{
"NDC": [
{
"NDCCode": "0268-0291-10",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (0268-0291-10) ",
"NDC11Code": "00268-0291-10",
"ProductNDC": "0268-0291",
"ProductTypeName": "STANDARDIZED ALLERGENIC",
"ProprietaryName": "Meadow Fescue Grass, Standardized",
"NonProprietaryName": "Meadow Fescue Grass, Standardized",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "19971218",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103053",
"LabelerName": "ALK-Abello, Inc.",
"SubstanceName": "FESTUCA PRATENSIS POLLEN",
"StrengthNumber": "100000",
"StrengthUnit": "[BAU]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2023-05-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19971218",
"SamplePackage": "N",
"IndicationAndUsage": "Indicated use of allergenic extracts is for the diagnosis and treatment (hyposensitization therapy) of patients who experience allergic symptoms due to exposure to grass pollen and who exhibit type I skin sensitivity when tested to those specific allergens. Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust mites, molds, animal danders, and various other inhalants in situations where the offending allergen cannot be avoided. For previously untreated patients, prior to the initiation of therapy, clinical sensitivity to the standardized grass pollen extract should be established by careful evaluation of the patient's history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can easily be avoided. 10,000 BAU/mL extracts are indicated for percutaneous testing. If negative, the 100,000 BAU/mL dose may be used. Availability of 10,000 and 100,000 BAU/mL dosages facilitate safe switching. Patients who tolerate dilutions prepared from the 10,000 BAU/mL dosage and require a higher dose may be treated with dilutions prepared from the 100,000 BAU/mL dosage. 100,000 BAU/mL concentrations may be especially useful when patients are hyposensitized to numerous allergens. Mixing of allergenic extracts dilutes the potency of each constituent. Using higher concentrations such as 100,000 BAU/mL allows for dilution with other extracts without sacrificing immunizing properties. CAUTION: The final potency of each individual component in a patient mixture should never exceed 10,000 BAU/mL. See also, DOSAGE AND ADMINISTRATION section for discussion of mixture labeling.",
"Description": "Standardized allergenic extract of grass pollens from Timothy (Phleum pratense), Orchard (Dactylis glomerata), June (Poa pratensis), Red Top (Agrostis alba), Sweet Vernal (Anthoxanthum odoratum), Meadow Fescue (Festuca elatior), Perennial Rye (Lolium perenne), Bermuda Grass (Cynodon dactylon), in the accompanying vial are sterile, and contain glycerin 50% v/v and phenol 0.4% (preservative). Inert ingredients may include sodium chloride for isotonicity and sodium bicarbonate buffer. Glycerinated pollen extracts, for subcutaneous injection for immunotherapy and/or percutaneous or intracutaneous testing (see Dosage and Administration section), are prepared from defatted dried pollen extracted in glycerinated Coca’s Fluid, filtered aseptically, and dispensed into multiple dose vials. These are subsequently tested for sterility, safety, and potency. For ease in use and for lot-to-lot consistency, the potency is expressed in Bioequivalent Allergy Units (BAUs) per milliliter. A value of 10,000 BAU/mL is assigned to the CBER reference standard that can be diluted 1:0.5 million to produce intradermal ƩE (sum of Erythema) of 50 mm in highly puncture reactive subjects1. A value of 100,000 BAU/mL is assigned to the CBER reference standard that can be diluted 1:5 million to produce intradermal ƩE (sum of Erythema) of 50 mm in highly puncture reactive subjects. The relative potency of each lot of standardized extract has been compared to the official CBER reference standard by an acceptable assay such as ELISA Inhibition.2 When the potency is equivalent by ELISA Inhibition to the reference, the product is assigned 10,000 BAU/mL or 100,000 BAU/mL. Standardized grass pollen extracts, except for Bermuda, have potency designations of either 10,000 BAU/mL or 100,000 BAU/mL. Bermuda grass pollen extract is only available with a 10,000 BAU/mL potency designation. In the ELISA Inhibition assay, a competitive binding assay, the wells of microtiter plates are coated using a characterized allergenic extract. Allergic sera is added to each well. The binding of IgE specific for the coating allergen is inhibited by concentrations of a test sample of an extract of the same allergen. The amount of IgE bound to the solid phase allergen (and subsequently the degree of inhibition) is determined using enzyme-labeled anti-human IgE antibodies and the appropriate substrate. The potency relative to a reference is determined using a parallel line bioassay method."
},
{
"NDCCode": "0268-0291-50",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (0268-0291-50) ",
"NDC11Code": "00268-0291-50",
"ProductNDC": "0268-0291",
"ProductTypeName": "STANDARDIZED ALLERGENIC",
"ProprietaryName": "Meadow Fescue Grass, Standardized",
"NonProprietaryName": "Meadow Fescue Grass, Standardized",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "19971218",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103053",
"LabelerName": "ALK-Abello, Inc.",
"SubstanceName": "FESTUCA PRATENSIS POLLEN",
"StrengthNumber": "100000",
"StrengthUnit": "[BAU]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2023-05-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19971218",
"SamplePackage": "N",
"IndicationAndUsage": "Indicated use of allergenic extracts is for the diagnosis and treatment (hyposensitization therapy) of patients who experience allergic symptoms due to exposure to grass pollen and who exhibit type I skin sensitivity when tested to those specific allergens. Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust mites, molds, animal danders, and various other inhalants in situations where the offending allergen cannot be avoided. For previously untreated patients, prior to the initiation of therapy, clinical sensitivity to the standardized grass pollen extract should be established by careful evaluation of the patient's history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can easily be avoided. 10,000 BAU/mL extracts are indicated for percutaneous testing. If negative, the 100,000 BAU/mL dose may be used. Availability of 10,000 and 100,000 BAU/mL dosages facilitate safe switching. Patients who tolerate dilutions prepared from the 10,000 BAU/mL dosage and require a higher dose may be treated with dilutions prepared from the 100,000 BAU/mL dosage. 100,000 BAU/mL concentrations may be especially useful when patients are hyposensitized to numerous allergens. Mixing of allergenic extracts dilutes the potency of each constituent. Using higher concentrations such as 100,000 BAU/mL allows for dilution with other extracts without sacrificing immunizing properties. CAUTION: The final potency of each individual component in a patient mixture should never exceed 10,000 BAU/mL. See also, DOSAGE AND ADMINISTRATION section for discussion of mixture labeling.",
"Description": "Standardized allergenic extract of grass pollens from Timothy (Phleum pratense), Orchard (Dactylis glomerata), June (Poa pratensis), Red Top (Agrostis alba), Sweet Vernal (Anthoxanthum odoratum), Meadow Fescue (Festuca elatior), Perennial Rye (Lolium perenne), Bermuda Grass (Cynodon dactylon), in the accompanying vial are sterile, and contain glycerin 50% v/v and phenol 0.4% (preservative). Inert ingredients may include sodium chloride for isotonicity and sodium bicarbonate buffer. Glycerinated pollen extracts, for subcutaneous injection for immunotherapy and/or percutaneous or intracutaneous testing (see Dosage and Administration section), are prepared from defatted dried pollen extracted in glycerinated Coca’s Fluid, filtered aseptically, and dispensed into multiple dose vials. These are subsequently tested for sterility, safety, and potency. For ease in use and for lot-to-lot consistency, the potency is expressed in Bioequivalent Allergy Units (BAUs) per milliliter. A value of 10,000 BAU/mL is assigned to the CBER reference standard that can be diluted 1:0.5 million to produce intradermal ƩE (sum of Erythema) of 50 mm in highly puncture reactive subjects1. A value of 100,000 BAU/mL is assigned to the CBER reference standard that can be diluted 1:5 million to produce intradermal ƩE (sum of Erythema) of 50 mm in highly puncture reactive subjects. The relative potency of each lot of standardized extract has been compared to the official CBER reference standard by an acceptable assay such as ELISA Inhibition.2 When the potency is equivalent by ELISA Inhibition to the reference, the product is assigned 10,000 BAU/mL or 100,000 BAU/mL. Standardized grass pollen extracts, except for Bermuda, have potency designations of either 10,000 BAU/mL or 100,000 BAU/mL. Bermuda grass pollen extract is only available with a 10,000 BAU/mL potency designation. In the ELISA Inhibition assay, a competitive binding assay, the wells of microtiter plates are coated using a characterized allergenic extract. Allergic sera is added to each well. The binding of IgE specific for the coating allergen is inhibited by concentrations of a test sample of an extract of the same allergen. The amount of IgE bound to the solid phase allergen (and subsequently the degree of inhibition) is determined using enzyme-labeled anti-human IgE antibodies and the appropriate substrate. The potency relative to a reference is determined using a parallel line bioassay method."
