{
"NDC": [
{
"NDCCode": "68071-1994-5",
"PackageDescription": "15 TABLET in 1 BOTTLE (68071-1994-5) ",
"NDC11Code": "68071-1994-05",
"ProductNDC": "68071-1994",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meloxicam",
"NonProprietaryName": "Meloxicam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070307",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077927",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "MELOXICAM",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180117",
"SamplePackage": "N",
"IndicationAndUsage": "Meloxicam tablets are a non-steroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) ( 1.1) , 2 Rheumatoid Arthritis (RA) ( 1.2) , 3 Juvenile Rheumatoid Arthritis (JRA) in patients who weigh ≥60 kg ( 1.3) .",
"Description": "Meloxicam Tablets USP are a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl- N-(5-methyl-2-thiazolyl)-2 H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14H 13N 3O 4S 2 and it has the following structural formula:. Meloxicam is a pastel yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P)app = 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in Meloxicam tablets USP include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium citrate dihydrate."
},
{
"NDCCode": "36987-1994-1",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (36987-1994-1)",
"NDC11Code": "36987-1994-01",
"ProductNDC": "36987-1994",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bipolaris Sorokiniana",
"NonProprietaryName": "Bipolaris Sorokiniana",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "COCHLIOBOLUS SATIVUS",
"StrengthNumber": "20000",
"StrengthUnit": "[PNU]/mL",
"Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "49817-1994-5",
"PackageDescription": "1 BOTTLE in 1 CARTON (49817-1994-5) > 33 g in 1 BOTTLE (49817-1994-9)",
"NDC11Code": "49817-1994-05",
"ProductNDC": "49817-1994",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fresh Umbrian Clay Freshface Foundation Spf 20 Sandy Lane",
"NonProprietaryName": "Octinoxate",
"DosageFormName": "EMULSION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090401",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Guerlain",
"SubstanceName": "OCTINOXATE",
"StrengthNumber": "3",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2015-11-18"
},
{
"NDCCode": "71335-1994-5",
"PackageDescription": "120 TABLET in 1 BOTTLE (71335-1994-5) ",
"NDC11Code": "71335-1994-05",
"ProductNDC": "71335-1994",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propranolol Hydrochloride",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20191031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070322",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220210",
"SamplePackage": "N",
"IndicationAndUsage": "Propranolol hydrochloride tablets, USP are indicated in the management of hypertension. They may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride tablets, USP are not indicated in the management of hypertensive emergencies.",
"Description": "Propranolol hydrochloride, USP is a synthetic beta-adrenergic receptor blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. Its structural formula is. C16H21NO2HCl M.W. 295.80. Propranolol hydrochloride, USP is a stable, white, crystalline solid which is readily soluble in water and in ethanol. Propranolol hydrochloride tablets, USP are available as tablets for oral administration containing either 10 mg, 20 mg, 40 mg, 60 mg, or 80 mg of propranolol hydrochloride, USP. Propranolol hydrochloride tablets, USP also contain colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose. Color additives include FD&C Yellow no. 6 aluminum lake (10 mg and 80 mg), D&C Yellow no. 10 aluminum lake (40 mg and 80 mg), FD&C Blue no. 1 aluminum lake (20 mg and 40 mg) and FD&C Red no. 40 aluminum lake (60 mg)."
},
{
"NDCCode": "68071-1994-2",
"PackageDescription": "20 TABLET in 1 BOTTLE (68071-1994-2) ",
"NDC11Code": "68071-1994-02",
"ProductNDC": "68071-1994",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meloxicam",
"NonProprietaryName": "Meloxicam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070307",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077927",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "MELOXICAM",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180117",
"SamplePackage": "N",
"IndicationAndUsage": "Meloxicam tablets are a non-steroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) ( 1.1) , 2 Rheumatoid Arthritis (RA) ( 1.2) , 3 Juvenile Rheumatoid Arthritis (JRA) in patients who weigh ≥60 kg ( 1.3) .",
"Description": "Meloxicam Tablets USP are a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl- N-(5-methyl-2-thiazolyl)-2 H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14H 13N 3O 4S 2 and it has the following structural formula:. Meloxicam is a pastel yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P)app = 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in Meloxicam tablets USP include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium citrate dihydrate."
},
{
"NDCCode": "68071-1994-3",
"PackageDescription": "30 TABLET in 1 BOTTLE (68071-1994-3) ",
"NDC11Code": "68071-1994-03",
"ProductNDC": "68071-1994",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meloxicam",
"NonProprietaryName": "Meloxicam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070307",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077927",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "MELOXICAM",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180117",
"SamplePackage": "N",
"IndicationAndUsage": "Meloxicam tablets are a non-steroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) ( 1.1) , 2 Rheumatoid Arthritis (RA) ( 1.2) , 3 Juvenile Rheumatoid Arthritis (JRA) in patients who weigh ≥60 kg ( 1.3) .",
"Description": "Meloxicam Tablets USP are a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl- N-(5-methyl-2-thiazolyl)-2 H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14H 13N 3O 4S 2 and it has the following structural formula:. Meloxicam is a pastel yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P)app = 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in Meloxicam tablets USP include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium citrate dihydrate."
},
{
"NDCCode": "68071-1994-6",
"PackageDescription": "60 TABLET in 1 BOTTLE (68071-1994-6) ",
"NDC11Code": "68071-1994-06",
"ProductNDC": "68071-1994",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meloxicam",
"NonProprietaryName": "Meloxicam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070307",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077927",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "MELOXICAM",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180117",
"SamplePackage": "N",
"IndicationAndUsage": "Meloxicam tablets are a non-steroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) ( 1.1) , 2 Rheumatoid Arthritis (RA) ( 1.2) , 3 Juvenile Rheumatoid Arthritis (JRA) in patients who weigh ≥60 kg ( 1.3) .",
"Description": "Meloxicam Tablets USP are a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl- N-(5-methyl-2-thiazolyl)-2 H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14H 13N 3O 4S 2 and it has the following structural formula:. Meloxicam is a pastel yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P)app = 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in Meloxicam tablets USP include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium citrate dihydrate."
},
{
"NDCCode": "68071-1994-9",
"PackageDescription": "90 TABLET in 1 BOTTLE (68071-1994-9) ",
"NDC11Code": "68071-1994-09",
"ProductNDC": "68071-1994",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meloxicam",
"NonProprietaryName": "Meloxicam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070307",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077927",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "MELOXICAM",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180117",
"SamplePackage": "N",
"IndicationAndUsage": "Meloxicam tablets are a non-steroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) ( 1.1) , 2 Rheumatoid Arthritis (RA) ( 1.2) , 3 Juvenile Rheumatoid Arthritis (JRA) in patients who weigh ≥60 kg ( 1.3) .",
"Description": "Meloxicam Tablets USP are a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl- N-(5-methyl-2-thiazolyl)-2 H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14H 13N 3O 4S 2 and it has the following structural formula:. Meloxicam is a pastel yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P)app = 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in Meloxicam tablets USP include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium citrate dihydrate."
},
{
"NDCCode": "49288-0100-2",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (49288-0100-2)",
"NDC11Code": "49288-0100-02",
"ProductNDC": "49288-0100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Coffee",
"NonProprietaryName": "Coffee",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "ARABICA COFFEE BEAN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Seed Storage Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "FOR DIAGNOSTIC USE ONLY. This product has not been shown by adequate data to be safe and effective for therapeutic use according to Federal Register Notice dated November 16, 1994, Vol. 59, No. 220. The following allergenic extracts are \"For Diagnostic Use Only\": Coffee (Coffea arabic), Cottonseed (Gossypium spp.), Flaxseed (Linum usitatissimum), Leafhopper (Cicadellidae), Miller Moth (Night Flying Lepidoptera), Cricket (Gryllidae) and Moth (Frenatae). These extracts are intended for diagnostic testing of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing.",
"Description": "Antigen Laboratories' allergenic extracts are manufactured from source material listed on the vial label. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms. All source materials are inspected by Antigen Laboratories' technical personnel in accordance with 21 CFR 680.1 (b) (I). The following \"For Diagnostic Use Only\" allergenic extracts are extracted at a 1:20 w/v or 1:50 w/v ratio of source material to extracting fluid:. The source material for Coffee is prepared by grinding the seed of the coffee plant (Coffea arabic). The source material for Cottonseed is prepared by grinding the seed of the cotton plant (Gossypium spp.). The source material for Flaxseed is prepared by grinding the seed of the flax plant (Linum usitatissimum). Leafhopper source material is pulverized whole bodies of Leafhoppers (Cicadellidae). Miller Moth source material is pulverized whole bodies of night flying moths (Lepidoptera). Cricket source material is pulverized whole bodies of crickets (Gryllidae). Moth source material is pulverized whole bodies of moths of the order Frenatae. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER:. INACTIVE INGREDIENTS. Sodium chloride……………………………………………………………………...0.95%. Sodium bicarbonate………………………………………………………………….0.24%. USP Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label."
},
{
"NDCCode": "49288-0100-5",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (49288-0100-5)",
"NDC11Code": "49288-0100-05",
"ProductNDC": "49288-0100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Coffee",
"NonProprietaryName": "Coffee",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "ARABICA COFFEE BEAN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Seed Storage Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "FOR DIAGNOSTIC USE ONLY. This product has not been shown by adequate data to be safe and effective for therapeutic use according to Federal Register Notice dated November 16, 1994, Vol. 59, No. 220. The following allergenic extracts are \"For Diagnostic Use Only\": Coffee (Coffea arabic), Cottonseed (Gossypium spp.), Flaxseed (Linum usitatissimum), Leafhopper (Cicadellidae), Miller Moth (Night Flying Lepidoptera), Cricket (Gryllidae) and Moth (Frenatae). These extracts are intended for diagnostic testing of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing.",
"Description": "Antigen Laboratories' allergenic extracts are manufactured from source material listed on the vial label. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms. All source materials are inspected by Antigen Laboratories' technical personnel in accordance with 21 CFR 680.1 (b) (I). The following \"For Diagnostic Use Only\" allergenic extracts are extracted at a 1:20 w/v or 1:50 w/v ratio of source material to extracting fluid:. The source material for Coffee is prepared by grinding the seed of the coffee plant (Coffea arabic). The source material for Cottonseed is prepared by grinding the seed of the cotton plant (Gossypium spp.). The source material for Flaxseed is prepared by grinding the seed of the flax plant (Linum usitatissimum). Leafhopper source material is pulverized whole bodies of Leafhoppers (Cicadellidae). Miller Moth source material is pulverized whole bodies of night flying moths (Lepidoptera). Cricket source material is pulverized whole bodies of crickets (Gryllidae). Moth source material is pulverized whole bodies of moths of the order Frenatae. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER:. INACTIVE INGREDIENTS. Sodium chloride……………………………………………………………………...0.95%. Sodium bicarbonate………………………………………………………………….0.24%. USP Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label."
