 2 years of age and older who weigh 10 kg or greaterNoxafil delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kgNoxafil PowderMix for delayed-release oral suspension: pediatric patients 2 years of age and older who weigh 10 kg to 40 kg, 2 Noxafil is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy as follows: (1.2) Noxafil injection: adults and pediatric patients 2 years of age and older who weigh 10 kg or greater.Noxafil delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kgNoxafil oral suspension: adults and pediatric patients 13 years of age and olderNoxafil PowderMix for delayed-release oral suspension: pediatric patients 2 years of age and older who weigh 10 kg to 40 kg.",
"Description": "Noxafil and Noxafil PowderMix contain posaconazole, an azole antifungal agent. Posaconazole is designated chemically as 4-[4-[4-[4-[[ (3R,5R)-5- (2,4-difluorophenyl)tetrahydro-5- (1H-1,2,4-triazol-1-ylmethyl)-3-furanyl]methoxy]phenyl]-1-piperazinyl]phenyl]-2-[(1S,2S)-1-ethyl-2-hydroxypropyl]-2,4-dihydro-3H-1,2,4-triazol-3-one with an empirical formula of C37H42F2N8O4 and a molecular weight of 700.8. The chemical structure is. Posaconazole is a white powder with a low aqueous solubility. Noxafil (posaconazole) Injection. Noxafil injection, for intravenous use, is a clear colorless to yellow, without preservatives sterile liquid essentially free of foreign matter. Each vial contains 300 mg of posaconazole and the following inactive ingredients: 6.68 g Betadex Sulfobutyl Ether Sodium (SBECD), 0.0033 g edetate disodium, hydrochloric acid and sodium hydroxide to adjust the pH to 2.6, and water for injection. Noxafil (posaconazole) Delayed-Release Tablets. Noxafil delayed-release tablet, for oral use, is yellow, coated, and oblong and contains 100 mg of posaconazole. Each delayed-release tablet contains the following inactive ingredients: croscarmellose sodium, hydroxypropylcellulose, hypromellose acetate succinate, iron oxide yellow, Macrogol/PEG 3350, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol partially hydrolyzed, silicon dioxide, talc, and titanium dioxide. Noxafil (posaconazole) Oral Suspension. Noxafil oral suspension is a white, cherry-flavored immediate-release suspension that contains 40 mg of posaconazole per mL and the following inactive ingredients: artificial cherry flavor, citric acid monohydrate, glycerin, liquid glucose, polysorbate 80, purified water, simethicone, sodium benzoate, sodium citrate dihydrate, titanium dioxide, and xanthan gum. Noxafil PowderMix (posaconazole) for Delayed-Release Oral Suspension. Noxafil PowderMix for delayed-release oral suspension is supplied as a component of a kit. Each kit contains Noxafil as an off-white to yellowish powder for delayed-release oral suspension, a bottle of mixing liquid, two 3 mL (green) notched tip syringes, two 10 mL (blue) notched tip syringes, two mixing cups, and one bottle adapter for the mixing liquid bottle. : 1 Noxafil PowderMix for delayed-release oral suspension contains 300 mg of posaconazole and the following inactive ingredient: hypromellose acetate succinate., 2 The mixing liquid contains: anhydrous citric acid, antifoam Af emulsion, berry citrus sweet flavor, carboxymethylcellulose sodium, carrageenan calcium sulfate trisodium phosphate, glycerin, methylparaben, microcrystalline cellulose, potassium sorbate, propylparaben, purified water, sodium citrate, sodium phosphate monobasic monohydrate, sodium saccharin, sorbitol solution, and xanthan gum."
},
{
"NDCCode": "11822-0033-1",
"PackageDescription": "80 LOZENGE in 1 BAG (11822-0033-1) ",
"NDC11Code": "11822-0033-01",
"ProductNDC": "11822-0033",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cherry Cough Drop",
"NonProprietaryName": "Menthol",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20150424",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Rite Aid",
"SubstanceName": "MENTHOL",
"StrengthNumber": "5.8",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20150424",
"SamplePackage": "N",
"IndicationAndUsage": "Uses temporarily relieves. cough as may occur with a cold. occasional minor irritation and sore throat."
},
{
"NDCCode": "12022-033-00",
"PackageDescription": "1 BOTTLE in 1 BOX (12022-033-00) / 74 mL in 1 BOTTLE",
"NDC11Code": "12022-0033-00",
"ProductNDC": "12022-033",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sulfur 8 Scalp Therapy Medicated Dandruff Control Leave-in Soothing Treatment",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M032",
"LabelerName": "J. Strickland and Co.",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "30",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2023-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200101",
"SamplePackage": "N",
"IndicationAndUsage": "for relief of scalp itching, irritation, redness, scaling and flaking associated with dandruff, seborrheic dermatitis, psoriasis."
},
{
"NDCCode": "21695-033-12",
"PackageDescription": "12 CAPSULE in 1 BOTTLE (21695-033-12)",
"NDC11Code": "21695-0033-12",
"ProductNDC": "21695-033",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin Hydrochloride",
"NonProprietaryName": "Clindamycin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20010202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065061",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "CLINDAMYCIN HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules and other antibacterial drugs, clindamycin hydrochloride capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the WARNING box, before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin.",
"Description": "Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside monohydrochloride. The structural formula is represented below. C18H33ClN2O5SHCl M.W. 461.45. Clindamycin hydrochloride capsules, USP for oral administration contain clindamycin hydrochloride equivalent to 150 mg or 300 mg of clindamycin. Inactive ingredients: 150 mg - black iron oxide, corn starch, D&C yellow #10, FD&C blue no. 1, gelatin, lactose monohydrate, magnesium stearate, talc and titanium dioxide; 300 mg - black iron oxide, corn starch, FD&C blue no. 1, gelatin, lactose monohydrate, magnesium stearate, talc and titanium dioxide."
},
{
"NDCCode": "21695-033-21",
"PackageDescription": "21 CAPSULE in 1 BOTTLE (21695-033-21)",
"NDC11Code": "21695-0033-21",
"ProductNDC": "21695-033",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin Hydrochloride",
"NonProprietaryName": "Clindamycin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20010202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065061",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "CLINDAMYCIN HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules and other antibacterial drugs, clindamycin hydrochloride capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the WARNING box, before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin.",
"Description": "Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside monohydrochloride. The structural formula is represented below. C18H33ClN2O5SHCl M.W. 461.45. Clindamycin hydrochloride capsules, USP for oral administration contain clindamycin hydrochloride equivalent to 150 mg or 300 mg of clindamycin. Inactive ingredients: 150 mg - black iron oxide, corn starch, D&C yellow #10, FD&C blue no. 1, gelatin, lactose monohydrate, magnesium stearate, talc and titanium dioxide; 300 mg - black iron oxide, corn starch, FD&C blue no. 1, gelatin, lactose monohydrate, magnesium stearate, talc and titanium dioxide."