},
{
"NDCCode": "0069-0291-10",
"PackageDescription": "10 CARTON in 1 CARTON (0069-0291-10) / 1 SYRINGE in 1 CARTON (0069-0291-01) / .5 mL in 1 SYRINGE",
"NDC11Code": "00069-0291-10",
"ProductNDC": "0069-0291",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nivestym",
"NonProprietaryName": "Filgrastim-aafi",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20180924",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761080",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "FILGRASTIM",
"StrengthNumber": "300",
"StrengthUnit": "ug/.5mL",
"Pharm_Classes": "Granulocyte Colony-Stimulating Factor [CS], Increased Myeloid Cell Production [PE], Leukocyte Growth Factor [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180924",
"SamplePackage": "N",
"IndicationAndUsage": "NIVESTYM is a leukocyte growth factor indicated to: 1 Decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever. (1.1), 2 Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML). (1.2), 3 Reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT). (1.3), 4 Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis. (1.4), 5 Reduce the incidence and duration of sequelae of severe neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia. (1.5).",
"Description": "Filgrastim-aafi is a 175 amino acid human granulocyte colony-stimulating factor (G-CSF) manufactured by recombinant DNA technology. NIVESTYM is produced by Escherichia coli (E coli) bacteria into which has been inserted the human granulocyte colony-stimulating factor gene. NIVESTYM has a molecular weight of 18‚799 daltons. The protein has an amino acid sequence that is identical to the natural sequence predicted from human DNA sequence analysis‚ except for the addition of an N-terminal methionine necessary for expression in E coli. Because NIVESTYM is produced in E coli‚ the product is non-glycosylated and thus differs from G-CSF isolated from a human cell. NIVESTYM is a sterile‚ clear‚ colorless‚ preservative-free liquid containing filgrastim-aafi injection for subcutaneous or intravenous use. The product is available in single-dose vials for subcutaneous or intravenous use and prefilled syringes for subcutaneous use. The single-dose vials contain either 300 mcg/mL or 480 mcg/1.6 mL of filgrastim-aafi. The single-dose prefilled syringes contain either 300 mcg/0.5 mL or 480 mcg/0.8 mL of filgrastim-aafi. The final pH range of the NIVESTYM drug product solution is 3.8 to 4.3. See Table 4 below for product composition of each single-dose vial or prefilled syringe."
},
{
"NDCCode": "0363-0291-03",
"PackageDescription": "10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0363-0291-03) ",
"NDC11Code": "00363-0291-03",
"ProductNDC": "0363-0291",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19880524",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075010",
"LabelerName": "Walgreen Company",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-10-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19880524",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to: toothachethe common coldmenstrual crampsheadacheminor pain of arthritisbackachemuscular aches. temporarily reduces fever."
},
{
"NDCCode": "21749-291-10",
"PackageDescription": "1000 mL in 1 BAG (21749-291-10) ",
"NDC11Code": "21749-0291-10",
"ProductNDC": "21749-291",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Signatry Ultra Antimicrobial Ltn Sp",
"NonProprietaryName": "Chloroxylenol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20010919",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "GOJO Industries, Inc.",
"SubstanceName": "CHLOROXYLENOL",
"StrengthNumber": ".003",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20010919",
"EndMarketingDatePackage": "20231231",
"SamplePackage": "N",
"IndicationAndUsage": " Handwash to help decrease bacteria on the skin. Recommended for repeated use."
},
{
"NDCCode": "27241-291-10",
"PackageDescription": "1000 CAPSULE in 1 BOTTLE (27241-291-10) ",
"NDC11Code": "27241-0291-10",
"ProductNDC": "27241-291",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Terazosin",
"NonProprietaryName": "Terazosin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250512",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219482",
"LabelerName": "Ajanta Pharma USA Inc.",
"SubstanceName": "TERAZOSIN HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250512",
"SamplePackage": "N",
"IndicationAndUsage": "Terazosin capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH). There is a rapid response, with approximately 70% of patients experiencing an increase in urinary flow and improvement in symptoms of BPH when treated with terazosin capsules. The long-term effects of terazosin capsules on the incidence of surgery, acute urinary obstruction or other complications of BPH are yet to be determined. Terazosin capsules are also indicated for the treatment of hypertension. Terazosin capsules can be used alone or in combination with other antihypertensive agents such as diuretics or beta-adrenergic blocking agents.",
"Description": "Terazosin hydrochloride USP, an alpha-1-selective adrenoceptor blocking agent, is a quinazoline derivative represented by the following chemical name, molecular formula and structural formula. Piperazine, 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-[(tetrahydro-2-furanyl)carbonyl]-, monohydrochloride, dihydrate. C19H25N5O4 HCl 2H2O. Terazosin hydrochloride, USP is a white to pale yellow, crystalline powder. Soluble in methanol, sparingly soluble in water, slightly soluble in alcohol and in 0.1 N hydrochloric acid, very slightly soluble in isotonic saline solution and in chloroform and practically insoluble in acetone and in hexanes and has a molecular weight of 459.93. Each capsule, for oral administration, contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and pregelatinized starch. The gelatin capsule contains gelatin, sodium lauryl sulfate, and titanium dioxide. The 1 mg shell also contains ferric oxide black; the 2 mg capsule shell also contains D&C Yellow-10; the 5 mg capsule shell also contains D&C Yellow-10, D&C Red-28 and FD&C Red-40; the 10 mg capsule shell also contains D&C Yellow-10 and FD&C Green-3. Imprinting ink contains shellac, propylene glycol, butyl alcohol, potassium hydroxide and black iron oxide. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "31722-291-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (31722-291-10) ",
"NDC11Code": "31722-0291-10",
"ProductNDC": "31722-291",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levothyroxine Sodium",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230118",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215259",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": ".137",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Active",
"LastUpdate": "2023-01-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230118",
"SamplePackage": "N",
"IndicationAndUsage": "Hypothyroidism. Levothyroxine sodium tablets are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression. Levothyroxine sodium tablets are indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: : 1 Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium tablets may induce hyperthyroidism [see Warnings and Precautions (5.4)]. , 2 Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.",
"Description": "Levothyroxine sodium tablets, USP contain synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt. Synthetic T4 is identical in chemical structure to the T4 produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4NNaO4 xH2O, molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown. Levothyroxine sodium tablets for oral administration are available in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients butylated hydroxyanisole, microcrystalline cellulose, sodium starch glycolate, povidone, colloidal silicon dioxide, magnesium stearate and color additive(s). Table 6 provides a listing of the color additives by tablet strength. FDA approved Dissolution test differs from the USP dissolution test. FDA approved Assay test differs from the USP assay test."