},
{
"NDCCode": "49288-0116-2",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (49288-0116-2)",
"NDC11Code": "49288-0116-02",
"ProductNDC": "49288-0116",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cottonseed",
"NonProprietaryName": "Cottonseed",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "COTTON SEED",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Plant Proteins [CS],Seed Storage Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "FOR DIAGNOSTIC USE ONLY. This product has not been shown by adequate data to be safe and effective for therapeutic use according to Federal Register Notice dated November 16, 1994, Vol. 59, No. 220. The following allergenic extracts are \"For Diagnostic Use Only\": Coffee (Coffea arabic), Cottonseed (Gossypium spp.), Flaxseed (Linum usitatissimum), Leafhopper (Cicadellidae), Miller Moth (Night Flying Lepidoptera), Cricket (Gryllidae) and Moth (Frenatae). These extracts are intended for diagnostic testing of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing.",
"Description": "Antigen Laboratories' allergenic extracts are manufactured from source material listed on the vial label. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms. All source materials are inspected by Antigen Laboratories' technical personnel in accordance with 21 CFR 680.1 (b) (I). The following \"For Diagnostic Use Only\" allergenic extracts are extracted at a 1:20 w/v or 1:50 w/v ratio of source material to extracting fluid:. The source material for Coffee is prepared by grinding the seed of the coffee plant (Coffea arabic). The source material for Cottonseed is prepared by grinding the seed of the cotton plant (Gossypium spp.). The source material for Flaxseed is prepared by grinding the seed of the flax plant (Linum usitatissimum). Leafhopper source material is pulverized whole bodies of Leafhoppers (Cicadellidae). Miller Moth source material is pulverized whole bodies of night flying moths (Lepidoptera). Cricket source material is pulverized whole bodies of crickets (Gryllidae). Moth source material is pulverized whole bodies of moths of the order Frenatae. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER:. INACTIVE INGREDIENTS. Sodium chloride……………………………………………………………………...0.95%. Sodium bicarbonate………………………………………………………………….0.24%. USP Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label."
},
{
"NDCCode": "49288-0116-5",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (49288-0116-5)",
"NDC11Code": "49288-0116-05",
"ProductNDC": "49288-0116",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cottonseed",
"NonProprietaryName": "Cottonseed",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "COTTON SEED",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Plant Proteins [CS],Seed Storage Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "FOR DIAGNOSTIC USE ONLY. This product has not been shown by adequate data to be safe and effective for therapeutic use according to Federal Register Notice dated November 16, 1994, Vol. 59, No. 220. The following allergenic extracts are \"For Diagnostic Use Only\": Coffee (Coffea arabic), Cottonseed (Gossypium spp.), Flaxseed (Linum usitatissimum), Leafhopper (Cicadellidae), Miller Moth (Night Flying Lepidoptera), Cricket (Gryllidae) and Moth (Frenatae). These extracts are intended for diagnostic testing of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing.",
"Description": "Antigen Laboratories' allergenic extracts are manufactured from source material listed on the vial label. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms. All source materials are inspected by Antigen Laboratories' technical personnel in accordance with 21 CFR 680.1 (b) (I). The following \"For Diagnostic Use Only\" allergenic extracts are extracted at a 1:20 w/v or 1:50 w/v ratio of source material to extracting fluid:. The source material for Coffee is prepared by grinding the seed of the coffee plant (Coffea arabic). The source material for Cottonseed is prepared by grinding the seed of the cotton plant (Gossypium spp.). The source material for Flaxseed is prepared by grinding the seed of the flax plant (Linum usitatissimum). Leafhopper source material is pulverized whole bodies of Leafhoppers (Cicadellidae). Miller Moth source material is pulverized whole bodies of night flying moths (Lepidoptera). Cricket source material is pulverized whole bodies of crickets (Gryllidae). Moth source material is pulverized whole bodies of moths of the order Frenatae. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER:. INACTIVE INGREDIENTS. Sodium chloride……………………………………………………………………...0.95%. Sodium bicarbonate………………………………………………………………….0.24%. USP Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label."
},
{
"NDCCode": "49288-0160-2",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (49288-0160-2)",
"NDC11Code": "49288-0160-02",
"ProductNDC": "49288-0160",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cricket",
"NonProprietaryName": "Cricket",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "ACHETA DOMESTICUS",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "FOR DIAGNOSTIC USE ONLY. This product has not been shown by adequate data to be safe and effective for therapeutic use according to Federal Register Notice dated November 16, 1994, Vol. 59, No. 220. The following allergenic extracts are \"For Diagnostic Use Only\": Coffee (Coffea arabic), Cottonseed (Gossypium spp.), Flaxseed (Linum usitatissimum), Leafhopper (Cicadellidae), Miller Moth (Night Flying Lepidoptera), Cricket (Gryllidae) and Moth (Frenatae). These extracts are intended for diagnostic testing of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing.",
"Description": "Antigen Laboratories' allergenic extracts are manufactured from source material listed on the vial label. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms. All source materials are inspected by Antigen Laboratories' technical personnel in accordance with 21 CFR 680.1 (b) (I). The following \"For Diagnostic Use Only\" allergenic extracts are extracted at a 1:20 w/v or 1:50 w/v ratio of source material to extracting fluid:. The source material for Coffee is prepared by grinding the seed of the coffee plant (Coffea arabic). The source material for Cottonseed is prepared by grinding the seed of the cotton plant (Gossypium spp.). The source material for Flaxseed is prepared by grinding the seed of the flax plant (Linum usitatissimum). Leafhopper source material is pulverized whole bodies of Leafhoppers (Cicadellidae). Miller Moth source material is pulverized whole bodies of night flying moths (Lepidoptera). Cricket source material is pulverized whole bodies of crickets (Gryllidae). Moth source material is pulverized whole bodies of moths of the order Frenatae. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER:. INACTIVE INGREDIENTS. Sodium chloride……………………………………………………………………...0.95%. Sodium bicarbonate………………………………………………………………….0.24%. USP Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label."
},
{
"NDCCode": "49288-0160-5",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (49288-0160-5)",
"NDC11Code": "49288-0160-05",
"ProductNDC": "49288-0160",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cricket",
"NonProprietaryName": "Cricket",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "ACHETA DOMESTICUS",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "FOR DIAGNOSTIC USE ONLY. This product has not been shown by adequate data to be safe and effective for therapeutic use according to Federal Register Notice dated November 16, 1994, Vol. 59, No. 220. The following allergenic extracts are \"For Diagnostic Use Only\": Coffee (Coffea arabic), Cottonseed (Gossypium spp.), Flaxseed (Linum usitatissimum), Leafhopper (Cicadellidae), Miller Moth (Night Flying Lepidoptera), Cricket (Gryllidae) and Moth (Frenatae). These extracts are intended for diagnostic testing of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing.",
"Description": "Antigen Laboratories' allergenic extracts are manufactured from source material listed on the vial label. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms. All source materials are inspected by Antigen Laboratories' technical personnel in accordance with 21 CFR 680.1 (b) (I). The following \"For Diagnostic Use Only\" allergenic extracts are extracted at a 1:20 w/v or 1:50 w/v ratio of source material to extracting fluid:. The source material for Coffee is prepared by grinding the seed of the coffee plant (Coffea arabic). The source material for Cottonseed is prepared by grinding the seed of the cotton plant (Gossypium spp.). The source material for Flaxseed is prepared by grinding the seed of the flax plant (Linum usitatissimum). Leafhopper source material is pulverized whole bodies of Leafhoppers (Cicadellidae). Miller Moth source material is pulverized whole bodies of night flying moths (Lepidoptera). Cricket source material is pulverized whole bodies of crickets (Gryllidae). Moth source material is pulverized whole bodies of moths of the order Frenatae. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER:. INACTIVE INGREDIENTS. Sodium chloride……………………………………………………………………...0.95%. Sodium bicarbonate………………………………………………………………….0.24%. USP Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label."
},
{
"NDCCode": "49288-0201-2",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (49288-0201-2)",
"NDC11Code": "49288-0201-02",
"ProductNDC": "49288-0201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flaxseed",
"NonProprietaryName": "Flaxseed",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "FLAX SEED",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Seed Storage Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "FOR DIAGNOSTIC USE ONLY. This product has not been shown by adequate data to be safe and effective for therapeutic use according to Federal Register Notice dated November 16, 1994, Vol. 59, No. 220. The following allergenic extracts are \"For Diagnostic Use Only\": Coffee (Coffea arabic), Cottonseed (Gossypium spp.), Flaxseed (Linum usitatissimum), Leafhopper (Cicadellidae), Miller Moth (Night Flying Lepidoptera), Cricket (Gryllidae) and Moth (Frenatae). These extracts are intended for diagnostic testing of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing.",
"Description": "Antigen Laboratories' allergenic extracts are manufactured from source material listed on the vial label. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms. All source materials are inspected by Antigen Laboratories' technical personnel in accordance with 21 CFR 680.1 (b) (I). The following \"For Diagnostic Use Only\" allergenic extracts are extracted at a 1:20 w/v or 1:50 w/v ratio of source material to extracting fluid:. The source material for Coffee is prepared by grinding the seed of the coffee plant (Coffea arabic). The source material for Cottonseed is prepared by grinding the seed of the cotton plant (Gossypium spp.). The source material for Flaxseed is prepared by grinding the seed of the flax plant (Linum usitatissimum). Leafhopper source material is pulverized whole bodies of Leafhoppers (Cicadellidae). Miller Moth source material is pulverized whole bodies of night flying moths (Lepidoptera). Cricket source material is pulverized whole bodies of crickets (Gryllidae). Moth source material is pulverized whole bodies of moths of the order Frenatae. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER:. INACTIVE INGREDIENTS. Sodium chloride……………………………………………………………………...0.95%. Sodium bicarbonate………………………………………………………………….0.24%. USP Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label."