},
{
"NDCCode": "21695-033-28",
"PackageDescription": "28 CAPSULE in 1 BOTTLE (21695-033-28)",
"NDC11Code": "21695-0033-28",
"ProductNDC": "21695-033",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin Hydrochloride",
"NonProprietaryName": "Clindamycin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20010202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065061",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "CLINDAMYCIN HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules and other antibacterial drugs, clindamycin hydrochloride capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the WARNING box, before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin.",
"Description": "Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside monohydrochloride. The structural formula is represented below. C18H33ClN2O5SHCl M.W. 461.45. Clindamycin hydrochloride capsules, USP for oral administration contain clindamycin hydrochloride equivalent to 150 mg or 300 mg of clindamycin. Inactive ingredients: 150 mg - black iron oxide, corn starch, D&C yellow #10, FD&C blue no. 1, gelatin, lactose monohydrate, magnesium stearate, talc and titanium dioxide; 300 mg - black iron oxide, corn starch, FD&C blue no. 1, gelatin, lactose monohydrate, magnesium stearate, talc and titanium dioxide."
},
{
"NDCCode": "21695-033-40",
"PackageDescription": "40 CAPSULE in 1 BOTTLE (21695-033-40)",
"NDC11Code": "21695-0033-40",
"ProductNDC": "21695-033",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin Hydrochloride",
"NonProprietaryName": "Clindamycin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20010202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065061",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "CLINDAMYCIN HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules and other antibacterial drugs, clindamycin hydrochloride capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the WARNING box, before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin.",
"Description": "Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside monohydrochloride. The structural formula is represented below. C18H33ClN2O5SHCl M.W. 461.45. Clindamycin hydrochloride capsules, USP for oral administration contain clindamycin hydrochloride equivalent to 150 mg or 300 mg of clindamycin. Inactive ingredients: 150 mg - black iron oxide, corn starch, D&C yellow #10, FD&C blue no. 1, gelatin, lactose monohydrate, magnesium stearate, talc and titanium dioxide; 300 mg - black iron oxide, corn starch, FD&C blue no. 1, gelatin, lactose monohydrate, magnesium stearate, talc and titanium dioxide."
},
{
"NDCCode": "21695-033-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (21695-033-60)",
"NDC11Code": "21695-0033-60",
"ProductNDC": "21695-033",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin Hydrochloride",
"NonProprietaryName": "Clindamycin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20010202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065061",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "CLINDAMYCIN HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules and other antibacterial drugs, clindamycin hydrochloride capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the WARNING box, before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin.",
"Description": "Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside monohydrochloride. The structural formula is represented below. C18H33ClN2O5SHCl M.W. 461.45. Clindamycin hydrochloride capsules, USP for oral administration contain clindamycin hydrochloride equivalent to 150 mg or 300 mg of clindamycin. Inactive ingredients: 150 mg - black iron oxide, corn starch, D&C yellow #10, FD&C blue no. 1, gelatin, lactose monohydrate, magnesium stearate, talc and titanium dioxide; 300 mg - black iron oxide, corn starch, FD&C blue no. 1, gelatin, lactose monohydrate, magnesium stearate, talc and titanium dioxide."
},
{
"NDCCode": "21695-033-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (21695-033-90)",
"NDC11Code": "21695-0033-90",
"ProductNDC": "21695-033",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin Hydrochloride",
"NonProprietaryName": "Clindamycin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20010202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065061",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "CLINDAMYCIN HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules and other antibacterial drugs, clindamycin hydrochloride capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the WARNING box, before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin.",
"Description": "Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside monohydrochloride. The structural formula is represented below. C18H33ClN2O5SHCl M.W. 461.45. Clindamycin hydrochloride capsules, USP for oral administration contain clindamycin hydrochloride equivalent to 150 mg or 300 mg of clindamycin. Inactive ingredients: 150 mg - black iron oxide, corn starch, D&C yellow #10, FD&C blue no. 1, gelatin, lactose monohydrate, magnesium stearate, talc and titanium dioxide; 300 mg - black iron oxide, corn starch, FD&C blue no. 1, gelatin, lactose monohydrate, magnesium stearate, talc and titanium dioxide."
},
{
"NDCCode": "23359-033-16",
"PackageDescription": "473 mL in 1 BOTTLE (23359-033-16)",
"NDC11Code": "23359-0033-16",
"ProductNDC": "23359-033",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ninjacof-a",
"NonProprietaryName": "Ninjacof-a",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20141015",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Centurion Labs, LLC",
"SubstanceName": "ACETAMINOPHEN; CHLOPHEDIANOL HYDROCHLORIDE; PYRILAMINE MALEATE",
"StrengthNumber": "160; 12.5; 12.5",
"StrengthUnit": "mg/5mL; mg/5mL; mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: : 1 cough due to minor throat and bronchial irritation, 2 calms the cough control center and relieves coughing, 3 itching of the nose or throat, 4 itchy, watery eyes, 5 minor aches and pains, 6 temporarily reduces fever, 7 runny nose, 8 sneezing, 9 headache."
},
{
"NDCCode": "31722-033-30",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (31722-033-30) ",
"NDC11Code": "31722-0033-30",
"ProductNDC": "31722-033",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fesoterodine Fumarate",
"NonProprietaryName": "Fesoterodine Fumarate",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240109",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204792",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "FESOTERODINE FUMARATE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240109",
"SamplePackage": "N",
"IndicationAndUsage": "Fesoterodine fumarate extended-release tablets are indicated for the treatment of: Overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. ( 1.1). Neurogenic detrusor overactivity (NDO) in pediatric patients 6 years of age and older and weighing greater than 25 kg. (1.2).",
"Description": "Fesoterodine fumarate tablet contains fesoterodine fumarate and is an extended-release tablet. Fesoterodine is rapidly de-esterified to its active metabolite (R)-2-(3-diisopropylamino-1-phenylpropyl)-4-hydroxymethyl-phenol, or 5-hydroxymethyl tolterodine, which is a muscarinic receptor antagonist. Chemically, fesoterodine fumarate is designated as Isobutyric acid 2-((R)-3-diisopropylammonium-1-phenylpropyl)-4-(hydroxymethyl) phenyl ester hydrogen fumarate. The empirical formula is C 30H 41NO 7and its molecular weight is 527.66. The structural formula is:. Fesoterodine fumarate is a white to off-white powder, which is freely soluble in water and soluble in methanol. Each Fesoterodine fumarate extended-release tablet contains either 4 mg or 8 mg of fesoterodine fumarate and the following inactive ingredients: citric acid monohydrate, colloidal silicon dioxide, FD&C blue#2/ indigo carmine aluminum lake, glyceryl behenate, hypromellose, lecithin, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc and titanium dioxide. The botanical source for pregelatinized starch is maize starch."