},
{
"NDCCode": "46708-291-10",
"PackageDescription": "100 TABLET in 1 CARTON (46708-291-10) ",
"NDC11Code": "46708-0291-10",
"ProductNDC": "46708-291",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate",
"NonProprietaryName": "Metoprolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130722",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202871",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2023-05-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130722",
"SamplePackage": "N",
"IndicationAndUsage": "Hypertension Metoprolol tartrate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents. Angina Pectoris Metoprolol tartrate tablets are indicated in the long-term treatment of angina pectoris. Myocardial Infarction. Metoprolol tartrate tablets are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality when used alone or in conjunction with intravenous metoprolol. Oral metoprolol therapy can be initiated after intravenous metoprolol therapy or, alternatively, oral treatment can begin within 3 to 10 days of the acute event (see DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, and WARNINGS.",
"Description": "Metoprolol tartrate, USP is a selective beta1-adrenoreceptor blocking agent, available as 25 mg, 50 mg and 100 mg tablets for oral administration. Metoprolol tartrate USP is (±)-1-(Isopropylamino)-3-[p-2-methoxyethyl)phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Each tablet for oral administration contains 25 mg, 50 mg or 100 mg of metoprolol tartrate and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, povidone, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate hypromellose, titanium dioxide and polyethylene glycol. In addition, the 50 mg product contains D&C Red No. 30 Aluminum Lake and the 100 mg product contains FD&C Blue No. 2 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake as coloring agents."
},
{
"NDCCode": "47285-291-10",
"PackageDescription": "145340 L in 1 DEWAR (47285-291-10) ",
"NDC11Code": "47285-0291-10",
"ProductNDC": "47285-291",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen",
"NonProprietaryName": "Oxygen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19410101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205767",
"LabelerName": "James C. Dawes Company, Inc",
"SubstanceName": "OXYGEN",
"StrengthNumber": "99",
"StrengthUnit": "L/100L",
"Status": "Deprecated",
"LastUpdate": "2022-03-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "19410101",
"SamplePackage": "N"
},
{
"NDCCode": "49281-291-10",
"PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-291-10) > .5 mL in 1 SYRINGE, GLASS",
"NDC11Code": "49281-0291-10",
"ProductNDC": "49281-291",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Decavac",
"NonProprietaryName": "Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated) And Corynebacterium Diphtheriae Toxoid Antigen (formaldehyde Inactivated)",
"DosageFormName": "SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20040324",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103921",
"LabelerName": "Sanofi Pasteur Inc.",
"SubstanceName": "CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)",
"StrengthNumber": "5; 2",
"StrengthUnit": "[Lf]/.5mL; [Lf]/.5mL",
"Pharm_Classes": "Inactivated Clostridium Tetani Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Tetanus Toxoid [Chemical/Ingredient],Inactivated Corynebacterium Diphtheriae Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Diphtheria Toxoid [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "49288-0291-3",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (49288-0291-3)",
"NDC11Code": "49288-0291-03",
"ProductNDC": "49288-0291",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Lobster",
"NonProprietaryName": "Lobster",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "LOBSTER",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Shellfish Proteins [EXT]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
"Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. 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%. 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 or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
},
{
"NDCCode": "50844-291-10",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (50844-291-10) / 40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "50844-0291-10",
"ProductNDC": "50844-291",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19880524",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075010",
"LabelerName": "L.N.K. International, Inc.",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19880524",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to:headachetoothachebackachemenstrual crampsthe common coldmuscular achesminor pain of arthritis. temporarily reduces fever."
},
{
"NDCCode": "52817-291-10",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (52817-291-10) ",
"NDC11Code": "52817-0291-10",
"ProductNDC": "52817-291",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxazepam",
"NonProprietaryName": "Oxazepam",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20210601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071026",
"LabelerName": "TruPharma, LLC",
"SubstanceName": "OXAZEPAM",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210601",
"SamplePackage": "N",
"Description": "Oxazepam, USP is the first of a chemical series of compounds known as the 3- hydroxybenzodiazepinones. A therapeutic agent providing versatility and flexibility in control of common emotional disturbances, this product exerts prompt action in a wide variety of disorders associated with anxiety, tension, agitation, and irritability, and anxiety associated with depression. In tolerance and toxicity studies on several animal species, this product reveals significantly greater safety factors than related compounds (chlordiazepoxide and diazepam) and manifests a wide separation of effective doses and doses inducing side effects. Oxazepam, is 7-chloro-1,3-dihydro-3-hydroxy-5-phenyl-2 H-1,4-benzodiazepin-2-one and has the following structural formula:. MW 286.72. Oxazepam is a white-crystalline powder. Each capsule for oral administration contain 10 mg, 15 mg or 30 mg of oxazepam. Inactive ingredients: croscarmellose sodium, D&C yellow #10, FD&C blue #1, FD&C blue # 2, FD&C red # 40, ferric oxide black, gelatin, lactose monohydrate, magnesium stearate, microcrystalline cellulose, n-butyl alcohol, propylene glycol, sda-3a alcohol, shellac, sodium lauryl sulfate, titanium dioxide and other inert ingredients. The 15 mg capsule also contains: FD&C yellow # 6. The 30 mg capsule also contains: D&C red # 28."
},
{
"NDCCode": "54575-291-10",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (54575-291-10)",
"NDC11Code": "54575-0291-10",
"ProductNDC": "54575-291",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dog Hair And Epithelia",
"NonProprietaryName": "Canis Lupus Familiaris Hair And Canis Lupus Familiaris Skin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19671207",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101376",
"LabelerName": "Allergy Laboratories, Inc.",
"SubstanceName": "CANIS LUPUS FAMILIARIS HAIR; CANIS LUPUS FAMILIARIS SKIN",
"StrengthNumber": "1; 1",
"StrengthUnit": "g/20mL; g/20mL",
"Pharm_Classes": "Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Animal Fur [CS],Allergens [CS],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
"Description": "Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established: Coffee Cottonseed Flaxseed Housefly Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens."
},
{
"NDCCode": "59779-291-10",
"PackageDescription": "1 BOTTLE in 1 PACKAGE (59779-291-10) / 10 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "59779-0291-10",
"ProductNDC": "59779-291",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19880524",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075010",
"LabelerName": "CVS Pharmacy",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19880524",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to:. toothache. backache. headache. muscular aches. menstrual cramps. the common cold. minor pain of arthritis. temporarily reduces fever."
},
{
"NDCCode": "62802-291-10",
"PackageDescription": "295 g in 1 CAN (62802-291-10)",
"NDC11Code": "62802-0291-10",
"ProductNDC": "62802-291",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "No-ad Kids Spf50 Continuous Mist Sunscreen",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Oxybenzone, Octocrylene",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Sun & Skin Care Research, LLC",
"SubstanceName": "HOMOSALATE; OCTISALATE; OXYBENZONE; OCTOCRYLENE; AVOBENZONE",
"StrengthNumber": "10; 5; 5; 2; 2",
"StrengthUnit": "g/100g; g/100g; g/100g; g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "helps prevent sunburn. If used as directed with other skin protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "64720-291-10",
"PackageDescription": "100 TABLET in 1 BOTTLE (64720-291-10) ",
"NDC11Code": "64720-0291-10",
"ProductNDC": "64720-291",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glyburide",
"NonProprietaryName": "Glyburide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160601",
"EndMarketingDate": "20190201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206079",
"LabelerName": "CorePharma, LLC",
"SubstanceName": "GLYBURIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea [EPC],Sulfonylurea Compounds [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160601",
"EndMarketingDatePackage": "20190201",
"SamplePackage": "N"
},
{
"NDCCode": "67877-291-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (67877-291-10) ",
"NDC11Code": "67877-0291-10",
"ProductNDC": "67877-291",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydralazine Hydrochloride",
"NonProprietaryName": "Hydralazine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200737",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "HYDRALAZINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Active",
"LastUpdate": "2018-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20091124",
"SamplePackage": "N",
"IndicationAndUsage": "Essential hypertension, alone or as an adjunct.",
"Description": "HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. C8H8N4 HClHydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg HydrALAZINE hydrochloride, USP. Tablets also contain microcrystalline cellulose, sodium starch glycolate, stearic acid, povidone K-30, colloidal silicon dioxide, mannitol and FD&C Yellow No 6."