},
{
"NDCCode": "49288-0201-5",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (49288-0201-5)",
"NDC11Code": "49288-0201-05",
"ProductNDC": "49288-0201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flaxseed",
"NonProprietaryName": "Flaxseed",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "FLAX SEED",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Seed Storage Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "FOR DIAGNOSTIC USE ONLY. This product has not been shown by adequate data to be safe and effective for therapeutic use according to Federal Register Notice dated November 16, 1994, Vol. 59, No. 220. The following allergenic extracts are \"For Diagnostic Use Only\": Coffee (Coffea arabic), Cottonseed (Gossypium spp.), Flaxseed (Linum usitatissimum), Leafhopper (Cicadellidae), Miller Moth (Night Flying Lepidoptera), Cricket (Gryllidae) and Moth (Frenatae). These extracts are intended for diagnostic testing of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing.",
"Description": "Antigen Laboratories' allergenic extracts are manufactured from source material listed on the vial label. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms. All source materials are inspected by Antigen Laboratories' technical personnel in accordance with 21 CFR 680.1 (b) (I). The following \"For Diagnostic Use Only\" allergenic extracts are extracted at a 1:20 w/v or 1:50 w/v ratio of source material to extracting fluid:. The source material for Coffee is prepared by grinding the seed of the coffee plant (Coffea arabic). The source material for Cottonseed is prepared by grinding the seed of the cotton plant (Gossypium spp.). The source material for Flaxseed is prepared by grinding the seed of the flax plant (Linum usitatissimum). Leafhopper source material is pulverized whole bodies of Leafhoppers (Cicadellidae). Miller Moth source material is pulverized whole bodies of night flying moths (Lepidoptera). Cricket source material is pulverized whole bodies of crickets (Gryllidae). Moth source material is pulverized whole bodies of moths of the order Frenatae. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER:. INACTIVE INGREDIENTS. Sodium chloride……………………………………………………………………...0.95%. Sodium bicarbonate………………………………………………………………….0.24%. USP Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label."
},
{
"NDCCode": "49288-0461-2",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (49288-0461-2)",
"NDC11Code": "49288-0461-02",
"ProductNDC": "49288-0461",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Miller Moth",
"NonProprietaryName": "Miller Moth",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "SITOTROGA CEREALELLA",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "FOR DIAGNOSTIC USE ONLY. This product has not been shown by adequate data to be safe and effective for therapeutic use according to Federal Register Notice dated November 16, 1994, Vol. 59, No. 220. The following allergenic extracts are \"For Diagnostic Use Only\": Coffee (Coffea arabic), Cottonseed (Gossypium spp.), Flaxseed (Linum usitatissimum), Leafhopper (Cicadellidae), Miller Moth (Night Flying Lepidoptera), Cricket (Gryllidae) and Moth (Frenatae). These extracts are intended for diagnostic testing of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing.",
"Description": "Antigen Laboratories' allergenic extracts are manufactured from source material listed on the vial label. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms. All source materials are inspected by Antigen Laboratories' technical personnel in accordance with 21 CFR 680.1 (b) (I). The following \"For Diagnostic Use Only\" allergenic extracts are extracted at a 1:20 w/v or 1:50 w/v ratio of source material to extracting fluid:. The source material for Coffee is prepared by grinding the seed of the coffee plant (Coffea arabic). The source material for Cottonseed is prepared by grinding the seed of the cotton plant (Gossypium spp.). The source material for Flaxseed is prepared by grinding the seed of the flax plant (Linum usitatissimum). Leafhopper source material is pulverized whole bodies of Leafhoppers (Cicadellidae). Miller Moth source material is pulverized whole bodies of night flying moths (Lepidoptera). Cricket source material is pulverized whole bodies of crickets (Gryllidae). Moth source material is pulverized whole bodies of moths of the order Frenatae. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER:. INACTIVE INGREDIENTS. Sodium chloride……………………………………………………………………...0.95%. Sodium bicarbonate………………………………………………………………….0.24%. USP Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label."
},
{
"NDCCode": "49288-0461-5",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (49288-0461-5)",
"NDC11Code": "49288-0461-05",
"ProductNDC": "49288-0461",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Miller Moth",
"NonProprietaryName": "Miller Moth",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "SITOTROGA CEREALELLA",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "FOR DIAGNOSTIC USE ONLY. This product has not been shown by adequate data to be safe and effective for therapeutic use according to Federal Register Notice dated November 16, 1994, Vol. 59, No. 220. The following allergenic extracts are \"For Diagnostic Use Only\": Coffee (Coffea arabic), Cottonseed (Gossypium spp.), Flaxseed (Linum usitatissimum), Leafhopper (Cicadellidae), Miller Moth (Night Flying Lepidoptera), Cricket (Gryllidae) and Moth (Frenatae). These extracts are intended for diagnostic testing of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing.",
"Description": "Antigen Laboratories' allergenic extracts are manufactured from source material listed on the vial label. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms. All source materials are inspected by Antigen Laboratories' technical personnel in accordance with 21 CFR 680.1 (b) (I). The following \"For Diagnostic Use Only\" allergenic extracts are extracted at a 1:20 w/v or 1:50 w/v ratio of source material to extracting fluid:. The source material for Coffee is prepared by grinding the seed of the coffee plant (Coffea arabic). The source material for Cottonseed is prepared by grinding the seed of the cotton plant (Gossypium spp.). The source material for Flaxseed is prepared by grinding the seed of the flax plant (Linum usitatissimum). Leafhopper source material is pulverized whole bodies of Leafhoppers (Cicadellidae). Miller Moth source material is pulverized whole bodies of night flying moths (Lepidoptera). Cricket source material is pulverized whole bodies of crickets (Gryllidae). Moth source material is pulverized whole bodies of moths of the order Frenatae. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER:. INACTIVE INGREDIENTS. Sodium chloride……………………………………………………………………...0.95%. Sodium bicarbonate………………………………………………………………….0.24%. USP Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label."
},
{
"NDCCode": "68071-1212-5",
"PackageDescription": "14 CAPSULE in 1 BOTTLE (68071-1212-5) ",
"NDC11Code": "68071-1212-05",
"ProductNDC": "68071-1212",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160629",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090705",
"LabelerName": "NuCare Pharmaceuticals, Inc.",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170324",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin is indicated for: 1 Postherpetic neuralgia in adults ( 1) , 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy ( 1) .",
"Description": "The active ingredient in gabapentin capsules is gabapentin, USP which has the chemical name 1-(aminomethyl) cyclohexane acetic acid. The molecular formula of gabapentin is C 9H 17NO 2 and a molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin, USP is a white to off-white crystalline solid with a pK a1 of 3.7 and a pK a2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Gabapentin Capsules, USP are supplied as imprinted hard gelatin capsules containing 100 mg, 300 mg and 400 mg of gabapentin, USP. The inactive ingredients are mannitol, pre-gelatinized starch and talc. The 100 mg capsule shell contains titanium dioxide. The 300 mg capsule contains FD&C Red 40, D&C Yellow 10 and titanium dioxide. The 400 mg capsule shell contains FD&C Red 40, D&C Yellow 10 and titanium dioxide."
},
{
"NDCCode": "68071-1330-5",
"PackageDescription": "25 TABLET in 1 BOTTLE (68071-1330-5) ",
"NDC11Code": "68071-1330-05",
"ProductNDC": "68071-1330",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitroglycerin",
"NonProprietaryName": "Nitroglycerin",
"DosageFormName": "TABLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20160829",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208191",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "NITROGLYCERIN",
"StrengthNumber": ".4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170719",
"SamplePackage": "N",
"IndicationAndUsage": "Nitroglycerin sublingual tablets are indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.",
"Description": "Nitroglycerin is a stabilized sublingual compressed nitroglycerin tablet that contains 0.3 mg, 0.4 mg, or 0.6 mg nitroglycerin USP; as well as calcium stearate powder, colloidal silicon dioxide, hydrogenated vegetable oil, lactose monohydrate, and pregelatinized starch. Nitroglycerin, an organic nitrate, is a vasodilating agent. The chemical name for nitroglycerin is 1, 2, 3 propanetriol trinitrate and the chemical structure is:. Molecular weight: 227.09."
},
{
"NDCCode": "68071-1332-5",
"PackageDescription": "15 mL in 1 BOX (68071-1332-5)",
"NDC11Code": "68071-1332-05",
"ProductNDC": "68071-1332",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Proparacaine Hydrochloride",
"NonProprietaryName": "Proparacaine Hydrochloride",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19950929",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040074",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "PROPARACAINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Local Anesthesia [PE],Local Anesthetic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "68071-1333-5",
"PackageDescription": "25 g in 1 BOX (68071-1333-5) ",
"NDC11Code": "68071-1333-05",
"ProductNDC": "68071-1333",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Silver Sulfadiazine",
"NonProprietaryName": "Silver Sulfadiazine",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19851223",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018810",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "SILVER SULFADIAZINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Sulfonamide Antibacterial [EPC], Sulfonamides [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170804",
"SamplePackage": "N",
"IndicationAndUsage": "Silver sulfadiazine cream, USP 1% is a topical antimicrobial drug indicated as an adjunct for the prevention and treatment of wound sepsis in patients with second and third degree burns.",
"Description": "Silver sulfadiazine cream, USP 1% is a soft, white, water dispersible cream containing the antimicrobial agent silver sulfadiazine in micronized form for topical application. Each gram of silver sulfadiazine cream contains 10mg of micronized silver sulfadiazine. This active agent has the following structural formula:. Silver sulfadiazine cream contains 1% w/w silver sulfadiazine. The vehicle in which the active ingredient is dispersed consists of water, stearyl alcohol, white petrolatum, polyoxyl 40 stearate, propylene glycol, isopropyl myristate, and sorbitan monooleate with 0.3% methylparaben as a preservative."