},
{
"NDCCode": "31722-033-90",
"PackageDescription": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (31722-033-90) ",
"NDC11Code": "31722-0033-90",
"ProductNDC": "31722-033",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fesoterodine Fumarate",
"NonProprietaryName": "Fesoterodine Fumarate",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240109",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204792",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "FESOTERODINE FUMARATE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240109",
"SamplePackage": "N",
"IndicationAndUsage": "Fesoterodine fumarate extended-release tablets are indicated for the treatment of: Overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. ( 1.1). Neurogenic detrusor overactivity (NDO) in pediatric patients 6 years of age and older and weighing greater than 25 kg. (1.2).",
"Description": "Fesoterodine fumarate tablet contains fesoterodine fumarate and is an extended-release tablet. Fesoterodine is rapidly de-esterified to its active metabolite (R)-2-(3-diisopropylamino-1-phenylpropyl)-4-hydroxymethyl-phenol, or 5-hydroxymethyl tolterodine, which is a muscarinic receptor antagonist. Chemically, fesoterodine fumarate is designated as Isobutyric acid 2-((R)-3-diisopropylammonium-1-phenylpropyl)-4-(hydroxymethyl) phenyl ester hydrogen fumarate. The empirical formula is C 30H 41NO 7and its molecular weight is 527.66. The structural formula is:. Fesoterodine fumarate is a white to off-white powder, which is freely soluble in water and soluble in methanol. Each Fesoterodine fumarate extended-release tablet contains either 4 mg or 8 mg of fesoterodine fumarate and the following inactive ingredients: citric acid monohydrate, colloidal silicon dioxide, FD&C blue#2/ indigo carmine aluminum lake, glyceryl behenate, hypromellose, lecithin, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc and titanium dioxide. The botanical source for pregelatinized starch is maize starch."
}
]
}
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<NDCList>
<NDC>
<NDCCode>22840-0033-8</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (22840-0033-8) </PackageDescription>
<NDC11Code>22840-0033-08</NDC11Code>
<ProductNDC>22840-0033</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Standardized Mite Dermatophagoides Farinae</ProprietaryName>
<NonProprietaryName>Dermatophagoides Farinae</NonProprietaryName>
<DosageFormName>CONCENTRATE</DosageFormName>
<RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19870202</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101834</ApplicationNumber>
<LabelerName>Greer Laboratories, Inc.</LabelerName>
<SubstanceName>DERMATOPHAGOIDES FARINAE</SubstanceName>
<StrengthNumber>5000</StrengthNumber>
<StrengthUnit>[AU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Antigens, Dermatophagoides [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Insect Proteins [CS], Standardized Insect Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19870202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) Extracts are allergenic extracts indicated for: : 1 skin test diagnosis of mite allergy, 2 treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis.</IndicationAndUsage>
<Description>Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL.</Description>
</NDC>
<NDC>
<NDCCode>22840-0033-6</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (22840-0033-6) </PackageDescription>
<NDC11Code>22840-0033-06</NDC11Code>
<ProductNDC>22840-0033</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Standardized Mite Dermatophagoides Farinae</ProprietaryName>
<NonProprietaryName>Dermatophagoides Farinae</NonProprietaryName>
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<StartMarketingDate>19870202</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101834</ApplicationNumber>
<LabelerName>Greer Laboratories, Inc.</LabelerName>
<SubstanceName>DERMATOPHAGOIDES FARINAE</SubstanceName>
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<StrengthUnit>[AU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Antigens, Dermatophagoides [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Insect Proteins [CS], Standardized Insect Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19870202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) Extracts are allergenic extracts indicated for: : 1 skin test diagnosis of mite allergy, 2 treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis.</IndicationAndUsage>
<Description>Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL.</Description>
</NDC>
<NDC>
<NDCCode>22840-0033-9</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (22840-0033-9) </PackageDescription>
<NDC11Code>22840-0033-09</NDC11Code>
<ProductNDC>22840-0033</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Standardized Mite Dermatophagoides Farinae</ProprietaryName>
<NonProprietaryName>Dermatophagoides Farinae</NonProprietaryName>
<DosageFormName>CONCENTRATE</DosageFormName>
<RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19870202</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101834</ApplicationNumber>
<LabelerName>Greer Laboratories, Inc.</LabelerName>
<SubstanceName>DERMATOPHAGOIDES FARINAE</SubstanceName>
<StrengthNumber>5000</StrengthNumber>
<StrengthUnit>[AU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Antigens, Dermatophagoides [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Insect Proteins [CS], Standardized Insect Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19870202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) Extracts are allergenic extracts indicated for: : 1 skin test diagnosis of mite allergy, 2 treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis.</IndicationAndUsage>
<Description>Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL.</Description>
</NDC>
<NDC>
<NDCCode>54868-0033-8</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE, PLASTIC (54868-0033-8)</PackageDescription>
<NDC11Code>54868-0033-08</NDC11Code>
<ProductNDC>54868-0033</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dicyclomine Hydrochloride</ProprietaryName>
<NonProprietaryName>Dicyclomine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19951026</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA084285</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>DICYCLOMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC],Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Dicyclomine hydrochloride tablets and capsules are indicated for the treatment of functional bowel/ irritable bowel syndrome.</IndicationAndUsage>
<Description>Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following forms. 1. Dicyclomine Hydrochloride Tablets USP, for oral administration, contain 20 mg dicyclomine hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: acacia, pregelatinized starch, anhydrous lactose, compressible sugar, dicalcium phosphate, colloidal silicon dioxide, magnesium stearate, stearic acid, and FD & C Blue #1 Aluminum Lake. 2. Dicyclomine Hydrochloride Capsules USP, for oral administration, contain 10 mg of dicyclomine hydrochloride, USP. In addition, each capsule contains the following inactive ingredients: lactose monohydrate, calcium sulfate, magnesium stearate; and the capsules shells contain: gelatin, FD&C Blue # 1, and FD&C Red # 3. Chemically, dicyclomine hydrochloride is 2-(Diethylamino)ethyl [bicyclohexyl]-1-carboxylate hydrochloride with the structural formula. Dicyclomine hydrochloride occurs as a fine, white, crystalline, practically odorless powder with a bitter taste. It is soluble in water, freely soluble in alcohol and chloroform, and very slightly soluble in ether.</Description>
</NDC>
<NDC>
<NDCCode>58118-0033-8</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (58118-0033-8) </PackageDescription>
<NDC11Code>58118-0033-08</NDC11Code>
<ProductNDC>58118-0033</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Warfarin Sodium</ProprietaryName>
<NonProprietaryName>Warfarin Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150316</StartMarketingDate>
<EndMarketingDate>20181201</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040616</ApplicationNumber>
<LabelerName>Clinical Solutions Wholesale, LLC</LabelerName>
<SubstanceName>WARFARIN SODIUM</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150916</StartMarketingDatePackage>
<EndMarketingDatePackage>20181201</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>60505-0033-8</NDCCode>
<PackageDescription>5500 TABLET, EXTENDED RELEASE in 1 BOTTLE (60505-0033-8) </PackageDescription>
<NDC11Code>60505-0033-08</NDC11Code>
<ProductNDC>60505-0033</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pentoxifylline</ProprietaryName>