},
{
"NDCCode": "69315-291-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (69315-291-10) ",
"NDC11Code": "69315-0291-10",
"ProductNDC": "69315-291",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Allopurinol",
"NonProprietaryName": "Allopurinol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214443",
"LabelerName": "Leading Pharma, LLC",
"SubstanceName": "ALLOPURINOL",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-09-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240501",
"SamplePackage": "N",
"IndicationAndUsage": "Allopurinol tablets are indicated for: 1 The management of adults with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy), 2 The management of adult and pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels, 3 The management of adult patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients, despite lifestyle changes (such as reduction of dietary sodium, non-dairy animal protein, oxylate rich foods, refined sugars and increases in oral fluids and fruits and vegetables).",
"Description": "Allopurinol is a xanthine oxidase inhibitor. It has the following structural formula. Allopurinol is known chemically as 1, 5-dihydro-4H-pyrazolo [3, 4-d]pyrimidin-4-one. and it has a molecular weight of 136.11 g/mol. Its solubility in water at 37°C is 80.0 mg/dL and is greater in an alkaline solution. It is a xanthine oxidase inhibitor which is administered orally. Each scored white to off white round tablet contains 100 mg allopurinol and the inactive ingredients crospovidone, colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch, and povidone. Each scored white to off white round tablet contains 200 mg allopurinol and the inactive ingredients crospovidone, colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch, and povidone. Each scored peach round tablet contains 300 mg allopurinol and the inactive ingredients crospovidone, colloidal silicon dioxide, FD&C Yellow No. 6 Lake, lactose monohydrate, magnesium stearate, pregelatinized starch and povidone."
},
{
"NDCCode": "69543-291-10",
"PackageDescription": "100 TABLET in 1 BOTTLE (69543-291-10) ",
"NDC11Code": "69543-0291-10",
"ProductNDC": "69543-291",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Albuterol",
"NonProprietaryName": "Albuterol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20181027",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211397",
"LabelerName": "Virtus Pharmaceuticals LLC",
"SubstanceName": "ALBUTEROL SULFATE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20181027",
"SamplePackage": "N",
"IndicationAndUsage": "Albuterol tablets are indicated for the relief of bronchospasm in adults and children 6 years of age and older with reversible obstructive airway disease.",
"Description": "Albuterol tablets contain albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta2-adrenergic bronchodilator. Albuterol sulfate has the chemical name α1-[(tert-Butylamino)methyl]-4-hydroxy-m-xylene-α,α'-diol sulfate (2:1) (salt) and the following structural formula. Albuterol sulfate has a molecular weight of 576.7, and the molecular formula is (C13H21NO3)2H2SO4. Albuterol sulfate is a white or practically white powder, freely soluble in water and slightly soluble in alcohol, chloroform and ether. The World Health Organization recommended name for albuterol base is salbutamol. Each albuterol sulfate tablet, for oral administration contains 2 or 4 mg of albuterol as 2.4 or 4.8 mg of albuterol sulfate, respectively. Each tablet also contains the following inactive ingredients: lactose anhydrous, magnesium stearate, pregelatinized starch, and sodium lauryl sulfate."
},
{
"NDCCode": "71335-0291-6",
"PackageDescription": "10 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0291-6) ",
"NDC11Code": "71335-0291-06",
"ProductNDC": "71335-0291",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole Sodium",
"NonProprietaryName": "Pantoprazole",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160620",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205119",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220628",
"SamplePackage": "N",
"IndicationAndUsage": "Pantoprazole sodium delayed-release tablets are indicated for.",
"Description": "The active ingredient in pantoprazole sodium delayed-release tablets USP, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S x 1.5 H2O, with a molecular weight of 432.4. The structural formula is. Pantoprazole sodium, USP sesquihydrate is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium, USP sesquihydrate is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole sodium, USP is supplied as a delayed-release tablet, available in two strengths (20 mg and 40 mg). Each pantoprazole sodium delayed-release tablet, USP contains 45.1 mg or 22.56 mg of pantoprazole sodium, USP sesquihydrate (equivalent to 40 mg or 20 mg pantoprazole, respectively). Pantoprazole sodium delayed-release tablets, USP contains the following inactive ingredients: ammonium hydroxide, crospovidone, hydroxyl propyl cellulose, hypromellose, iron oxide black, iron oxide yellow, mannitol, methacrylic acid copolymer dispersion, polyethylene glycol, polyvinyl alcohol, povidone, propylene glycol, shellac, sodium carbonate, sodium hydroxide, sodium stearyl fumarate, talc, titanium dioxide and triethyl citrate. Pantoprazole sodium delayed-release tablets, USP (40 mg and 20 mg) complies with USP dissolution test 2."
},
{
"NDCCode": "71919-291-10",
"PackageDescription": "100 mL in 1 BOTTLE, GLASS (71919-291-10) ",
"NDC11Code": "71919-0291-10",
"ProductNDC": "71919-291",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ferrum Phosphoricum",
"NonProprietaryName": "Ferrosoferric Phosphate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20100319",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "FERROSOFERRIC PHOSPHATE",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2022-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20100319",
"SamplePackage": "N"
},
{
"NDCCode": "75839-291-10",
"PackageDescription": "1 kg in 1 BOTTLE (75839-291-10)",
"NDC11Code": "75839-0291-10",
"ProductNDC": "75839-291",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Ambroxol",
"DosageFormName": "POWDER",
"StartMarketingDate": "20130401",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Attix Pharmaceuticals",
"SubstanceName": "AMBROXOL",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "76420-291-10",
"PackageDescription": "10 CAPSULE in 1 CARTON (76420-291-10) ",
"NDC11Code": "76420-0291-10",
"ProductNDC": "76420-291",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oseltamivir Phosphate",
"NonProprietaryName": "Oseltamivir Phosphate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20180223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209438",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "OSELTAMIVIR PHOSPHATE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Neuraminidase Inhibitor [EPC], Neuraminidase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2022-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220923",
"SamplePackage": "N",
"IndicationAndUsage": "Oseltamivir phosphate is an influenza neuraminidase inhibitor (NAI) indicated for: Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. (1.1) Prophylaxis of influenza A and B in patients 1 year and older. (1.2)Limitations of Use: Not a substitute for annual influenza vaccination. (1.3) Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use. (1.3) Not recommended for patients with end-stage renal disease not undergoing dialysis. (1.3).",
"Description": "Oseltamivir phosphate, an influenza neuraminidase inhibitor (NAI), is available as: Capsules containing 30 mg, 45 mg, or 75 mg of oseltamivir for oral use, in the form of oseltamivir phosphate In addition to the active ingredient, each capsule contains croscarmellose sodium, povidone, pregelatinized starch, sodium stearyl fumarate and talc. The 30 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide and red iron oxide. The 45 mg capsule shell contains gelatin, titanium dioxide and black iron oxide. The 75 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide, black iron oxide and red iron oxide. Each capsule is printed with blue ink, which includes shellac, propylene glycol, strong ammonia solution and FD&C Blue No. 2 as the colorant. The botanical source for pregelatinized starch is maize starch. Oseltamivir phosphate USP is a white to off-white powder with the chemical name [3R-(3α,4β,5α)]-Ethyl 4-(acetyl amino)-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylate phosphate (1:1). The molecular formula is C 16H 28N 2O 4.H 3PO 4. The relative molecular mass is 410.40 for oseltamivir phosphate salt. The structural formula is as follows:."
},
{
"NDCCode": "82431-291-10",
"PackageDescription": "1 KIT in 1 CARTON (82431-291-10) * 10 TABLET, CHEWABLE in 1 BOTTLE (82431-201-10) * 10 TABLET, CHEWABLE in 1 BOTTLE (82431-202-10) ",
"NDC11Code": "82431-0291-10",
"ProductNDC": "82431-291",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Wonderbelly Extra Strength Anti-gas",
"NonProprietaryName": "Simethicone",
"DosageFormName": "KIT",
"StartMarketingDate": "20250201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M002",
"LabelerName": "Ginger Health Company",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250201",
"SamplePackage": "N",
"IndicationAndUsage": "relieves: 1 pressure , 2 bloating, 3 fullness commonly referred to as gas ."