},
{
"NDCCode": "68071-1395-5",
"PackageDescription": "45 CAPSULE in 1 BOTTLE (68071-1395-5) ",
"NDC11Code": "68071-1395-05",
"ProductNDC": "68071-1395",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benzonatate",
"NonProprietaryName": "Benzonatate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20181221",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206948",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "BENZONATATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]",
"Status": "Active",
"LastUpdate": "2024-07-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191004",
"SamplePackage": "N",
"IndicationAndUsage": "Benzonatate capsules, USP are indicated for the symptomatic relief of cough.",
"Description": "Benzonatate capsules, USP, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26- onaoxaoctacosan-28-ylp-(butylamino) benzoate; with a molecular weight of 603.7. Each benzonatate capsules, USP for oral administration contains 100 mg or 200 mg benzonatate, USP. In addition, each capsule contains the following inactive ingredients: D&C Yellow #10, gelatin, glycerin, lecithin, light mineral oil, propylene glycol, purified water, shellac glaze, titanium dioxide, and white edible ink."
},
{
"NDCCode": "68071-1513-5",
"PackageDescription": "3.5 g in 1 BOX (68071-1513-5) ",
"NDC11Code": "68071-1513-05",
"ProductNDC": "68071-1513",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gentak",
"NonProprietaryName": "Gentamicin Sulfate",
"DosageFormName": "OINTMENT",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20060508",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064093",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "GENTAMICIN SULFATE",
"StrengthNumber": "3",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190205",
"SamplePackage": "N",
"IndicationAndUsage": "Gentamicin sulfate ophthalmic ointment is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharonconjunctivitis: acute meibomianitis, and dacryocystitis, caused by susceptible strains of the following microorganisms: : 1 Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.",
"Description": "GENTAK ® Gentamicin sulfate is a water soluble antibiotic of the aminoglycoside group. Gentamicin sulfate ophthalmic ointment is a sterile ointment for ophthalmic use. Each gram contains gentamicin sulfate equivalent to 3 mg gentamicin in a base of white petrolatum and mineral oil, with methylparaben and propylparaben as preservatives. Gentamicin is obtained from cultures of Micromonospora purpurea. It is a mixture of the sulfate salts of gentamicin C 1 C 2, and C 1A. All three components appear to have similar antimicrobial activities. Gentamicin sulfate occurs as a white to buff powder and is soluble in water and insoluble in alcohol. The structural formula is as follows:."
},
{
"NDCCode": "68071-1525-5",
"PackageDescription": "200 AEROSOL, METERED in 1 BOX (68071-1525-5) ",
"NDC11Code": "68071-1525-05",
"ProductNDC": "68071-1525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Proair",
"ProprietaryNameSuffix": "Hfa",
"NonProprietaryName": "Albuterol Sulfate",
"DosageFormName": "AEROSOL, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20121203",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021457",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "ALBUTEROL SULFATE",
"StrengthNumber": "90",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20170804",
"SamplePackage": "N",
"IndicationAndUsage": "PROAIR HFA Inhalation Aerosol is a beta 2-adrenergic agonist indicated for: : 1 Treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. ( 1.1) , 2 Prevention of exercise-induced bronchospasm in patients 4 years of age and older. ( 1.2) .",
"Description": "The active ingredient of PROAIR HFA (albuterol sulfate) Inhalation Aerosol is albuterol sulfate, a racemic salt, of albuterol. Albuterol sulfate has the chemical name α 1-[( tert-butylamino) methyl]-4-hydroxy- m-xylene-α,α'-diol sulfate (2:1) (salt), and has the following chemical structure:. The molecular weight of albuterol sulfate is 576.7, and the empirical formula is (C 13H 21NO 3) 2H 2SO 4. Albuterol sulfate is a white to off-white crystalline powder. It is soluble in water and slightly soluble in ethanol. Albuterol sulfate is the official generic name in the United States, and salbutamol sulfate is the World Health Organization recommended generic name. PROAIR HFA Inhalation Aerosol is a pressurized metered-dose aerosol unit with a dose counter. PROAIR HFA is for oral inhalation only. It contains a microcrystalline suspension of albuterol sulfate in propellant HFA-134a (1, 1, 1, 2-tetrafluoroethane) and ethanol. Prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks by releasing three sprays into the air, away from the face. After priming, each actuation delivers 108 mcg albuterol sulfate, from the actuator mouthpiece (equivalent to 90 mcg of albuterol base). Each canister provides 200 actuations (inhalations). This product does not contain chlorofluorocarbons (CFCs) as the propellant."
},
{
"NDCCode": "68071-1527-5",
"PackageDescription": "15 mL in 1 BOTTLE (68071-1527-5) ",
"NDC11Code": "68071-1527-05",
"ProductNDC": "68071-1527",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin",
"NonProprietaryName": "Azithromycin",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20101228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065246",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "AZITHROMYCIN MONOHYDRATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Macrolide Antimicrobial [EPC], Macrolides [CS]",
"Status": "Active",
"LastUpdate": "2024-07-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170718",
"SamplePackage": "N",
"IndicationAndUsage": "Azithromycin for oral suspension is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications [see Dosage and Administration (2)].",
"Description": "Azithromycin for oral suspension USP contains the active ingredient azithromycin, USP, a macrolide antibacterial drug, for oral administration. Azithromycin, USP has the chemical name (2 R,3 S,4 R,5 R,8 R,10 R,11 R,12 S,13 S,14 R)-13-[(2,6-dideoxy-3- C-methyl-3- O-methyl-α-L- ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D- xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin, USP is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Azithromycin, USP has the following structural formula. C 38H 72N 2O 12 M.W. 749. Azithromycin, USP, as the monohydrate, is a white crystalline powder with a molecular formula of C 38H 72N 2O 12H 2O and a molecular weight of 767. Azithromycin for oral suspension USP is supplied in bottles containing azithromycin monohydrate powder equivalent to 300 mg, 600 mg, 900 mg or 1200 mg azithromycin, USP per bottle and the following inactive ingredients: ammonio methacrylate copolymer, banana flavor, cherry flavor, colloidal silicon dioxide, FD&C Red No. 40, hydroxypropyl cellulose, sucrose, tribasic sodium phosphate anhydrous, vanilla flavor, and xanthan gum. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin, USP."
},
{
"NDCCode": "68071-1528-5",
"PackageDescription": "15 mL in 1 BOTTLE (68071-1528-5) ",
"NDC11Code": "68071-1528-05",
"ProductNDC": "68071-1528",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin",
"NonProprietaryName": "Azithromycin",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20101217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065246",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "AZITHROMYCIN MONOHYDRATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Macrolide Antimicrobial [EPC], Macrolides [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170718",
"SamplePackage": "N",
"IndicationAndUsage": "Azithromycin for oral suspension is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications [see Dosage and Administration (2)].",
"Description": "Azithromycin for oral suspension USP contains the active ingredient azithromycin, USP, a macrolide antibacterial drug, for oral administration. Azithromycin, USP has the chemical name (2 R,3 S,4 R,5 R,8 R,10 R,11 R,12 S,13 S,14 R)-13-[(2,6-dideoxy-3- C-methyl-3- O-methyl-α-L- ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D- xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin, USP is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Azithromycin, USP has the following structural formula. C 38H 72N 2O 12 M.W. 749. Azithromycin, USP, as the monohydrate, is a white crystalline powder with a molecular formula of C 38H 72N 2O 12H 2O and a molecular weight of 767. Azithromycin for oral suspension USP is supplied in bottles containing azithromycin monohydrate powder equivalent to 300 mg, 600 mg, 900 mg or 1200 mg azithromycin, USP per bottle and the following inactive ingredients: ammonio methacrylate copolymer, banana flavor, cherry flavor, colloidal silicon dioxide, FD&C Red No. 40, hydroxypropyl cellulose, sucrose, tribasic sodium phosphate anhydrous, vanilla flavor, and xanthan gum. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin, USP."
},
{
"NDCCode": "68071-1530-5",
"PackageDescription": "5 mL in 1 BOX (68071-1530-5) ",
"NDC11Code": "68071-1530-05",
"ProductNDC": "68071-1530",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin Hydrochloride",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20080320",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077689",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "3.5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Quinolone Antimicrobial [EPC],Quinolones [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-04-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20170712",
"SamplePackage": "N"
},
{
"NDCCode": "68071-1538-5",
"PackageDescription": "45 g in 1 BOX (68071-1538-5) ",
"NDC11Code": "68071-1538-05",
"ProductNDC": "68071-1538",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mometasone Furoate",
"NonProprietaryName": "Mometasone Furoate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080528",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078541",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "MOMETASONE FUROATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170725",
"SamplePackage": "N",
"IndicationAndUsage": "Mometasone furoate cream USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 2 years of age or older.",
"Description": "Mometasone furoate cream USP, 0.1% contains mometasone furoate USP for topical use. Mometasone furoate USP is a synthetic corticosteroid with anti-inflammatory activity. Chemically, mometasone furoate USP is 9α,21-dichloro-11β,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-(2-furoate), with the empirical formula C 27H 30CI 2O 6, a molecular weight of 521.43 and the following structural formula:. Mometasone furoate USP is a white to off-white powder, soluble in acetone and methylene chloride. Each gram of mometasone furoate cream USP, 0.1% contains: 1 mg mometasone furoate USP in a cream base of hexylene glycol, phosphoric acid, propylene glycol stearate (55% monoester), stearyl alcohol and ceteareth-20, titanium dioxide, aluminum starch octenylsuccinate (Gamma Irradiated), white wax, white petrolatum, and purified water."