<NonProprietaryName>Pentoxifylline</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19990610</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075191</ApplicationNumber>
<LabelerName>Apotex Corp.</LabelerName>
<SubstanceName>PENTOXIFYLLINE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Blood Viscosity Reducer [EPC], Hematologic Activity Alteration [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-05-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19990610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>65517-0033-3</NDCCode>
<PackageDescription>500 POUCH in 1 CASE (65517-0033-3) / 3 APPLICATOR in 1 POUCH / 1.8 mL in 1 APPLICATOR</PackageDescription>
<NDC11Code>65517-0033-03</NDC11Code>
<ProductNDC>65517-0033</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pvp-iodine Swabstick Threes</ProprietaryName>
<NonProprietaryName>Povidone-iodine</NonProprietaryName>
<DosageFormName>SWAB</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180131</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Dukal LLC</LabelerName>
<SubstanceName>POVIDONE-IODINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For preparation prior to surgery. Helps to reduce bacteria that can potentially cause skin infection.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>67835-0033-8</NDCCode>
<PackageDescription>1 BAG in 1 BAG (67835-0033-8) / .1 kg in 1 BAG</PackageDescription>
<NDC11Code>67835-0033-08</NDC11Code>
<ProductNDC>67835-0033</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Dexibuprofen</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20240612</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>SMS Pharmaceuticals Limited</LabelerName>
<SubstanceName>DEXIBUPROFEN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-06-14</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>12-JUN-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>22840-0034-8</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (22840-0034-8) </PackageDescription>
<NDC11Code>22840-0034-08</NDC11Code>
<ProductNDC>22840-0034</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Standardized Mite Dermatophagoides Farinae</ProprietaryName>
<NonProprietaryName>Dermatophagoides Farinae</NonProprietaryName>
<DosageFormName>CONCENTRATE</DosageFormName>
<RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19870202</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101834</ApplicationNumber>
<LabelerName>Greer Laboratories, Inc.</LabelerName>
<SubstanceName>DERMATOPHAGOIDES FARINAE</SubstanceName>
<StrengthNumber>10000</StrengthNumber>
<StrengthUnit>[AU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Antigens, Dermatophagoides [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Insect Proteins [CS], Standardized Insect Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19870202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) Extracts are allergenic extracts indicated for: : 1 skin test diagnosis of mite allergy, 2 treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis.</IndicationAndUsage>
<Description>Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL.</Description>
</NDC>
<NDC>
<NDCCode>22840-0035-8</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (22840-0035-8) </PackageDescription>
<NDC11Code>22840-0035-08</NDC11Code>
<ProductNDC>22840-0035</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Standardized Mite Dermatophagoides Pteronyssinus</ProprietaryName>
<NonProprietaryName>Dermatophagoides Pteronyssinus</NonProprietaryName>
<DosageFormName>CONCENTRATE</DosageFormName>
<RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19890627</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101835</ApplicationNumber>
<LabelerName>Greer Laboratories, Inc.</LabelerName>
<SubstanceName>DERMATOPHAGOIDES PTERONYSSINUS</SubstanceName>
<StrengthNumber>5000</StrengthNumber>
<StrengthUnit>[AU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Antigens, Dermatophagoides [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Insect Proteins [CS], Standardized Insect Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19890627</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) Extracts are allergenic extracts indicated for: : 1 skin test diagnosis of mite allergy, 2 treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis.</IndicationAndUsage>
<Description>Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL.</Description>
</NDC>
<NDC>
<NDCCode>22840-0036-8</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (22840-0036-8) </PackageDescription>
<NDC11Code>22840-0036-08</NDC11Code>
<ProductNDC>22840-0036</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Standardized Mite Dermatophagoides Pteronyssinus</ProprietaryName>
<NonProprietaryName>Dermatophagoides Pteronyssinus</NonProprietaryName>
<DosageFormName>CONCENTRATE</DosageFormName>
<RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19890627</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101835</ApplicationNumber>
<LabelerName>Greer Laboratories, Inc.</LabelerName>
<SubstanceName>DERMATOPHAGOIDES PTERONYSSINUS</SubstanceName>
<StrengthNumber>10000</StrengthNumber>
<StrengthUnit>[AU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Antigens, Dermatophagoides [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Insect Proteins [CS], Standardized Insect Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19890627</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) Extracts are allergenic extracts indicated for: : 1 skin test diagnosis of mite allergy, 2 treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis.</IndicationAndUsage>
<Description>Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL.</Description>
</NDC>
<NDC>
<NDCCode>22840-0037-8</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (22840-0037-8) </PackageDescription>
<NDC11Code>22840-0037-08</NDC11Code>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Standardized Mite Mix Dermatophagoides Farinae And Dermatophagoides Pteronyssinus</ProprietaryName>
<NonProprietaryName>Dermatophagoides Farinae And Dermatophagoides Pteronyssinus</NonProprietaryName>
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<RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20100203</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101834</ApplicationNumber>
<LabelerName>Greer Laboratories, Inc.</LabelerName>
<SubstanceName>DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS</SubstanceName>
<StrengthNumber>5000; 5000</StrengthNumber>
<StrengthUnit>[AU]/mL; [AU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Antigens, Dermatophagoides [CS], Antigens, Dermatophagoides [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Insect Proteins [CS], Insect Proteins [CS], Standardized Insect Allergenic Extract [EPC], Standardized Insect Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) Extracts are allergenic extracts indicated for: : 1 skin test diagnosis of mite allergy, 2 treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis.</IndicationAndUsage>
<Description>Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL.</Description>
</NDC>
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<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (22840-0038-8) </PackageDescription>
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<RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20100203</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
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<LabelerName>Greer Laboratories, Inc.</LabelerName>
<SubstanceName>DERMATOPHAGOIDES FARINAE</SubstanceName>
<StrengthNumber>30000</StrengthNumber>
<StrengthUnit>[AU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Antigens, Dermatophagoides [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Insect Proteins [CS], Standardized Insect Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) Extracts are allergenic extracts indicated for: : 1 skin test diagnosis of mite allergy, 2 treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis.</IndicationAndUsage>
<Description>Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL.</Description>
</NDC>
<NDC>
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<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (22840-0039-8) </PackageDescription>
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<ProductNDC>22840-0039</ProductNDC>
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<ProprietaryName>Standardized Mite Dermatophagoides Pteronyssinus</ProprietaryName>
<NonProprietaryName>Dermatophagoides Pteronyssinus</NonProprietaryName>
<DosageFormName>CONCENTRATE</DosageFormName>
<RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20100203</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101835</ApplicationNumber>