},
{
"NDCCode": "0113-0291-26",
"PackageDescription": "1 BOTTLE in 1 CARTON (0113-0291-26) > 118 mL in 1 BOTTLE",
"NDC11Code": "00113-0291-26",
"ProductNDC": "0113-0291",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Good Sense Anti Nausea",
"NonProprietaryName": "Dextrose (glucose), Levulose (fructose), Phosphoric Acid",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19940221",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "L Perrigo Company",
"SubstanceName": "DEXTROSE; FRUCTOSE; PHOSPHORIC ACID",
"StrengthNumber": "1.87; 1.87; 21.5",
"StrengthUnit": "g/5mL; g/5mL; mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2017-11-10"
},
{
"NDCCode": "0316-0291-17",
"PackageDescription": "1 CANISTER in 1 CARTON (0316-0291-17) / 48 g in 1 CANISTER",
"NDC11Code": "00316-0291-17",
"ProductNDC": "0316-0291",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sarna Whipped Foam",
"NonProprietaryName": "Hydrocortisone",
"DosageFormName": "AEROSOL, FOAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210315",
"EndMarketingDate": "20241031",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Crown Laboratories",
"SubstanceName": "HYDROCORTISONE",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210315",
"EndMarketingDatePackage": "20241031",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to: eczema insect bites poison ivy poison oak poison sumac seborrheic dermatitis psoriasis other uses of this product should be only under the advice and supervision of a doctor."
},
{
"NDCCode": "0363-0291-14",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0363-0291-14) ",
"NDC11Code": "00363-0291-14",
"ProductNDC": "0363-0291",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19880524",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075010",
"LabelerName": "Walgreen Company",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-10-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19980524",
"EndMarketingDatePackage": "20270430",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to: toothachethe common coldmenstrual crampsheadacheminor pain of arthritisbackachemuscular aches. temporarily reduces fever."
},
{
"NDCCode": "0363-0291-16",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0363-0291-16) ",
"NDC11Code": "00363-0291-16",
"ProductNDC": "0363-0291",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19880524",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075010",
"LabelerName": "Walgreen Company",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-10-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230525",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to: toothachethe common coldmenstrual crampsheadacheminor pain of arthritisbackachemuscular aches. temporarily reduces fever."
},
{
"NDCCode": "0363-0291-29",
"PackageDescription": "150 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0363-0291-29) ",
"NDC11Code": "00363-0291-29",
"ProductNDC": "0363-0291",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19880524",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075010",
"LabelerName": "Walgreen Company",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-10-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19880524",
"EndMarketingDatePackage": "20280630",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to: toothachethe common coldmenstrual crampsheadacheminor pain of arthritisbackachemuscular aches. temporarily reduces fever."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>0268-0291-10</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (0268-0291-10) </PackageDescription>
<NDC11Code>00268-0291-10</NDC11Code>
<ProductNDC>0268-0291</ProductNDC>
<ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Meadow Fescue Grass, Standardized</ProprietaryName>
<NonProprietaryName>Meadow Fescue Grass, Standardized</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>19971218</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103053</ApplicationNumber>
<LabelerName>ALK-Abello, Inc.</LabelerName>
<SubstanceName>FESTUCA PRATENSIS POLLEN</SubstanceName>
<StrengthNumber>100000</StrengthNumber>
<StrengthUnit>[BAU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-05-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19971218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indicated use of allergenic extracts is for the diagnosis and treatment (hyposensitization therapy) of patients who experience allergic symptoms due to exposure to grass pollen and who exhibit type I skin sensitivity when tested to those specific allergens. Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust mites, molds, animal danders, and various other inhalants in situations where the offending allergen cannot be avoided. For previously untreated patients, prior to the initiation of therapy, clinical sensitivity to the standardized grass pollen extract should be established by careful evaluation of the patient's history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can easily be avoided. 10,000 BAU/mL extracts are indicated for percutaneous testing. If negative, the 100,000 BAU/mL dose may be used. Availability of 10,000 and 100,000 BAU/mL dosages facilitate safe switching. Patients who tolerate dilutions prepared from the 10,000 BAU/mL dosage and require a higher dose may be treated with dilutions prepared from the 100,000 BAU/mL dosage. 100,000 BAU/mL concentrations may be especially useful when patients are hyposensitized to numerous allergens. Mixing of allergenic extracts dilutes the potency of each constituent. Using higher concentrations such as 100,000 BAU/mL allows for dilution with other extracts without sacrificing immunizing properties. CAUTION: The final potency of each individual component in a patient mixture should never exceed 10,000 BAU/mL. See also, DOSAGE AND ADMINISTRATION section for discussion of mixture labeling.</IndicationAndUsage>
<Description>Standardized allergenic extract of grass pollens from Timothy (Phleum pratense), Orchard (Dactylis glomerata), June (Poa pratensis), Red Top (Agrostis alba), Sweet Vernal (Anthoxanthum odoratum), Meadow Fescue (Festuca elatior), Perennial Rye (Lolium perenne), Bermuda Grass (Cynodon dactylon), in the accompanying vial are sterile, and contain glycerin 50% v/v and phenol 0.4% (preservative). Inert ingredients may include sodium chloride for isotonicity and sodium bicarbonate buffer. Glycerinated pollen extracts, for subcutaneous injection for immunotherapy and/or percutaneous or intracutaneous testing (see Dosage and Administration section), are prepared from defatted dried pollen extracted in glycerinated Coca’s Fluid, filtered aseptically, and dispensed into multiple dose vials. These are subsequently tested for sterility, safety, and potency. For ease in use and for lot-to-lot consistency, the potency is expressed in Bioequivalent Allergy Units (BAUs) per milliliter. A value of 10,000 BAU/mL is assigned to the CBER reference standard that can be diluted 1:0.5 million to produce intradermal ƩE (sum of Erythema) of 50 mm in highly puncture reactive subjects1. A value of 100,000 BAU/mL is assigned to the CBER reference standard that can be diluted 1:5 million to produce intradermal ƩE (sum of Erythema) of 50 mm in highly puncture reactive subjects. The relative potency of each lot of standardized extract has been compared to the official CBER reference standard by an acceptable assay such as ELISA Inhibition.2 When the potency is equivalent by ELISA Inhibition to the reference, the product is assigned 10,000 BAU/mL or 100,000 BAU/mL. Standardized grass pollen extracts, except for Bermuda, have potency designations of either 10,000 BAU/mL or 100,000 BAU/mL. Bermuda grass pollen extract is only available with a 10,000 BAU/mL potency designation. In the ELISA Inhibition assay, a competitive binding assay, the wells of microtiter plates are coated using a characterized allergenic extract. Allergic sera is added to each well. The binding of IgE specific for the coating allergen is inhibited by concentrations of a test sample of an extract of the same allergen. The amount of IgE bound to the solid phase allergen (and subsequently the degree of inhibition) is determined using enzyme-labeled anti-human IgE antibodies and the appropriate substrate. The potency relative to a reference is determined using a parallel line bioassay method.</Description>
</NDC>
<NDC>
<NDCCode>0268-0291-50</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (0268-0291-50) </PackageDescription>
<NDC11Code>00268-0291-50</NDC11Code>
<ProductNDC>0268-0291</ProductNDC>
<ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Meadow Fescue Grass, Standardized</ProprietaryName>
<NonProprietaryName>Meadow Fescue Grass, Standardized</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>19971218</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103053</ApplicationNumber>
<LabelerName>ALK-Abello, Inc.</LabelerName>
<SubstanceName>FESTUCA PRATENSIS POLLEN</SubstanceName>
<StrengthNumber>100000</StrengthNumber>
<StrengthUnit>[BAU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-05-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19971218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indicated use of allergenic extracts is for the diagnosis and treatment (hyposensitization therapy) of patients who experience allergic symptoms due to exposure to grass pollen and who exhibit type I skin sensitivity when tested to those specific allergens. Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust mites, molds, animal danders, and various other inhalants in situations where the offending allergen cannot be avoided. For previously untreated patients, prior to the initiation of therapy, clinical sensitivity to the standardized grass pollen extract should be established by careful evaluation of the patient's history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can easily be avoided. 10,000 BAU/mL extracts are indicated for percutaneous testing. If negative, the 100,000 BAU/mL dose may be used. Availability of 10,000 and 100,000 BAU/mL dosages facilitate safe switching. Patients who tolerate dilutions prepared from the 10,000 BAU/mL dosage and require a higher dose may be treated with dilutions prepared from the 100,000 BAU/mL dosage. 100,000 BAU/mL concentrations may be especially useful when patients are hyposensitized to numerous allergens. Mixing of allergenic extracts dilutes the potency of each constituent. Using higher concentrations such as 100,000 BAU/mL allows for dilution with other extracts without sacrificing immunizing properties. CAUTION: The final potency of each individual component in a patient mixture should never exceed 10,000 BAU/mL. See also, DOSAGE AND ADMINISTRATION section for discussion of mixture labeling.</IndicationAndUsage>