},
{
"NDCCode": "68071-1550-6",
"PackageDescription": "2.5 mL in 1 VIAL (68071-1550-6) ",
"NDC11Code": "68071-1550-06",
"ProductNDC": "68071-1550",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ipratropium Bromide",
"NonProprietaryName": "Ipratropium Bromide",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075693",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "IPRATROPIUM BROMIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/2.5mL",
"Pharm_Classes": "Anticholinergic [EPC],Cholinergic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-04-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20171227",
"SamplePackage": "N"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>68071-1994-5</NDCCode>
<PackageDescription>15 TABLET in 1 BOTTLE (68071-1994-5) </PackageDescription>
<NDC11Code>68071-1994-05</NDC11Code>
<ProductNDC>68071-1994</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meloxicam</ProprietaryName>
<NonProprietaryName>Meloxicam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070307</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077927</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>MELOXICAM</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180117</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Meloxicam tablets are a non-steroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) ( 1.1) , 2 Rheumatoid Arthritis (RA) ( 1.2) , 3 Juvenile Rheumatoid Arthritis (JRA) in patients who weigh ≥60 kg ( 1.3) .</IndicationAndUsage>
<Description>Meloxicam Tablets USP are a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl- N-(5-methyl-2-thiazolyl)-2 H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14H 13N 3O 4S 2 and it has the following structural formula:. Meloxicam is a pastel yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P)app = 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in Meloxicam tablets USP include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium citrate dihydrate.</Description>
</NDC>
<NDC>
<NDCCode>36987-1994-1</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (36987-1994-1)</PackageDescription>
<NDC11Code>36987-1994-01</NDC11Code>
<ProductNDC>36987-1994</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bipolaris Sorokiniana</ProprietaryName>
<NonProprietaryName>Bipolaris Sorokiniana</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>COCHLIOBOLUS SATIVUS</SubstanceName>
<StrengthNumber>20000</StrengthNumber>
<StrengthUnit>[PNU]/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>49817-1994-5</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (49817-1994-5) > 33 g in 1 BOTTLE (49817-1994-9)</PackageDescription>
<NDC11Code>49817-1994-05</NDC11Code>
<ProductNDC>49817-1994</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fresh Umbrian Clay Freshface Foundation Spf 20 Sandy Lane</ProprietaryName>
<NonProprietaryName>Octinoxate</NonProprietaryName>
<DosageFormName>EMULSION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20090401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Guerlain</LabelerName>
<SubstanceName>OCTINOXATE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-11-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>71335-1994-5</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE (71335-1994-5) </PackageDescription>
<NDC11Code>71335-1994-05</NDC11Code>
<ProductNDC>71335-1994</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191031</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070322</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propranolol hydrochloride tablets, USP are indicated in the management of hypertension. They may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride tablets, USP are not indicated in the management of hypertensive emergencies.</IndicationAndUsage>
<Description>Propranolol hydrochloride, USP is a synthetic beta-adrenergic receptor blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. Its structural formula is. C16H21NO2HCl M.W. 295.80. Propranolol hydrochloride, USP is a stable, white, crystalline solid which is readily soluble in water and in ethanol. Propranolol hydrochloride tablets, USP are available as tablets for oral administration containing either 10 mg, 20 mg, 40 mg, 60 mg, or 80 mg of propranolol hydrochloride, USP. Propranolol hydrochloride tablets, USP also contain colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose. Color additives include FD&C Yellow no. 6 aluminum lake (10 mg and 80 mg), D&C Yellow no. 10 aluminum lake (40 mg and 80 mg), FD&C Blue no. 1 aluminum lake (20 mg and 40 mg) and FD&C Red no. 40 aluminum lake (60 mg).</Description>
</NDC>
<NDC>
<NDCCode>68071-1994-2</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE (68071-1994-2) </PackageDescription>
<NDC11Code>68071-1994-02</NDC11Code>
<ProductNDC>68071-1994</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meloxicam</ProprietaryName>
<NonProprietaryName>Meloxicam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070307</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077927</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>MELOXICAM</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180117</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Meloxicam tablets are a non-steroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) ( 1.1) , 2 Rheumatoid Arthritis (RA) ( 1.2) , 3 Juvenile Rheumatoid Arthritis (JRA) in patients who weigh ≥60 kg ( 1.3) .</IndicationAndUsage>
<Description>Meloxicam Tablets USP are a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl- N-(5-methyl-2-thiazolyl)-2 H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14H 13N 3O 4S 2 and it has the following structural formula:. Meloxicam is a pastel yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P)app = 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in Meloxicam tablets USP include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium citrate dihydrate.</Description>
</NDC>
<NDC>
<NDCCode>68071-1994-3</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (68071-1994-3) </PackageDescription>
<NDC11Code>68071-1994-03</NDC11Code>
<ProductNDC>68071-1994</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meloxicam</ProprietaryName>
<NonProprietaryName>Meloxicam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070307</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077927</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>MELOXICAM</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180117</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Meloxicam tablets are a non-steroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) ( 1.1) , 2 Rheumatoid Arthritis (RA) ( 1.2) , 3 Juvenile Rheumatoid Arthritis (JRA) in patients who weigh ≥60 kg ( 1.3) .</IndicationAndUsage>
<Description>Meloxicam Tablets USP are a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl- N-(5-methyl-2-thiazolyl)-2 H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14H 13N 3O 4S 2 and it has the following structural formula:. Meloxicam is a pastel yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P)app = 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in Meloxicam tablets USP include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium citrate dihydrate.</Description>
</NDC>
<NDC>
<NDCCode>68071-1994-6</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (68071-1994-6) </PackageDescription>
<NDC11Code>68071-1994-06</NDC11Code>
<ProductNDC>68071-1994</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meloxicam</ProprietaryName>
<NonProprietaryName>Meloxicam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070307</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077927</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>MELOXICAM</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180117</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Meloxicam tablets are a non-steroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) ( 1.1) , 2 Rheumatoid Arthritis (RA) ( 1.2) , 3 Juvenile Rheumatoid Arthritis (JRA) in patients who weigh ≥60 kg ( 1.3) .</IndicationAndUsage>
<Description>Meloxicam Tablets USP are a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl- N-(5-methyl-2-thiazolyl)-2 H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14H 13N 3O 4S 2 and it has the following structural formula:. Meloxicam is a pastel yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P)app = 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in Meloxicam tablets USP include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium citrate dihydrate.</Description>
</NDC>
<NDC>
<NDCCode>68071-1994-9</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (68071-1994-9) </PackageDescription>
<NDC11Code>68071-1994-09</NDC11Code>
<ProductNDC>68071-1994</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meloxicam</ProprietaryName>
<NonProprietaryName>Meloxicam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070307</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077927</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>MELOXICAM</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180117</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Meloxicam tablets are a non-steroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) ( 1.1) , 2 Rheumatoid Arthritis (RA) ( 1.2) , 3 Juvenile Rheumatoid Arthritis (JRA) in patients who weigh ≥60 kg ( 1.3) .</IndicationAndUsage>
<Description>Meloxicam Tablets USP are a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl- N-(5-methyl-2-thiazolyl)-2 H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14H 13N 3O 4S 2 and it has the following structural formula:. Meloxicam is a pastel yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P)app = 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in Meloxicam tablets USP include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium citrate dihydrate.</Description>
</NDC>
<NDC>
<NDCCode>49288-0100-2</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (49288-0100-2)</PackageDescription>
<NDC11Code>49288-0100-02</NDC11Code>
<ProductNDC>49288-0100</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Coffee</ProprietaryName>
<NonProprietaryName>Coffee</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>ARABICA COFFEE BEAN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>FOR DIAGNOSTIC USE ONLY. This product has not been shown by adequate data to be safe and effective for therapeutic use according to Federal Register Notice dated November 16, 1994, Vol. 59, No. 220. The following allergenic extracts are "For Diagnostic Use Only": Coffee (Coffea arabic), Cottonseed (Gossypium spp.), Flaxseed (Linum usitatissimum), Leafhopper (Cicadellidae), Miller Moth (Night Flying Lepidoptera), Cricket (Gryllidae) and Moth (Frenatae). These extracts are intended for diagnostic testing of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories' allergenic extracts are manufactured from source material listed on the vial label. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms. All source materials are inspected by Antigen Laboratories' technical personnel in accordance with 21 CFR 680.1 (b) (I). The following "For Diagnostic Use Only" allergenic extracts are extracted at a 1:20 w/v or 1:50 w/v ratio of source material to extracting fluid:. The source material for Coffee is prepared by grinding the seed of the coffee plant (Coffea arabic). The source material for Cottonseed is prepared by grinding the seed of the cotton plant (Gossypium spp.). The source material for Flaxseed is prepared by grinding the seed of the flax plant (Linum usitatissimum). Leafhopper source material is pulverized whole bodies of Leafhoppers (Cicadellidae). Miller Moth source material is pulverized whole bodies of night flying moths (Lepidoptera). Cricket source material is pulverized whole bodies of crickets (Gryllidae). Moth source material is pulverized whole bodies of moths of the order Frenatae. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER:. INACTIVE INGREDIENTS. Sodium chloride……………………………………………………………………...0.95%. Sodium bicarbonate………………………………………………………………….0.24%. USP Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label.</Description>
</NDC>
<NDC>
<NDCCode>49288-0100-5</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (49288-0100-5)</PackageDescription>
<NDC11Code>49288-0100-05</NDC11Code>