<LabelerName>Greer Laboratories, Inc.</LabelerName>
<SubstanceName>DERMATOPHAGOIDES PTERONYSSINUS</SubstanceName>
<StrengthNumber>30000</StrengthNumber>
<StrengthUnit>[AU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Antigens, Dermatophagoides [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Insect Proteins [CS], Standardized Insect Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) Extracts are allergenic extracts indicated for: : 1 skin test diagnosis of mite allergy, 2 treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis.</IndicationAndUsage>
<Description>Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL.</Description>
</NDC>
<NDC>
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<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (22840-0040-8) </PackageDescription>
<NDC11Code>22840-0040-08</NDC11Code>
<ProductNDC>22840-0040</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Standardized Mite Mix Dermatophagoides Farinae And Dermatophagoides Pteronyssinus</ProprietaryName>
<NonProprietaryName>Dermatophagoides Farinae And Dermatophagoides Pteronyssinus</NonProprietaryName>
<DosageFormName>CONCENTRATE</DosageFormName>
<RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20100203</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101834</ApplicationNumber>
<LabelerName>Greer Laboratories, Inc.</LabelerName>
<SubstanceName>DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS</SubstanceName>
<StrengthNumber>15000; 15000</StrengthNumber>
<StrengthUnit>[AU]/mL; [AU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Antigens, Dermatophagoides [CS], Antigens, Dermatophagoides [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Insect Proteins [CS], Insect Proteins [CS], Standardized Insect Allergenic Extract [EPC], Standardized Insect Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) Extracts are allergenic extracts indicated for: : 1 skin test diagnosis of mite allergy, 2 treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis.</IndicationAndUsage>
<Description>Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus) extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. Each vial contains 5,000, 10,0000 or 30,000 Allergy Units/mL of sterile mite extract ( D. farinae and/or D. pteronyssinus), 50% glycerin v/v, and 0.4% phenol (preservative). Inert ingredients include 0.50% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. For immunotherapy, concentrated extracts are diluted in normal saline, buffered saline, albumin saline or 10% glycerosaline based on patient's reactivity. For intradermal testing, extracts may be diluted in normal saline, buffered saline, or albumin saline. Source materials for the extract are whole mite bodies. The mites are cultured, handled, and cleaned to remove at least 99% of the food medium. The medium containes no material of human origin. The mite extract is standardized by comparison to a reference preparation supplied by the Center for Biologics Evaluation and Research of the FDA, labeled 10,000 Allergy Units/mL. The relative potency of the extract is determined by ELISA inhibition compared to the FDA mite reference, and is labeled in Allergy Units/mL.</Description>
</NDC>
<NDC>
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<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (0085-1328-01) / 105 mL in 1 BOTTLE, GLASS</PackageDescription>
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<ProductNDC>0085-1328</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Noxafil</ProprietaryName>
<NonProprietaryName>Posaconazole</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060915</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022003</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>POSACONAZOLE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Noxafil is an azole antifungal indicated as follows: 1 Noxafil is indicated for the treatment of invasive aspergillosis as follows: (1.1) Noxafil injection: adults and pediatric patients 2 years of age and older who weigh 10 kg or greaterNoxafil delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kgNoxafil PowderMix for delayed-release oral suspension: pediatric patients 2 years of age and older who weigh 10 kg to 40 kg, 2 Noxafil is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy as follows: (1.2) Noxafil injection: adults and pediatric patients 2 years of age and older who weigh 10 kg or greater.Noxafil delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kgNoxafil oral suspension: adults and pediatric patients 13 years of age and olderNoxafil PowderMix for delayed-release oral suspension: pediatric patients 2 years of age and older who weigh 10 kg to 40 kg.</IndicationAndUsage>
<Description>Noxafil and Noxafil PowderMix contain posaconazole, an azole antifungal agent. Posaconazole is designated chemically as 4-[4-[4-[4-[[ (3R,5R)-5- (2,4-difluorophenyl)tetrahydro-5- (1H-1,2,4-triazol-1-ylmethyl)-3-furanyl]methoxy]phenyl]-1-piperazinyl]phenyl]-2-[(1S,2S)-1-ethyl-2-hydroxypropyl]-2,4-dihydro-3H-1,2,4-triazol-3-one with an empirical formula of C37H42F2N8O4 and a molecular weight of 700.8. The chemical structure is. Posaconazole is a white powder with a low aqueous solubility. Noxafil (posaconazole) Injection. Noxafil injection, for intravenous use, is a clear colorless to yellow, without preservatives sterile liquid essentially free of foreign matter. Each vial contains 300 mg of posaconazole and the following inactive ingredients: 6.68 g Betadex Sulfobutyl Ether Sodium (SBECD), 0.0033 g edetate disodium, hydrochloric acid and sodium hydroxide to adjust the pH to 2.6, and water for injection. Noxafil (posaconazole) Delayed-Release Tablets. Noxafil delayed-release tablet, for oral use, is yellow, coated, and oblong and contains 100 mg of posaconazole. Each delayed-release tablet contains the following inactive ingredients: croscarmellose sodium, hydroxypropylcellulose, hypromellose acetate succinate, iron oxide yellow, Macrogol/PEG 3350, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol partially hydrolyzed, silicon dioxide, talc, and titanium dioxide. Noxafil (posaconazole) Oral Suspension. Noxafil oral suspension is a white, cherry-flavored immediate-release suspension that contains 40 mg of posaconazole per mL and the following inactive ingredients: artificial cherry flavor, citric acid monohydrate, glycerin, liquid glucose, polysorbate 80, purified water, simethicone, sodium benzoate, sodium citrate dihydrate, titanium dioxide, and xanthan gum. Noxafil PowderMix (posaconazole) for Delayed-Release Oral Suspension. Noxafil PowderMix for delayed-release oral suspension is supplied as a component of a kit. Each kit contains Noxafil as an off-white to yellowish powder for delayed-release oral suspension, a bottle of mixing liquid, two 3 mL (green) notched tip syringes, two 10 mL (blue) notched tip syringes, two mixing cups, and one bottle adapter for the mixing liquid bottle. : 1 Noxafil PowderMix for delayed-release oral suspension contains 300 mg of posaconazole and the following inactive ingredient: hypromellose acetate succinate., 2 The mixing liquid contains: anhydrous citric acid, antifoam Af emulsion, berry citrus sweet flavor, carboxymethylcellulose sodium, carrageenan calcium sulfate trisodium phosphate, glycerin, methylparaben, microcrystalline cellulose, potassium sorbate, propylparaben, purified water, sodium citrate, sodium phosphate monobasic monohydrate, sodium saccharin, sorbitol solution, and xanthan gum.</Description>
</NDC>
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<NDCCode>0085-2224-02</NDCCode>
<PackageDescription>8 PACKET in 1 CARTON (0085-2224-02) / 1 POWDER, FOR SUSPENSION in 1 PACKET (0085-2224-01) </PackageDescription>
<NDC11Code>00085-2224-02</NDC11Code>
<ProductNDC>0085-2224</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Noxafil</ProprietaryName>
<NonProprietaryName>Posaconazole</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210608</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA214770</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>POSACONAZOLE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210608</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Noxafil is an azole antifungal indicated as follows: 1 Noxafil is indicated for the treatment of invasive aspergillosis as follows: (1.1) Noxafil injection: adults and pediatric patients 2 years of age and older who weigh 10 kg or greaterNoxafil delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kgNoxafil PowderMix for delayed-release oral suspension: pediatric patients 2 years of age and older who weigh 10 kg to 40 kg, 2 Noxafil is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy as follows: (1.2) Noxafil injection: adults and pediatric patients 2 years of age and older who weigh 10 kg or greater.Noxafil delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kgNoxafil oral suspension: adults and pediatric patients 13 years of age and olderNoxafil PowderMix for delayed-release oral suspension: pediatric patients 2 years of age and older who weigh 10 kg to 40 kg.</IndicationAndUsage>