<Description>Standardized allergenic extract of grass pollens from Timothy (Phleum pratense), Orchard (Dactylis glomerata), June (Poa pratensis), Red Top (Agrostis alba), Sweet Vernal (Anthoxanthum odoratum), Meadow Fescue (Festuca elatior), Perennial Rye (Lolium perenne), Bermuda Grass (Cynodon dactylon), in the accompanying vial are sterile, and contain glycerin 50% v/v and phenol 0.4% (preservative). Inert ingredients may include sodium chloride for isotonicity and sodium bicarbonate buffer. Glycerinated pollen extracts, for subcutaneous injection for immunotherapy and/or percutaneous or intracutaneous testing (see Dosage and Administration section), are prepared from defatted dried pollen extracted in glycerinated Coca’s Fluid, filtered aseptically, and dispensed into multiple dose vials. These are subsequently tested for sterility, safety, and potency. For ease in use and for lot-to-lot consistency, the potency is expressed in Bioequivalent Allergy Units (BAUs) per milliliter. A value of 10,000 BAU/mL is assigned to the CBER reference standard that can be diluted 1:0.5 million to produce intradermal ƩE (sum of Erythema) of 50 mm in highly puncture reactive subjects1. A value of 100,000 BAU/mL is assigned to the CBER reference standard that can be diluted 1:5 million to produce intradermal ƩE (sum of Erythema) of 50 mm in highly puncture reactive subjects. The relative potency of each lot of standardized extract has been compared to the official CBER reference standard by an acceptable assay such as ELISA Inhibition.2 When the potency is equivalent by ELISA Inhibition to the reference, the product is assigned 10,000 BAU/mL or 100,000 BAU/mL. Standardized grass pollen extracts, except for Bermuda, have potency designations of either 10,000 BAU/mL or 100,000 BAU/mL. Bermuda grass pollen extract is only available with a 10,000 BAU/mL potency designation. In the ELISA Inhibition assay, a competitive binding assay, the wells of microtiter plates are coated using a characterized allergenic extract. Allergic sera is added to each well. The binding of IgE specific for the coating allergen is inhibited by concentrations of a test sample of an extract of the same allergen. The amount of IgE bound to the solid phase allergen (and subsequently the degree of inhibition) is determined using enzyme-labeled anti-human IgE antibodies and the appropriate substrate. The potency relative to a reference is determined using a parallel line bioassay method.</Description>
</NDC>
<NDC>
<NDCCode>0069-0291-10</NDCCode>
<PackageDescription>10 CARTON in 1 CARTON (0069-0291-10) / 1 SYRINGE in 1 CARTON (0069-0291-01) / .5 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>00069-0291-10</NDC11Code>
<ProductNDC>0069-0291</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nivestym</ProprietaryName>
<NonProprietaryName>Filgrastim-aafi</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20180924</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761080</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>FILGRASTIM</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>ug/.5mL</StrengthUnit>
<Pharm_Classes>Granulocyte Colony-Stimulating Factor [CS], Increased Myeloid Cell Production [PE], Leukocyte Growth Factor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180924</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NIVESTYM is a leukocyte growth factor indicated to: 1 Decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever. (1.1), 2 Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML). (1.2), 3 Reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT). (1.3), 4 Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis. (1.4), 5 Reduce the incidence and duration of sequelae of severe neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia. (1.5).</IndicationAndUsage>
<Description>Filgrastim-aafi is a 175 amino acid human granulocyte colony-stimulating factor (G-CSF) manufactured by recombinant DNA technology. NIVESTYM is produced by Escherichia coli (E coli) bacteria into which has been inserted the human granulocyte colony-stimulating factor gene. NIVESTYM has a molecular weight of 18‚799 daltons. The protein has an amino acid sequence that is identical to the natural sequence predicted from human DNA sequence analysis‚ except for the addition of an N-terminal methionine necessary for expression in E coli. Because NIVESTYM is produced in E coli‚ the product is non-glycosylated and thus differs from G-CSF isolated from a human cell. NIVESTYM is a sterile‚ clear‚ colorless‚ preservative-free liquid containing filgrastim-aafi injection for subcutaneous or intravenous use. The product is available in single-dose vials for subcutaneous or intravenous use and prefilled syringes for subcutaneous use. The single-dose vials contain either 300 mcg/mL or 480 mcg/1.6 mL of filgrastim-aafi. The single-dose prefilled syringes contain either 300 mcg/0.5 mL or 480 mcg/0.8 mL of filgrastim-aafi. The final pH range of the NIVESTYM drug product solution is 3.8 to 4.3. See Table 4 below for product composition of each single-dose vial or prefilled syringe.</Description>
</NDC>
<NDC>
<NDCCode>0363-0291-03</NDCCode>
<PackageDescription>10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0363-0291-03) </PackageDescription>
<NDC11Code>00363-0291-03</NDC11Code>
<ProductNDC>0363-0291</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19880524</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075010</ApplicationNumber>
<LabelerName>Walgreen Company</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>200</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>2026-10-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19880524</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to: toothachethe common coldmenstrual crampsheadacheminor pain of arthritisbackachemuscular aches. temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>21749-291-10</NDCCode>
<PackageDescription>1000 mL in 1 BAG (21749-291-10) </PackageDescription>
<NDC11Code>21749-0291-10</NDC11Code>
<ProductNDC>21749-291</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Signatry Ultra Antimicrobial Ltn Sp</ProprietaryName>
<NonProprietaryName>Chloroxylenol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20010919</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>GOJO Industries, Inc.</LabelerName>
<SubstanceName>CHLOROXYLENOL</SubstanceName>
<StrengthNumber>.003</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20010919</StartMarketingDatePackage>
<EndMarketingDatePackage>20231231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> Handwash to help decrease bacteria on the skin. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>27241-291-10</NDCCode>
<PackageDescription>1000 CAPSULE in 1 BOTTLE (27241-291-10) </PackageDescription>
<NDC11Code>27241-0291-10</NDC11Code>
<ProductNDC>27241-291</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Terazosin</ProprietaryName>
<NonProprietaryName>Terazosin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250512</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219482</ApplicationNumber>
<LabelerName>Ajanta Pharma USA Inc.</LabelerName>
<SubstanceName>TERAZOSIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250512</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Terazosin capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH). There is a rapid response, with approximately 70% of patients experiencing an increase in urinary flow and improvement in symptoms of BPH when treated with terazosin capsules. The long-term effects of terazosin capsules on the incidence of surgery, acute urinary obstruction or other complications of BPH are yet to be determined. Terazosin capsules are also indicated for the treatment of hypertension. Terazosin capsules can be used alone or in combination with other antihypertensive agents such as diuretics or beta-adrenergic blocking agents.</IndicationAndUsage>
<Description>Terazosin hydrochloride USP, an alpha-1-selective adrenoceptor blocking agent, is a quinazoline derivative represented by the following chemical name, molecular formula and structural formula. Piperazine, 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-[(tetrahydro-2-furanyl)carbonyl]-, monohydrochloride, dihydrate. C19H25N5O4 HCl 2H2O. Terazosin hydrochloride, USP is a white to pale yellow, crystalline powder. Soluble in methanol, sparingly soluble in water, slightly soluble in alcohol and in 0.1 N hydrochloric acid, very slightly soluble in isotonic saline solution and in chloroform and practically insoluble in acetone and in hexanes and has a molecular weight of 459.93. Each capsule, for oral administration, contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and pregelatinized starch. The gelatin capsule contains gelatin, sodium lauryl sulfate, and titanium dioxide. The 1 mg shell also contains ferric oxide black; the 2 mg capsule shell also contains D&C Yellow-10; the 5 mg capsule shell also contains D&C Yellow-10, D&C Red-28 and FD&C Red-40; the 10 mg capsule shell also contains D&C Yellow-10 and FD&C Green-3. Imprinting ink contains shellac, propylene glycol, butyl alcohol, potassium hydroxide and black iron oxide. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>31722-291-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (31722-291-10) </PackageDescription>