<ProductNDC>49288-0100</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Coffee</ProprietaryName>
<NonProprietaryName>Coffee</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>ARABICA COFFEE BEAN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>FOR DIAGNOSTIC USE ONLY. This product has not been shown by adequate data to be safe and effective for therapeutic use according to Federal Register Notice dated November 16, 1994, Vol. 59, No. 220. The following allergenic extracts are "For Diagnostic Use Only": Coffee (Coffea arabic), Cottonseed (Gossypium spp.), Flaxseed (Linum usitatissimum), Leafhopper (Cicadellidae), Miller Moth (Night Flying Lepidoptera), Cricket (Gryllidae) and Moth (Frenatae). These extracts are intended for diagnostic testing of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories' allergenic extracts are manufactured from source material listed on the vial label. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms. All source materials are inspected by Antigen Laboratories' technical personnel in accordance with 21 CFR 680.1 (b) (I). The following "For Diagnostic Use Only" allergenic extracts are extracted at a 1:20 w/v or 1:50 w/v ratio of source material to extracting fluid:. The source material for Coffee is prepared by grinding the seed of the coffee plant (Coffea arabic). The source material for Cottonseed is prepared by grinding the seed of the cotton plant (Gossypium spp.). The source material for Flaxseed is prepared by grinding the seed of the flax plant (Linum usitatissimum). Leafhopper source material is pulverized whole bodies of Leafhoppers (Cicadellidae). Miller Moth source material is pulverized whole bodies of night flying moths (Lepidoptera). Cricket source material is pulverized whole bodies of crickets (Gryllidae). Moth source material is pulverized whole bodies of moths of the order Frenatae. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER:. INACTIVE INGREDIENTS. Sodium chloride……………………………………………………………………...0.95%. Sodium bicarbonate………………………………………………………………….0.24%. USP Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label.</Description>
</NDC>
<NDC>
<NDCCode>49288-0116-2</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (49288-0116-2)</PackageDescription>
<NDC11Code>49288-0116-02</NDC11Code>
<ProductNDC>49288-0116</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cottonseed</ProprietaryName>
<NonProprietaryName>Cottonseed</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>COTTON SEED</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Plant Proteins [CS],Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>FOR DIAGNOSTIC USE ONLY. This product has not been shown by adequate data to be safe and effective for therapeutic use according to Federal Register Notice dated November 16, 1994, Vol. 59, No. 220. The following allergenic extracts are "For Diagnostic Use Only": Coffee (Coffea arabic), Cottonseed (Gossypium spp.), Flaxseed (Linum usitatissimum), Leafhopper (Cicadellidae), Miller Moth (Night Flying Lepidoptera), Cricket (Gryllidae) and Moth (Frenatae). These extracts are intended for diagnostic testing of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories' allergenic extracts are manufactured from source material listed on the vial label. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms. All source materials are inspected by Antigen Laboratories' technical personnel in accordance with 21 CFR 680.1 (b) (I). The following "For Diagnostic Use Only" allergenic extracts are extracted at a 1:20 w/v or 1:50 w/v ratio of source material to extracting fluid:. The source material for Coffee is prepared by grinding the seed of the coffee plant (Coffea arabic). The source material for Cottonseed is prepared by grinding the seed of the cotton plant (Gossypium spp.). The source material for Flaxseed is prepared by grinding the seed of the flax plant (Linum usitatissimum). Leafhopper source material is pulverized whole bodies of Leafhoppers (Cicadellidae). Miller Moth source material is pulverized whole bodies of night flying moths (Lepidoptera). Cricket source material is pulverized whole bodies of crickets (Gryllidae). Moth source material is pulverized whole bodies of moths of the order Frenatae. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER:. INACTIVE INGREDIENTS. Sodium chloride……………………………………………………………………...0.95%. Sodium bicarbonate………………………………………………………………….0.24%. USP Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label.</Description>
</NDC>
<NDC>
<NDCCode>49288-0116-5</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (49288-0116-5)</PackageDescription>
<NDC11Code>49288-0116-05</NDC11Code>
<ProductNDC>49288-0116</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cottonseed</ProprietaryName>
<NonProprietaryName>Cottonseed</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>COTTON SEED</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Plant Proteins [CS],Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>FOR DIAGNOSTIC USE ONLY. This product has not been shown by adequate data to be safe and effective for therapeutic use according to Federal Register Notice dated November 16, 1994, Vol. 59, No. 220. The following allergenic extracts are "For Diagnostic Use Only": Coffee (Coffea arabic), Cottonseed (Gossypium spp.), Flaxseed (Linum usitatissimum), Leafhopper (Cicadellidae), Miller Moth (Night Flying Lepidoptera), Cricket (Gryllidae) and Moth (Frenatae). These extracts are intended for diagnostic testing of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories' allergenic extracts are manufactured from source material listed on the vial label. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms. All source materials are inspected by Antigen Laboratories' technical personnel in accordance with 21 CFR 680.1 (b) (I). The following "For Diagnostic Use Only" allergenic extracts are extracted at a 1:20 w/v or 1:50 w/v ratio of source material to extracting fluid:. The source material for Coffee is prepared by grinding the seed of the coffee plant (Coffea arabic). The source material for Cottonseed is prepared by grinding the seed of the cotton plant (Gossypium spp.). The source material for Flaxseed is prepared by grinding the seed of the flax plant (Linum usitatissimum). Leafhopper source material is pulverized whole bodies of Leafhoppers (Cicadellidae). Miller Moth source material is pulverized whole bodies of night flying moths (Lepidoptera). Cricket source material is pulverized whole bodies of crickets (Gryllidae). Moth source material is pulverized whole bodies of moths of the order Frenatae. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER:. INACTIVE INGREDIENTS. Sodium chloride……………………………………………………………………...0.95%. Sodium bicarbonate………………………………………………………………….0.24%. USP Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label.</Description>
</NDC>
<NDC>
<NDCCode>49288-0160-2</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (49288-0160-2)</PackageDescription>
<NDC11Code>49288-0160-02</NDC11Code>
<ProductNDC>49288-0160</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cricket</ProprietaryName>
<NonProprietaryName>Cricket</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>ACHETA DOMESTICUS</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>FOR DIAGNOSTIC USE ONLY. This product has not been shown by adequate data to be safe and effective for therapeutic use according to Federal Register Notice dated November 16, 1994, Vol. 59, No. 220. The following allergenic extracts are "For Diagnostic Use Only": Coffee (Coffea arabic), Cottonseed (Gossypium spp.), Flaxseed (Linum usitatissimum), Leafhopper (Cicadellidae), Miller Moth (Night Flying Lepidoptera), Cricket (Gryllidae) and Moth (Frenatae). These extracts are intended for diagnostic testing of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories' allergenic extracts are manufactured from source material listed on the vial label. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms. All source materials are inspected by Antigen Laboratories' technical personnel in accordance with 21 CFR 680.1 (b) (I). The following "For Diagnostic Use Only" allergenic extracts are extracted at a 1:20 w/v or 1:50 w/v ratio of source material to extracting fluid:. The source material for Coffee is prepared by grinding the seed of the coffee plant (Coffea arabic). The source material for Cottonseed is prepared by grinding the seed of the cotton plant (Gossypium spp.). The source material for Flaxseed is prepared by grinding the seed of the flax plant (Linum usitatissimum). Leafhopper source material is pulverized whole bodies of Leafhoppers (Cicadellidae). Miller Moth source material is pulverized whole bodies of night flying moths (Lepidoptera). Cricket source material is pulverized whole bodies of crickets (Gryllidae). Moth source material is pulverized whole bodies of moths of the order Frenatae. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER:. INACTIVE INGREDIENTS. Sodium chloride……………………………………………………………………...0.95%. Sodium bicarbonate………………………………………………………………….0.24%. USP Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label.</Description>
</NDC>
<NDC>
<NDCCode>49288-0160-5</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (49288-0160-5)</PackageDescription>
<NDC11Code>49288-0160-05</NDC11Code>
<ProductNDC>49288-0160</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cricket</ProprietaryName>
<NonProprietaryName>Cricket</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>ACHETA DOMESTICUS</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>FOR DIAGNOSTIC USE ONLY. This product has not been shown by adequate data to be safe and effective for therapeutic use according to Federal Register Notice dated November 16, 1994, Vol. 59, No. 220. The following allergenic extracts are "For Diagnostic Use Only": Coffee (Coffea arabic), Cottonseed (Gossypium spp.), Flaxseed (Linum usitatissimum), Leafhopper (Cicadellidae), Miller Moth (Night Flying Lepidoptera), Cricket (Gryllidae) and Moth (Frenatae). These extracts are intended for diagnostic testing of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories' allergenic extracts are manufactured from source material listed on the vial label. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms. All source materials are inspected by Antigen Laboratories' technical personnel in accordance with 21 CFR 680.1 (b) (I). The following "For Diagnostic Use Only" allergenic extracts are extracted at a 1:20 w/v or 1:50 w/v ratio of source material to extracting fluid:. The source material for Coffee is prepared by grinding the seed of the coffee plant (Coffea arabic). The source material for Cottonseed is prepared by grinding the seed of the cotton plant (Gossypium spp.). The source material for Flaxseed is prepared by grinding the seed of the flax plant (Linum usitatissimum). Leafhopper source material is pulverized whole bodies of Leafhoppers (Cicadellidae). Miller Moth source material is pulverized whole bodies of night flying moths (Lepidoptera). Cricket source material is pulverized whole bodies of crickets (Gryllidae). Moth source material is pulverized whole bodies of moths of the order Frenatae. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER:. INACTIVE INGREDIENTS. Sodium chloride……………………………………………………………………...0.95%. Sodium bicarbonate………………………………………………………………….0.24%. USP Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label.</Description>
</NDC>
<NDC>
<NDCCode>49288-0201-2</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (49288-0201-2)</PackageDescription>
<NDC11Code>49288-0201-02</NDC11Code>
<ProductNDC>49288-0201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Flaxseed</ProprietaryName>