<Description>Noxafil and Noxafil PowderMix contain posaconazole, an azole antifungal agent. Posaconazole is designated chemically as 4-[4-[4-[4-[[ (3R,5R)-5- (2,4-difluorophenyl)tetrahydro-5- (1H-1,2,4-triazol-1-ylmethyl)-3-furanyl]methoxy]phenyl]-1-piperazinyl]phenyl]-2-[(1S,2S)-1-ethyl-2-hydroxypropyl]-2,4-dihydro-3H-1,2,4-triazol-3-one with an empirical formula of C37H42F2N8O4 and a molecular weight of 700.8. The chemical structure is. Posaconazole is a white powder with a low aqueous solubility. Noxafil (posaconazole) Injection. Noxafil injection, for intravenous use, is a clear colorless to yellow, without preservatives sterile liquid essentially free of foreign matter. Each vial contains 300 mg of posaconazole and the following inactive ingredients: 6.68 g Betadex Sulfobutyl Ether Sodium (SBECD), 0.0033 g edetate disodium, hydrochloric acid and sodium hydroxide to adjust the pH to 2.6, and water for injection. Noxafil (posaconazole) Delayed-Release Tablets. Noxafil delayed-release tablet, for oral use, is yellow, coated, and oblong and contains 100 mg of posaconazole. Each delayed-release tablet contains the following inactive ingredients: croscarmellose sodium, hydroxypropylcellulose, hypromellose acetate succinate, iron oxide yellow, Macrogol/PEG 3350, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol partially hydrolyzed, silicon dioxide, talc, and titanium dioxide. Noxafil (posaconazole) Oral Suspension. Noxafil oral suspension is a white, cherry-flavored immediate-release suspension that contains 40 mg of posaconazole per mL and the following inactive ingredients: artificial cherry flavor, citric acid monohydrate, glycerin, liquid glucose, polysorbate 80, purified water, simethicone, sodium benzoate, sodium citrate dihydrate, titanium dioxide, and xanthan gum. Noxafil PowderMix (posaconazole) for Delayed-Release Oral Suspension. Noxafil PowderMix for delayed-release oral suspension is supplied as a component of a kit. Each kit contains Noxafil as an off-white to yellowish powder for delayed-release oral suspension, a bottle of mixing liquid, two 3 mL (green) notched tip syringes, two 10 mL (blue) notched tip syringes, two mixing cups, and one bottle adapter for the mixing liquid bottle. : 1 Noxafil PowderMix for delayed-release oral suspension contains 300 mg of posaconazole and the following inactive ingredient: hypromellose acetate succinate., 2 The mixing liquid contains: anhydrous citric acid, antifoam Af emulsion, berry citrus sweet flavor, carboxymethylcellulose sodium, carrageenan calcium sulfate trisodium phosphate, glycerin, methylparaben, microcrystalline cellulose, potassium sorbate, propylparaben, purified water, sodium citrate, sodium phosphate monobasic monohydrate, sodium saccharin, sorbitol solution, and xanthan gum.</Description>
</NDC>
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<ProductNDC>0085-4324</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<NonProprietaryName>Posaconazole</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131125</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205053</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>POSACONAZOLE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131125</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Noxafil is an azole antifungal indicated as follows: 1 Noxafil is indicated for the treatment of invasive aspergillosis as follows: (1.1) Noxafil injection: adults and pediatric patients 2 years of age and older who weigh 10 kg or greaterNoxafil delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kgNoxafil PowderMix for delayed-release oral suspension: pediatric patients 2 years of age and older who weigh 10 kg to 40 kg, 2 Noxafil is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy as follows: (1.2) Noxafil injection: adults and pediatric patients 2 years of age and older who weigh 10 kg or greater.Noxafil delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kgNoxafil oral suspension: adults and pediatric patients 13 years of age and olderNoxafil PowderMix for delayed-release oral suspension: pediatric patients 2 years of age and older who weigh 10 kg to 40 kg.</IndicationAndUsage>
<Description>Noxafil and Noxafil PowderMix contain posaconazole, an azole antifungal agent. Posaconazole is designated chemically as 4-[4-[4-[4-[[ (3R,5R)-5- (2,4-difluorophenyl)tetrahydro-5- (1H-1,2,4-triazol-1-ylmethyl)-3-furanyl]methoxy]phenyl]-1-piperazinyl]phenyl]-2-[(1S,2S)-1-ethyl-2-hydroxypropyl]-2,4-dihydro-3H-1,2,4-triazol-3-one with an empirical formula of C37H42F2N8O4 and a molecular weight of 700.8. The chemical structure is. Posaconazole is a white powder with a low aqueous solubility. Noxafil (posaconazole) Injection. Noxafil injection, for intravenous use, is a clear colorless to yellow, without preservatives sterile liquid essentially free of foreign matter. Each vial contains 300 mg of posaconazole and the following inactive ingredients: 6.68 g Betadex Sulfobutyl Ether Sodium (SBECD), 0.0033 g edetate disodium, hydrochloric acid and sodium hydroxide to adjust the pH to 2.6, and water for injection. Noxafil (posaconazole) Delayed-Release Tablets. Noxafil delayed-release tablet, for oral use, is yellow, coated, and oblong and contains 100 mg of posaconazole. Each delayed-release tablet contains the following inactive ingredients: croscarmellose sodium, hydroxypropylcellulose, hypromellose acetate succinate, iron oxide yellow, Macrogol/PEG 3350, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol partially hydrolyzed, silicon dioxide, talc, and titanium dioxide. Noxafil (posaconazole) Oral Suspension. Noxafil oral suspension is a white, cherry-flavored immediate-release suspension that contains 40 mg of posaconazole per mL and the following inactive ingredients: artificial cherry flavor, citric acid monohydrate, glycerin, liquid glucose, polysorbate 80, purified water, simethicone, sodium benzoate, sodium citrate dihydrate, titanium dioxide, and xanthan gum. Noxafil PowderMix (posaconazole) for Delayed-Release Oral Suspension. Noxafil PowderMix for delayed-release oral suspension is supplied as a component of a kit. Each kit contains Noxafil as an off-white to yellowish powder for delayed-release oral suspension, a bottle of mixing liquid, two 3 mL (green) notched tip syringes, two 10 mL (blue) notched tip syringes, two mixing cups, and one bottle adapter for the mixing liquid bottle. : 1 Noxafil PowderMix for delayed-release oral suspension contains 300 mg of posaconazole and the following inactive ingredient: hypromellose acetate succinate., 2 The mixing liquid contains: anhydrous citric acid, antifoam Af emulsion, berry citrus sweet flavor, carboxymethylcellulose sodium, carrageenan calcium sulfate trisodium phosphate, glycerin, methylparaben, microcrystalline cellulose, potassium sorbate, propylparaben, purified water, sodium citrate, sodium phosphate monobasic monohydrate, sodium saccharin, sorbitol solution, and xanthan gum.</Description>
</NDC>
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<NDCCode>0085-4331-01</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (0085-4331-01) / 16.7 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>00085-4331-01</NDC11Code>
<ProductNDC>0085-4331</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Noxafil</ProprietaryName>
<NonProprietaryName>Posaconazole</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20140313</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205596</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>POSACONAZOLE</SubstanceName>
<StrengthNumber>18</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140313</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Noxafil is an azole antifungal indicated as follows: 1 Noxafil is indicated for the treatment of invasive aspergillosis as follows: (1.1) Noxafil injection: adults and pediatric patients 2 years of age and older who weigh 10 kg or greaterNoxafil delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kgNoxafil PowderMix for delayed-release oral suspension: pediatric patients 2 years of age and older who weigh 10 kg to 40 kg, 2 Noxafil is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy as follows: (1.2) Noxafil injection: adults and pediatric patients 2 years of age and older who weigh 10 kg or greater.Noxafil delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kgNoxafil oral suspension: adults and pediatric patients 13 years of age and olderNoxafil PowderMix for delayed-release oral suspension: pediatric patients 2 years of age and older who weigh 10 kg to 40 kg.</IndicationAndUsage>