<NDC11Code>31722-0291-10</NDC11Code>
<ProductNDC>31722-291</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levothyroxine Sodium</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230118</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215259</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>.137</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230118</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypothyroidism. Levothyroxine sodium tablets are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression. Levothyroxine sodium tablets are indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: : 1 Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium tablets may induce hyperthyroidism [see Warnings and Precautions (5.4)]. , 2 Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.</IndicationAndUsage>
<Description>Levothyroxine sodium tablets, USP contain synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt. Synthetic T4 is identical in chemical structure to the T4 produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4NNaO4 xH2O, molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown. Levothyroxine sodium tablets for oral administration are available in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients butylated hydroxyanisole, microcrystalline cellulose, sodium starch glycolate, povidone, colloidal silicon dioxide, magnesium stearate and color additive(s). Table 6 provides a listing of the color additives by tablet strength. FDA approved Dissolution test differs from the USP dissolution test. FDA approved Assay test differs from the USP assay test.</Description>
</NDC>
<NDC>
<NDCCode>46708-291-10</NDCCode>
<PackageDescription>100 TABLET in 1 CARTON (46708-291-10) </PackageDescription>
<NDC11Code>46708-0291-10</NDC11Code>
<ProductNDC>46708-291</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Tartrate</ProprietaryName>
<NonProprietaryName>Metoprolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130722</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202871</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-05-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130722</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypertension Metoprolol tartrate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents. Angina Pectoris Metoprolol tartrate tablets are indicated in the long-term treatment of angina pectoris. Myocardial Infarction. Metoprolol tartrate tablets are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality when used alone or in conjunction with intravenous metoprolol. Oral metoprolol therapy can be initiated after intravenous metoprolol therapy or, alternatively, oral treatment can begin within 3 to 10 days of the acute event (see DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, and WARNINGS.</IndicationAndUsage>
<Description>Metoprolol tartrate, USP is a selective beta1-adrenoreceptor blocking agent, available as 25 mg, 50 mg and 100 mg tablets for oral administration. Metoprolol tartrate USP is (±)-1-(Isopropylamino)-3-[p-2-methoxyethyl)phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Each tablet for oral administration contains 25 mg, 50 mg or 100 mg of metoprolol tartrate and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, povidone, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate hypromellose, titanium dioxide and polyethylene glycol. In addition, the 50 mg product contains D&C Red No. 30 Aluminum Lake and the 100 mg product contains FD&C Blue No. 2 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake as coloring agents.</Description>
</NDC>
<NDC>
<NDCCode>47285-291-10</NDCCode>
<PackageDescription>145340 L in 1 DEWAR (47285-291-10) </PackageDescription>
<NDC11Code>47285-0291-10</NDC11Code>
<ProductNDC>47285-291</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxygen</ProprietaryName>
<NonProprietaryName>Oxygen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19410101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205767</ApplicationNumber>
<LabelerName>James C. Dawes Company, Inc</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>99</StrengthNumber>
<StrengthUnit>L/100L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-03-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19410101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49281-291-10</NDCCode>
<PackageDescription>10 SYRINGE, GLASS in 1 PACKAGE (49281-291-10) > .5 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>49281-0291-10</NDC11Code>
<ProductNDC>49281-291</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Decavac</ProprietaryName>
<NonProprietaryName>Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated) And Corynebacterium Diphtheriae Toxoid Antigen (formaldehyde Inactivated)</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20040324</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103921</ApplicationNumber>
<LabelerName>Sanofi Pasteur Inc.</LabelerName>
<SubstanceName>CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
<StrengthNumber>5; 2</StrengthNumber>
<StrengthUnit>[Lf]/.5mL; [Lf]/.5mL</StrengthUnit>
<Pharm_Classes>Inactivated Clostridium Tetani Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Tetanus Toxoid [Chemical/Ingredient],Inactivated Corynebacterium Diphtheriae Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Diphtheria Toxoid [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>49288-0291-3</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (49288-0291-3)</PackageDescription>
<NDC11Code>49288-0291-03</NDC11Code>
<ProductNDC>49288-0291</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Lobster</ProprietaryName>
<NonProprietaryName>Lobster</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>LOBSTER</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Shellfish Proteins [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. 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%. 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 or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
</NDC>
<NDC>
<NDCCode>50844-291-10</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (50844-291-10) / 40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>50844-0291-10</NDC11Code>
<ProductNDC>50844-291</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19880524</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075010</ApplicationNumber>
<LabelerName>L.N.K. International, Inc.</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>200</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>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19880524</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to:headachetoothachebackachemenstrual crampsthe common coldmuscular achesminor pain of arthritis. temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>52817-291-10</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (52817-291-10) </PackageDescription>
<NDC11Code>52817-0291-10</NDC11Code>
<ProductNDC>52817-291</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxazepam</ProprietaryName>
<NonProprietaryName>Oxazepam</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071026</ApplicationNumber>
<LabelerName>TruPharma, LLC</LabelerName>
<SubstanceName>OXAZEPAM</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Oxazepam, USP is the first of a chemical series of compounds known as the 3- hydroxybenzodiazepinones. A therapeutic agent providing versatility and flexibility in control of common emotional disturbances, this product exerts prompt action in a wide variety of disorders associated with anxiety, tension, agitation, and irritability, and anxiety associated with depression. In tolerance and toxicity studies on several animal species, this product reveals significantly greater safety factors than related compounds (chlordiazepoxide and diazepam) and manifests a wide separation of effective doses and doses inducing side effects. Oxazepam, is 7-chloro-1,3-dihydro-3-hydroxy-5-phenyl-2 H-1,4-benzodiazepin-2-one and has the following structural formula:. MW 286.72. Oxazepam is a white-crystalline powder. Each capsule for oral administration contain 10 mg, 15 mg or 30 mg of oxazepam. Inactive ingredients: croscarmellose sodium, D&C yellow #10, FD&C blue #1, FD&C blue # 2, FD&C red # 40, ferric oxide black, gelatin, lactose monohydrate, magnesium stearate, microcrystalline cellulose, n-butyl alcohol, propylene glycol, sda-3a alcohol, shellac, sodium lauryl sulfate, titanium dioxide and other inert ingredients. The 15 mg capsule also contains: FD&C yellow # 6. The 30 mg capsule also contains: D&C red # 28.</Description>
</NDC>
<NDC>
<NDCCode>54575-291-10</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (54575-291-10)</PackageDescription>
<NDC11Code>54575-0291-10</NDC11Code>
<ProductNDC>54575-291</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dog Hair And Epithelia</ProprietaryName>
<NonProprietaryName>Canis Lupus Familiaris Hair And Canis Lupus Familiaris Skin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19671207</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101376</ApplicationNumber>
<LabelerName>Allergy Laboratories, Inc.</LabelerName>
<SubstanceName>CANIS LUPUS FAMILIARIS HAIR; CANIS LUPUS FAMILIARIS SKIN</SubstanceName>
<StrengthNumber>1; 1</StrengthNumber>
<StrengthUnit>g/20mL; g/20mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Animal Fur [CS],Allergens [CS],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
<Description>Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract. The following allergenic extracts are designated and labeled “FOR DIAGNOSTIC USE ONLY”. Data to support the therapeutic use of these extracts has not been established: Coffee Cottonseed Flaxseed Housefly Mosquito. The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens.</Description>
</NDC>