<NonProprietaryName>Flaxseed</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>FLAX SEED</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>FOR DIAGNOSTIC USE ONLY. This product has not been shown by adequate data to be safe and effective for therapeutic use according to Federal Register Notice dated November 16, 1994, Vol. 59, No. 220. The following allergenic extracts are "For Diagnostic Use Only": Coffee (Coffea arabic), Cottonseed (Gossypium spp.), Flaxseed (Linum usitatissimum), Leafhopper (Cicadellidae), Miller Moth (Night Flying Lepidoptera), Cricket (Gryllidae) and Moth (Frenatae). These extracts are intended for diagnostic testing of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories' allergenic extracts are manufactured from source material listed on the vial label. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms. All source materials are inspected by Antigen Laboratories' technical personnel in accordance with 21 CFR 680.1 (b) (I). The following "For Diagnostic Use Only" allergenic extracts are extracted at a 1:20 w/v or 1:50 w/v ratio of source material to extracting fluid:. The source material for Coffee is prepared by grinding the seed of the coffee plant (Coffea arabic). The source material for Cottonseed is prepared by grinding the seed of the cotton plant (Gossypium spp.). The source material for Flaxseed is prepared by grinding the seed of the flax plant (Linum usitatissimum). Leafhopper source material is pulverized whole bodies of Leafhoppers (Cicadellidae). Miller Moth source material is pulverized whole bodies of night flying moths (Lepidoptera). Cricket source material is pulverized whole bodies of crickets (Gryllidae). Moth source material is pulverized whole bodies of moths of the order Frenatae. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER:. INACTIVE INGREDIENTS. Sodium chloride……………………………………………………………………...0.95%. Sodium bicarbonate………………………………………………………………….0.24%. USP Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label.</Description>
</NDC>
<NDC>
<NDCCode>49288-0201-5</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (49288-0201-5)</PackageDescription>
<NDC11Code>49288-0201-05</NDC11Code>
<ProductNDC>49288-0201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Flaxseed</ProprietaryName>
<NonProprietaryName>Flaxseed</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>FLAX SEED</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>FOR DIAGNOSTIC USE ONLY. This product has not been shown by adequate data to be safe and effective for therapeutic use according to Federal Register Notice dated November 16, 1994, Vol. 59, No. 220. The following allergenic extracts are "For Diagnostic Use Only": Coffee (Coffea arabic), Cottonseed (Gossypium spp.), Flaxseed (Linum usitatissimum), Leafhopper (Cicadellidae), Miller Moth (Night Flying Lepidoptera), Cricket (Gryllidae) and Moth (Frenatae). These extracts are intended for diagnostic testing of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories' allergenic extracts are manufactured from source material listed on the vial label. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms. All source materials are inspected by Antigen Laboratories' technical personnel in accordance with 21 CFR 680.1 (b) (I). The following "For Diagnostic Use Only" allergenic extracts are extracted at a 1:20 w/v or 1:50 w/v ratio of source material to extracting fluid:. The source material for Coffee is prepared by grinding the seed of the coffee plant (Coffea arabic). The source material for Cottonseed is prepared by grinding the seed of the cotton plant (Gossypium spp.). The source material for Flaxseed is prepared by grinding the seed of the flax plant (Linum usitatissimum). Leafhopper source material is pulverized whole bodies of Leafhoppers (Cicadellidae). Miller Moth source material is pulverized whole bodies of night flying moths (Lepidoptera). Cricket source material is pulverized whole bodies of crickets (Gryllidae). Moth source material is pulverized whole bodies of moths of the order Frenatae. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER:. INACTIVE INGREDIENTS. Sodium chloride……………………………………………………………………...0.95%. Sodium bicarbonate………………………………………………………………….0.24%. USP Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label.</Description>
</NDC>
<NDC>
<NDCCode>49288-0461-2</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (49288-0461-2)</PackageDescription>
<NDC11Code>49288-0461-02</NDC11Code>
<ProductNDC>49288-0461</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Miller Moth</ProprietaryName>
<NonProprietaryName>Miller Moth</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>SITOTROGA CEREALELLA</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>FOR DIAGNOSTIC USE ONLY. This product has not been shown by adequate data to be safe and effective for therapeutic use according to Federal Register Notice dated November 16, 1994, Vol. 59, No. 220. The following allergenic extracts are "For Diagnostic Use Only": Coffee (Coffea arabic), Cottonseed (Gossypium spp.), Flaxseed (Linum usitatissimum), Leafhopper (Cicadellidae), Miller Moth (Night Flying Lepidoptera), Cricket (Gryllidae) and Moth (Frenatae). These extracts are intended for diagnostic testing of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories' allergenic extracts are manufactured from source material listed on the vial label. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms. All source materials are inspected by Antigen Laboratories' technical personnel in accordance with 21 CFR 680.1 (b) (I). The following "For Diagnostic Use Only" allergenic extracts are extracted at a 1:20 w/v or 1:50 w/v ratio of source material to extracting fluid:. The source material for Coffee is prepared by grinding the seed of the coffee plant (Coffea arabic). The source material for Cottonseed is prepared by grinding the seed of the cotton plant (Gossypium spp.). The source material for Flaxseed is prepared by grinding the seed of the flax plant (Linum usitatissimum). Leafhopper source material is pulverized whole bodies of Leafhoppers (Cicadellidae). Miller Moth source material is pulverized whole bodies of night flying moths (Lepidoptera). Cricket source material is pulverized whole bodies of crickets (Gryllidae). Moth source material is pulverized whole bodies of moths of the order Frenatae. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER:. INACTIVE INGREDIENTS. Sodium chloride……………………………………………………………………...0.95%. Sodium bicarbonate………………………………………………………………….0.24%. USP Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label.</Description>
</NDC>
<NDC>
<NDCCode>49288-0461-5</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (49288-0461-5)</PackageDescription>
<NDC11Code>49288-0461-05</NDC11Code>
<ProductNDC>49288-0461</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Miller Moth</ProprietaryName>
<NonProprietaryName>Miller Moth</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>SITOTROGA CEREALELLA</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>FOR DIAGNOSTIC USE ONLY. This product has not been shown by adequate data to be safe and effective for therapeutic use according to Federal Register Notice dated November 16, 1994, Vol. 59, No. 220. The following allergenic extracts are "For Diagnostic Use Only": Coffee (Coffea arabic), Cottonseed (Gossypium spp.), Flaxseed (Linum usitatissimum), Leafhopper (Cicadellidae), Miller Moth (Night Flying Lepidoptera), Cricket (Gryllidae) and Moth (Frenatae). These extracts are intended for diagnostic testing of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories' allergenic extracts are manufactured from source material listed on the vial label. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms. All source materials are inspected by Antigen Laboratories' technical personnel in accordance with 21 CFR 680.1 (b) (I). The following "For Diagnostic Use Only" allergenic extracts are extracted at a 1:20 w/v or 1:50 w/v ratio of source material to extracting fluid:. The source material for Coffee is prepared by grinding the seed of the coffee plant (Coffea arabic). The source material for Cottonseed is prepared by grinding the seed of the cotton plant (Gossypium spp.). The source material for Flaxseed is prepared by grinding the seed of the flax plant (Linum usitatissimum). Leafhopper source material is pulverized whole bodies of Leafhoppers (Cicadellidae). Miller Moth source material is pulverized whole bodies of night flying moths (Lepidoptera). Cricket source material is pulverized whole bodies of crickets (Gryllidae). Moth source material is pulverized whole bodies of moths of the order Frenatae. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER:. INACTIVE INGREDIENTS. Sodium chloride……………………………………………………………………...0.95%. Sodium bicarbonate………………………………………………………………….0.24%. USP Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label.</Description>
</NDC>
<NDC>
<NDCCode>68071-1212-5</NDCCode>
<PackageDescription>14 CAPSULE in 1 BOTTLE (68071-1212-5) </PackageDescription>
<NDC11Code>68071-1212-05</NDC11Code>
<ProductNDC>68071-1212</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160629</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090705</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin is indicated for: 1 Postherpetic neuralgia in adults ( 1) , 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy ( 1) .</IndicationAndUsage>
<Description>The active ingredient in gabapentin capsules is gabapentin, USP which has the chemical name 1-(aminomethyl) cyclohexane acetic acid. The molecular formula of gabapentin is C 9H 17NO 2 and a molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin, USP is a white to off-white crystalline solid with a pK a1 of 3.7 and a pK a2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Gabapentin Capsules, USP are supplied as imprinted hard gelatin capsules containing 100 mg, 300 mg and 400 mg of gabapentin, USP. The inactive ingredients are mannitol, pre-gelatinized starch and talc. The 100 mg capsule shell contains titanium dioxide. The 300 mg capsule contains FD&C Red 40, D&C Yellow 10 and titanium dioxide. The 400 mg capsule shell contains FD&C Red 40, D&C Yellow 10 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>68071-1330-5</NDCCode>
<PackageDescription>25 TABLET in 1 BOTTLE (68071-1330-5) </PackageDescription>
<NDC11Code>68071-1330-05</NDC11Code>
<ProductNDC>68071-1330</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitroglycerin</ProprietaryName>
<NonProprietaryName>Nitroglycerin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20160829</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208191</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>NITROGLYCERIN</SubstanceName>
<StrengthNumber>.4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170719</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nitroglycerin sublingual tablets are indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.</IndicationAndUsage>
<Description>Nitroglycerin is a stabilized sublingual compressed nitroglycerin tablet that contains 0.3 mg, 0.4 mg, or 0.6 mg nitroglycerin USP; as well as calcium stearate powder, colloidal silicon dioxide, hydrogenated vegetable oil, lactose monohydrate, and pregelatinized starch. Nitroglycerin, an organic nitrate, is a vasodilating agent. The chemical name for nitroglycerin is 1, 2, 3 propanetriol trinitrate and the chemical structure is:. Molecular weight: 227.09.</Description>
</NDC>
<NDC>
<NDCCode>68071-1332-5</NDCCode>
<PackageDescription>15 mL in 1 BOX (68071-1332-5)</PackageDescription>
<NDC11Code>68071-1332-05</NDC11Code>
<ProductNDC>68071-1332</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Proparacaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Proparacaine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>19950929</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040074</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>PROPARACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Local Anesthesia [PE],Local Anesthetic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>68071-1333-5</NDCCode>
<PackageDescription>25 g in 1 BOX (68071-1333-5) </PackageDescription>
<NDC11Code>68071-1333-05</NDC11Code>
<ProductNDC>68071-1333</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Silver Sulfadiazine</ProprietaryName>
<NonProprietaryName>Silver Sulfadiazine</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19851223</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018810</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>SILVER SULFADIAZINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Sulfonamide Antibacterial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170804</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Silver sulfadiazine cream, USP 1% is a topical antimicrobial drug indicated as an adjunct for the prevention and treatment of wound sepsis in patients with second and third degree burns.</IndicationAndUsage>