<Description>Noxafil and Noxafil PowderMix contain posaconazole, an azole antifungal agent. Posaconazole is designated chemically as 4-[4-[4-[4-[[ (3R,5R)-5- (2,4-difluorophenyl)tetrahydro-5- (1H-1,2,4-triazol-1-ylmethyl)-3-furanyl]methoxy]phenyl]-1-piperazinyl]phenyl]-2-[(1S,2S)-1-ethyl-2-hydroxypropyl]-2,4-dihydro-3H-1,2,4-triazol-3-one with an empirical formula of C37H42F2N8O4 and a molecular weight of 700.8. The chemical structure is. Posaconazole is a white powder with a low aqueous solubility. Noxafil (posaconazole) Injection. Noxafil injection, for intravenous use, is a clear colorless to yellow, without preservatives sterile liquid essentially free of foreign matter. Each vial contains 300 mg of posaconazole and the following inactive ingredients: 6.68 g Betadex Sulfobutyl Ether Sodium (SBECD), 0.0033 g edetate disodium, hydrochloric acid and sodium hydroxide to adjust the pH to 2.6, and water for injection. Noxafil (posaconazole) Delayed-Release Tablets. Noxafil delayed-release tablet, for oral use, is yellow, coated, and oblong and contains 100 mg of posaconazole. Each delayed-release tablet contains the following inactive ingredients: croscarmellose sodium, hydroxypropylcellulose, hypromellose acetate succinate, iron oxide yellow, Macrogol/PEG 3350, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol partially hydrolyzed, silicon dioxide, talc, and titanium dioxide. Noxafil (posaconazole) Oral Suspension. Noxafil oral suspension is a white, cherry-flavored immediate-release suspension that contains 40 mg of posaconazole per mL and the following inactive ingredients: artificial cherry flavor, citric acid monohydrate, glycerin, liquid glucose, polysorbate 80, purified water, simethicone, sodium benzoate, sodium citrate dihydrate, titanium dioxide, and xanthan gum. Noxafil PowderMix (posaconazole) for Delayed-Release Oral Suspension. Noxafil PowderMix for delayed-release oral suspension is supplied as a component of a kit. Each kit contains Noxafil as an off-white to yellowish powder for delayed-release oral suspension, a bottle of mixing liquid, two 3 mL (green) notched tip syringes, two 10 mL (blue) notched tip syringes, two mixing cups, and one bottle adapter for the mixing liquid bottle. : 1 Noxafil PowderMix for delayed-release oral suspension contains 300 mg of posaconazole and the following inactive ingredient: hypromellose acetate succinate., 2 The mixing liquid contains: anhydrous citric acid, antifoam Af emulsion, berry citrus sweet flavor, carboxymethylcellulose sodium, carrageenan calcium sulfate trisodium phosphate, glycerin, methylparaben, microcrystalline cellulose, potassium sorbate, propylparaben, purified water, sodium citrate, sodium phosphate monobasic monohydrate, sodium saccharin, sorbitol solution, and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>11822-0033-1</NDCCode>
<PackageDescription>80 LOZENGE in 1 BAG (11822-0033-1) </PackageDescription>
<NDC11Code>11822-0033-01</NDC11Code>
<ProductNDC>11822-0033</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cherry Cough Drop</ProprietaryName>
<NonProprietaryName>Menthol</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150424</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Rite Aid</LabelerName>
<SubstanceName>MENTHOL</SubstanceName>
<StrengthNumber>5.8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150424</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses temporarily relieves. cough as may occur with a cold. occasional minor irritation and sore throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>12022-033-00</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (12022-033-00) / 74 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>12022-0033-00</NDC11Code>
<ProductNDC>12022-033</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sulfur 8 Scalp Therapy Medicated Dandruff Control Leave-in Soothing Treatment</ProprietaryName>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M032</ApplicationNumber>
<LabelerName>J. Strickland and Co.</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for relief of scalp itching, irritation, redness, scaling and flaking associated with dandruff, seborrheic dermatitis, psoriasis.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>21695-033-12</NDCCode>
<PackageDescription>12 CAPSULE in 1 BOTTLE (21695-033-12)</PackageDescription>
<NDC11Code>21695-0033-12</NDC11Code>
<ProductNDC>21695-033</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindamycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Clindamycin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065061</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>CLINDAMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules and other antibacterial drugs, clindamycin hydrochloride capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the WARNING box, before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin.</IndicationAndUsage>
<Description>Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside monohydrochloride. The structural formula is represented below. C18H33ClN2O5SHCl M.W. 461.45. Clindamycin hydrochloride capsules, USP for oral administration contain clindamycin hydrochloride equivalent to 150 mg or 300 mg of clindamycin. Inactive ingredients: 150 mg - black iron oxide, corn starch, D&C yellow #10, FD&C blue no. 1, gelatin, lactose monohydrate, magnesium stearate, talc and titanium dioxide; 300 mg - black iron oxide, corn starch, FD&C blue no. 1, gelatin, lactose monohydrate, magnesium stearate, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>21695-033-21</NDCCode>
<PackageDescription>21 CAPSULE in 1 BOTTLE (21695-033-21)</PackageDescription>
<NDC11Code>21695-0033-21</NDC11Code>
<ProductNDC>21695-033</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindamycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Clindamycin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065061</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>CLINDAMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules and other antibacterial drugs, clindamycin hydrochloride capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the WARNING box, before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin.</IndicationAndUsage>
<Description>Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside monohydrochloride. The structural formula is represented below. C18H33ClN2O5SHCl M.W. 461.45. Clindamycin hydrochloride capsules, USP for oral administration contain clindamycin hydrochloride equivalent to 150 mg or 300 mg of clindamycin. Inactive ingredients: 150 mg - black iron oxide, corn starch, D&C yellow #10, FD&C blue no. 1, gelatin, lactose monohydrate, magnesium stearate, talc and titanium dioxide; 300 mg - black iron oxide, corn starch, FD&C blue no. 1, gelatin, lactose monohydrate, magnesium stearate, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>21695-033-28</NDCCode>
<PackageDescription>28 CAPSULE in 1 BOTTLE (21695-033-28)</PackageDescription>
<NDC11Code>21695-0033-28</NDC11Code>
<ProductNDC>21695-033</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindamycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Clindamycin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065061</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>CLINDAMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules and other antibacterial drugs, clindamycin hydrochloride capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the WARNING box, before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin.</IndicationAndUsage>
<Description>Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside monohydrochloride. The structural formula is represented below. C18H33ClN2O5SHCl M.W. 461.45. Clindamycin hydrochloride capsules, USP for oral administration contain clindamycin hydrochloride equivalent to 150 mg or 300 mg of clindamycin. Inactive ingredients: 150 mg - black iron oxide, corn starch, D&C yellow #10, FD&C blue no. 1, gelatin, lactose monohydrate, magnesium stearate, talc and titanium dioxide; 300 mg - black iron oxide, corn starch, FD&C blue no. 1, gelatin, lactose monohydrate, magnesium stearate, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>21695-033-40</NDCCode>
<PackageDescription>40 CAPSULE in 1 BOTTLE (21695-033-40)</PackageDescription>
<NDC11Code>21695-0033-40</NDC11Code>
<ProductNDC>21695-033</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindamycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Clindamycin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065061</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>CLINDAMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules and other antibacterial drugs, clindamycin hydrochloride capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the WARNING box, before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin.</IndicationAndUsage>
<Description>Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside monohydrochloride. The structural formula is represented below. C18H33ClN2O5SHCl M.W. 461.45. Clindamycin hydrochloride capsules, USP for oral administration contain clindamycin hydrochloride equivalent to 150 mg or 300 mg of clindamycin. Inactive ingredients: 150 mg - black iron oxide, corn starch, D&C yellow #10, FD&C blue no. 1, gelatin, lactose monohydrate, magnesium stearate, talc and titanium dioxide; 300 mg - black iron oxide, corn starch, FD&C blue no. 1, gelatin, lactose monohydrate, magnesium stearate, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>21695-033-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (21695-033-60)</PackageDescription>
<NDC11Code>21695-0033-60</NDC11Code>
<ProductNDC>21695-033</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindamycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Clindamycin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065061</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>CLINDAMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules and other antibacterial drugs, clindamycin hydrochloride capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the WARNING box, before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin.</IndicationAndUsage>
<Description>Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside monohydrochloride. The structural formula is represented below. C18H33ClN2O5SHCl M.W. 461.45. Clindamycin hydrochloride capsules, USP for oral administration contain clindamycin hydrochloride equivalent to 150 mg or 300 mg of clindamycin. Inactive ingredients: 150 mg - black iron oxide, corn starch, D&C yellow #10, FD&C blue no. 1, gelatin, lactose monohydrate, magnesium stearate, talc and titanium dioxide; 300 mg - black iron oxide, corn starch, FD&C blue no. 1, gelatin, lactose monohydrate, magnesium stearate, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>21695-033-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (21695-033-90)</PackageDescription>
<NDC11Code>21695-0033-90</NDC11Code>
<ProductNDC>21695-033</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindamycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Clindamycin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065061</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>CLINDAMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules and other antibacterial drugs, clindamycin hydrochloride capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the WARNING box, before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin.</IndicationAndUsage>
<Description>Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside monohydrochloride. The structural formula is represented below. C18H33ClN2O5SHCl M.W. 461.45. Clindamycin hydrochloride capsules, USP for oral administration contain clindamycin hydrochloride equivalent to 150 mg or 300 mg of clindamycin. Inactive ingredients: 150 mg - black iron oxide, corn starch, D&C yellow #10, FD&C blue no. 1, gelatin, lactose monohydrate, magnesium stearate, talc and titanium dioxide; 300 mg - black iron oxide, corn starch, FD&C blue no. 1, gelatin, lactose monohydrate, magnesium stearate, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>23359-033-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (23359-033-16)</PackageDescription>
<NDC11Code>23359-0033-16</NDC11Code>
<ProductNDC>23359-033</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ninjacof-a</ProprietaryName>
<NonProprietaryName>Ninjacof-a</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141015</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Centurion Labs, LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; CHLOPHEDIANOL HYDROCHLORIDE; PYRILAMINE MALEATE</SubstanceName>
<StrengthNumber>160; 12.5; 12.5</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: : 1 cough due to minor throat and bronchial irritation, 2 calms the cough control center and relieves coughing, 3 itching of the nose or throat, 4 itchy, watery eyes, 5 minor aches and pains, 6 temporarily reduces fever, 7 runny nose, 8 sneezing, 9 headache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>31722-033-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (31722-033-30) </PackageDescription>
<NDC11Code>31722-0033-30</NDC11Code>
<ProductNDC>31722-033</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fesoterodine Fumarate</ProprietaryName>
<NonProprietaryName>Fesoterodine Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240109</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204792</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>FESOTERODINE FUMARATE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240109</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fesoterodine fumarate extended-release tablets are indicated for the treatment of: Overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. ( 1.1). Neurogenic detrusor overactivity (NDO) in pediatric patients 6 years of age and older and weighing greater than 25 kg. (1.2).</IndicationAndUsage>
<Description>Fesoterodine fumarate tablet contains fesoterodine fumarate and is an extended-release tablet. Fesoterodine is rapidly de-esterified to its active metabolite (R)-2-(3-diisopropylamino-1-phenylpropyl)-4-hydroxymethyl-phenol, or 5-hydroxymethyl tolterodine, which is a muscarinic receptor antagonist. Chemically, fesoterodine fumarate is designated as Isobutyric acid 2-((R)-3-diisopropylammonium-1-phenylpropyl)-4-(hydroxymethyl) phenyl ester hydrogen fumarate. The empirical formula is C 30H 41NO 7and its molecular weight is 527.66. The structural formula is:. Fesoterodine fumarate is a white to off-white powder, which is freely soluble in water and soluble in methanol. Each Fesoterodine fumarate extended-release tablet contains either 4 mg or 8 mg of fesoterodine fumarate and the following inactive ingredients: citric acid monohydrate, colloidal silicon dioxide, FD&C blue#2/ indigo carmine aluminum lake, glyceryl behenate, hypromellose, lecithin, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc and titanium dioxide. The botanical source for pregelatinized starch is maize starch.</Description>
</NDC>
<NDC>
<NDCCode>31722-033-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (31722-033-90) </PackageDescription>
<NDC11Code>31722-0033-90</NDC11Code>
<ProductNDC>31722-033</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fesoterodine Fumarate</ProprietaryName>
<NonProprietaryName>Fesoterodine Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240109</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204792</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>FESOTERODINE FUMARATE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240109</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fesoterodine fumarate extended-release tablets are indicated for the treatment of: Overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. ( 1.1). Neurogenic detrusor overactivity (NDO) in pediatric patients 6 years of age and older and weighing greater than 25 kg. (1.2).</IndicationAndUsage>
<Description>Fesoterodine fumarate tablet contains fesoterodine fumarate and is an extended-release tablet. Fesoterodine is rapidly de-esterified to its active metabolite (R)-2-(3-diisopropylamino-1-phenylpropyl)-4-hydroxymethyl-phenol, or 5-hydroxymethyl tolterodine, which is a muscarinic receptor antagonist. Chemically, fesoterodine fumarate is designated as Isobutyric acid 2-((R)-3-diisopropylammonium-1-phenylpropyl)-4-(hydroxymethyl) phenyl ester hydrogen fumarate. The empirical formula is C 30H 41NO 7and its molecular weight is 527.66. The structural formula is:. Fesoterodine fumarate is a white to off-white powder, which is freely soluble in water and soluble in methanol. Each Fesoterodine fumarate extended-release tablet contains either 4 mg or 8 mg of fesoterodine fumarate and the following inactive ingredients: citric acid monohydrate, colloidal silicon dioxide, FD&C blue#2/ indigo carmine aluminum lake, glyceryl behenate, hypromellose, lecithin, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc and titanium dioxide. The botanical source for pregelatinized starch is maize starch.</Description>
</NDC>
</NDCList>