<Description>Silver sulfadiazine cream, USP 1% is a soft, white, water dispersible cream containing the antimicrobial agent silver sulfadiazine in micronized form for topical application. Each gram of silver sulfadiazine cream contains 10mg of micronized silver sulfadiazine. This active agent has the following structural formula:. Silver sulfadiazine cream contains 1% w/w silver sulfadiazine. The vehicle in which the active ingredient is dispersed consists of water, stearyl alcohol, white petrolatum, polyoxyl 40 stearate, propylene glycol, isopropyl myristate, and sorbitan monooleate with 0.3% methylparaben as a preservative.</Description>
</NDC>
<NDC>
<NDCCode>68071-1395-5</NDCCode>
<PackageDescription>45 CAPSULE in 1 BOTTLE (68071-1395-5) </PackageDescription>
<NDC11Code>68071-1395-05</NDC11Code>
<ProductNDC>68071-1395</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benzonatate</ProprietaryName>
<NonProprietaryName>Benzonatate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181221</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206948</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>BENZONATATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191004</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Benzonatate capsules, USP are indicated for the symptomatic relief of cough.</IndicationAndUsage>
<Description>Benzonatate capsules, USP, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26- onaoxaoctacosan-28-ylp-(butylamino) benzoate; with a molecular weight of 603.7. Each benzonatate capsules, USP for oral administration contains 100 mg or 200 mg benzonatate, USP. In addition, each capsule contains the following inactive ingredients: D&C Yellow #10, gelatin, glycerin, lecithin, light mineral oil, propylene glycol, purified water, shellac glaze, titanium dioxide, and white edible ink.</Description>
</NDC>
<NDC>
<NDCCode>68071-1513-5</NDCCode>
<PackageDescription>3.5 g in 1 BOX (68071-1513-5) </PackageDescription>
<NDC11Code>68071-1513-05</NDC11Code>
<ProductNDC>68071-1513</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gentak</ProprietaryName>
<NonProprietaryName>Gentamicin Sulfate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20060508</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064093</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>GENTAMICIN SULFATE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gentamicin sulfate ophthalmic ointment is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharonconjunctivitis: acute meibomianitis, and dacryocystitis, caused by susceptible strains of the following microorganisms: : 1 Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.</IndicationAndUsage>
<Description>GENTAK ® Gentamicin sulfate is a water soluble antibiotic of the aminoglycoside group. Gentamicin sulfate ophthalmic ointment is a sterile ointment for ophthalmic use. Each gram contains gentamicin sulfate equivalent to 3 mg gentamicin in a base of white petrolatum and mineral oil, with methylparaben and propylparaben as preservatives. Gentamicin is obtained from cultures of Micromonospora purpurea. It is a mixture of the sulfate salts of gentamicin C 1 C 2, and C 1A. All three components appear to have similar antimicrobial activities. Gentamicin sulfate occurs as a white to buff powder and is soluble in water and insoluble in alcohol. The structural formula is as follows:.</Description>
</NDC>
<NDC>
<NDCCode>68071-1525-5</NDCCode>
<PackageDescription>200 AEROSOL, METERED in 1 BOX (68071-1525-5) </PackageDescription>
<NDC11Code>68071-1525-05</NDC11Code>
<ProductNDC>68071-1525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Proair</ProprietaryName>
<ProprietaryNameSuffix>Hfa</ProprietaryNameSuffix>
<NonProprietaryName>Albuterol Sulfate</NonProprietaryName>
<DosageFormName>AEROSOL, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20121203</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021457</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>ALBUTEROL SULFATE</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170804</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PROAIR HFA Inhalation Aerosol is a beta 2-adrenergic agonist indicated for: : 1 Treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. ( 1.1) , 2 Prevention of exercise-induced bronchospasm in patients 4 years of age and older. ( 1.2) .</IndicationAndUsage>
<Description>The active ingredient of PROAIR HFA (albuterol sulfate) Inhalation Aerosol is albuterol sulfate, a racemic salt, of albuterol. Albuterol sulfate has the chemical name α 1-[( tert-butylamino) methyl]-4-hydroxy- m-xylene-α,α'-diol sulfate (2:1) (salt), and has the following chemical structure:. The molecular weight of albuterol sulfate is 576.7, and the empirical formula is (C 13H 21NO 3) 2H 2SO 4. Albuterol sulfate is a white to off-white crystalline powder. It is soluble in water and slightly soluble in ethanol. Albuterol sulfate is the official generic name in the United States, and salbutamol sulfate is the World Health Organization recommended generic name. PROAIR HFA Inhalation Aerosol is a pressurized metered-dose aerosol unit with a dose counter. PROAIR HFA is for oral inhalation only. It contains a microcrystalline suspension of albuterol sulfate in propellant HFA-134a (1, 1, 1, 2-tetrafluoroethane) and ethanol. Prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks by releasing three sprays into the air, away from the face. After priming, each actuation delivers 108 mcg albuterol sulfate, from the actuator mouthpiece (equivalent to 90 mcg of albuterol base). Each canister provides 200 actuations (inhalations). This product does not contain chlorofluorocarbons (CFCs) as the propellant.</Description>
</NDC>
<NDC>
<NDCCode>68071-1527-5</NDCCode>
<PackageDescription>15 mL in 1 BOTTLE (68071-1527-5) </PackageDescription>
<NDC11Code>68071-1527-05</NDC11Code>
<ProductNDC>68071-1527</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azithromycin</ProprietaryName>
<NonProprietaryName>Azithromycin</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065246</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>AZITHROMYCIN MONOHYDRATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170718</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Azithromycin for oral suspension is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications [see Dosage and Administration (2)].</IndicationAndUsage>
<Description>Azithromycin for oral suspension USP contains the active ingredient azithromycin, USP, a macrolide antibacterial drug, for oral administration. Azithromycin, USP has the chemical name (2 R,3 S,4 R,5 R,8 R,10 R,11 R,12 S,13 S,14 R)-13-[(2,6-dideoxy-3- C-methyl-3- O-methyl-α-L- ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D- xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin, USP is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Azithromycin, USP has the following structural formula. C 38H 72N 2O 12 M.W. 749. Azithromycin, USP, as the monohydrate, is a white crystalline powder with a molecular formula of C 38H 72N 2O 12H 2O and a molecular weight of 767. Azithromycin for oral suspension USP is supplied in bottles containing azithromycin monohydrate powder equivalent to 300 mg, 600 mg, 900 mg or 1200 mg azithromycin, USP per bottle and the following inactive ingredients: ammonio methacrylate copolymer, banana flavor, cherry flavor, colloidal silicon dioxide, FD&C Red No. 40, hydroxypropyl cellulose, sucrose, tribasic sodium phosphate anhydrous, vanilla flavor, and xanthan gum. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin, USP.</Description>
</NDC>
<NDC>
<NDCCode>68071-1528-5</NDCCode>
<PackageDescription>15 mL in 1 BOTTLE (68071-1528-5) </PackageDescription>
<NDC11Code>68071-1528-05</NDC11Code>
<ProductNDC>68071-1528</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azithromycin</ProprietaryName>
<NonProprietaryName>Azithromycin</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101217</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065246</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>AZITHROMYCIN MONOHYDRATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170718</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Azithromycin for oral suspension is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications [see Dosage and Administration (2)].</IndicationAndUsage>
<Description>Azithromycin for oral suspension USP contains the active ingredient azithromycin, USP, a macrolide antibacterial drug, for oral administration. Azithromycin, USP has the chemical name (2 R,3 S,4 R,5 R,8 R,10 R,11 R,12 S,13 S,14 R)-13-[(2,6-dideoxy-3- C-methyl-3- O-methyl-α-L- ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D- xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin, USP is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Azithromycin, USP has the following structural formula. C 38H 72N 2O 12 M.W. 749. Azithromycin, USP, as the monohydrate, is a white crystalline powder with a molecular formula of C 38H 72N 2O 12H 2O and a molecular weight of 767. Azithromycin for oral suspension USP is supplied in bottles containing azithromycin monohydrate powder equivalent to 300 mg, 600 mg, 900 mg or 1200 mg azithromycin, USP per bottle and the following inactive ingredients: ammonio methacrylate copolymer, banana flavor, cherry flavor, colloidal silicon dioxide, FD&C Red No. 40, hydroxypropyl cellulose, sucrose, tribasic sodium phosphate anhydrous, vanilla flavor, and xanthan gum. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin, USP.</Description>
</NDC>
<NDC>
<NDCCode>68071-1530-5</NDCCode>
<PackageDescription>5 mL in 1 BOX (68071-1530-5) </PackageDescription>
<NDC11Code>68071-1530-05</NDC11Code>
<ProductNDC>68071-1530</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin</ProprietaryName>
<NonProprietaryName>Ciprofloxacin Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20080320</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077689</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>3.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC],Quinolones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-04-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170712</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68071-1538-5</NDCCode>
<PackageDescription>45 g in 1 BOX (68071-1538-5) </PackageDescription>
<NDC11Code>68071-1538-05</NDC11Code>
<ProductNDC>68071-1538</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mometasone Furoate</ProprietaryName>
<NonProprietaryName>Mometasone Furoate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080528</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078541</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>MOMETASONE FUROATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170725</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mometasone furoate cream USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 2 years of age or older.</IndicationAndUsage>
<Description>Mometasone furoate cream USP, 0.1% contains mometasone furoate USP for topical use. Mometasone furoate USP is a synthetic corticosteroid with anti-inflammatory activity. Chemically, mometasone furoate USP is 9α,21-dichloro-11β,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-(2-furoate), with the empirical formula C 27H 30CI 2O 6, a molecular weight of 521.43 and the following structural formula:. Mometasone furoate USP is a white to off-white powder, soluble in acetone and methylene chloride. Each gram of mometasone furoate cream USP, 0.1% contains: 1 mg mometasone furoate USP in a cream base of hexylene glycol, phosphoric acid, propylene glycol stearate (55% monoester), stearyl alcohol and ceteareth-20, titanium dioxide, aluminum starch octenylsuccinate (Gamma Irradiated), white wax, white petrolatum, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>68071-1550-6</NDCCode>
<PackageDescription>2.5 mL in 1 VIAL (68071-1550-6) </PackageDescription>
<NDC11Code>68071-1550-06</NDC11Code>
<ProductNDC>68071-1550</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ipratropium Bromide</ProprietaryName>
<NonProprietaryName>Ipratropium Bromide</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075693</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>IPRATROPIUM BROMIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/2.5mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC],Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-04-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>