<NDC>
<NDCCode>59779-291-10</NDCCode>
<PackageDescription>1 BOTTLE in 1 PACKAGE (59779-291-10) / 10 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>59779-0291-10</NDC11Code>
<ProductNDC>59779-291</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19880524</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075010</ApplicationNumber>
<LabelerName>CVS Pharmacy</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>200</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>2026-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19880524</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to:. toothache. backache. headache. muscular aches. menstrual cramps. the common cold. minor pain of arthritis. temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62802-291-10</NDCCode>
<PackageDescription>295 g in 1 CAN (62802-291-10)</PackageDescription>
<NDC11Code>62802-0291-10</NDC11Code>
<ProductNDC>62802-291</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>No-ad Kids Spf50 Continuous Mist Sunscreen</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Oxybenzone, Octocrylene</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Sun & Skin Care Research, LLC</LabelerName>
<SubstanceName>HOMOSALATE; OCTISALATE; OXYBENZONE; OCTOCRYLENE; AVOBENZONE</SubstanceName>
<StrengthNumber>10; 5; 5; 2; 2</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g; g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>helps prevent sunburn. If used as directed with other skin protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>64720-291-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (64720-291-10) </PackageDescription>
<NDC11Code>64720-0291-10</NDC11Code>
<ProductNDC>64720-291</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glyburide</ProprietaryName>
<NonProprietaryName>Glyburide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160601</StartMarketingDate>
<EndMarketingDate>20190201</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206079</ApplicationNumber>
<LabelerName>CorePharma, LLC</LabelerName>
<SubstanceName>GLYBURIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfonylurea [EPC],Sulfonylurea Compounds [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160601</StartMarketingDatePackage>
<EndMarketingDatePackage>20190201</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>67877-291-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (67877-291-10) </PackageDescription>
<NDC11Code>67877-0291-10</NDC11Code>
<ProductNDC>67877-291</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydralazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091124</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200737</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>HYDRALAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2018-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091124</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Essential hypertension, alone or as an adjunct.</IndicationAndUsage>
<Description>HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. C8H8N4 HClHydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg HydrALAZINE hydrochloride, USP. Tablets also contain microcrystalline cellulose, sodium starch glycolate, stearic acid, povidone K-30, colloidal silicon dioxide, mannitol and FD&C Yellow No 6.</Description>
</NDC>
<NDC>
<NDCCode>69315-291-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (69315-291-10) </PackageDescription>
<NDC11Code>69315-0291-10</NDC11Code>
<ProductNDC>69315-291</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Allopurinol</ProprietaryName>
<NonProprietaryName>Allopurinol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214443</ApplicationNumber>
<LabelerName>Leading Pharma, LLC</LabelerName>
<SubstanceName>ALLOPURINOL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-09-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Allopurinol tablets are indicated for: 1 The management of adults with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy), 2 The management of adult and pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels, 3 The management of adult patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients, despite lifestyle changes (such as reduction of dietary sodium, non-dairy animal protein, oxylate rich foods, refined sugars and increases in oral fluids and fruits and vegetables).</IndicationAndUsage>
<Description>Allopurinol is a xanthine oxidase inhibitor. It has the following structural formula. Allopurinol is known chemically as 1, 5-dihydro-4H-pyrazolo [3, 4-d]pyrimidin-4-one. and it has a molecular weight of 136.11 g/mol. Its solubility in water at 37°C is 80.0 mg/dL and is greater in an alkaline solution. It is a xanthine oxidase inhibitor which is administered orally. Each scored white to off white round tablet contains 100 mg allopurinol and the inactive ingredients crospovidone, colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch, and povidone. Each scored white to off white round tablet contains 200 mg allopurinol and the inactive ingredients crospovidone, colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch, and povidone. Each scored peach round tablet contains 300 mg allopurinol and the inactive ingredients crospovidone, colloidal silicon dioxide, FD&C Yellow No. 6 Lake, lactose monohydrate, magnesium stearate, pregelatinized starch and povidone.</Description>
</NDC>
<NDC>
<NDCCode>69543-291-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (69543-291-10) </PackageDescription>
<NDC11Code>69543-0291-10</NDC11Code>
<ProductNDC>69543-291</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Albuterol</ProprietaryName>
<NonProprietaryName>Albuterol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181027</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211397</ApplicationNumber>
<LabelerName>Virtus Pharmaceuticals LLC</LabelerName>
<SubstanceName>ALBUTEROL SULFATE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181027</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Albuterol tablets are indicated for the relief of bronchospasm in adults and children 6 years of age and older with reversible obstructive airway disease.</IndicationAndUsage>
<Description>Albuterol tablets contain albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta2-adrenergic bronchodilator. Albuterol sulfate has the chemical name α1-[(tert-Butylamino)methyl]-4-hydroxy-m-xylene-α,α'-diol sulfate (2:1) (salt) and the following structural formula. Albuterol sulfate has a molecular weight of 576.7, and the molecular formula is (C13H21NO3)2H2SO4. Albuterol sulfate is a white or practically white powder, freely soluble in water and slightly soluble in alcohol, chloroform and ether. The World Health Organization recommended name for albuterol base is salbutamol. Each albuterol sulfate tablet, for oral administration contains 2 or 4 mg of albuterol as 2.4 or 4.8 mg of albuterol sulfate, respectively. Each tablet also contains the following inactive ingredients: lactose anhydrous, magnesium stearate, pregelatinized starch, and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>71335-0291-6</NDCCode>
<PackageDescription>10 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0291-6) </PackageDescription>
<NDC11Code>71335-0291-06</NDC11Code>
<ProductNDC>71335-0291</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole Sodium</ProprietaryName>
<NonProprietaryName>Pantoprazole</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160620</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205119</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220628</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pantoprazole sodium delayed-release tablets are indicated for.</IndicationAndUsage>
<Description>The active ingredient in pantoprazole sodium delayed-release tablets USP, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S x 1.5 H2O, with a molecular weight of 432.4. The structural formula is. Pantoprazole sodium, USP sesquihydrate is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium, USP sesquihydrate is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole sodium, USP is supplied as a delayed-release tablet, available in two strengths (20 mg and 40 mg). Each pantoprazole sodium delayed-release tablet, USP contains 45.1 mg or 22.56 mg of pantoprazole sodium, USP sesquihydrate (equivalent to 40 mg or 20 mg pantoprazole, respectively). Pantoprazole sodium delayed-release tablets, USP contains the following inactive ingredients: ammonium hydroxide, crospovidone, hydroxyl propyl cellulose, hypromellose, iron oxide black, iron oxide yellow, mannitol, methacrylic acid copolymer dispersion, polyethylene glycol, polyvinyl alcohol, povidone, propylene glycol, shellac, sodium carbonate, sodium hydroxide, sodium stearyl fumarate, talc, titanium dioxide and triethyl citrate. Pantoprazole sodium delayed-release tablets, USP (40 mg and 20 mg) complies with USP dissolution test 2.</Description>
</NDC>
<NDC>
<NDCCode>71919-291-10</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE, GLASS (71919-291-10) </PackageDescription>
<NDC11Code>71919-0291-10</NDC11Code>
<ProductNDC>71919-291</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ferrum Phosphoricum</ProprietaryName>
<NonProprietaryName>Ferrosoferric Phosphate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100319</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>FERROSOFERRIC PHOSPHATE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100319</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>75839-291-10</NDCCode>
<PackageDescription>1 kg in 1 BOTTLE (75839-291-10)</PackageDescription>
<NDC11Code>75839-0291-10</NDC11Code>
<ProductNDC>75839-291</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Ambroxol</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20130401</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Attix Pharmaceuticals</LabelerName>
<SubstanceName>AMBROXOL</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>76420-291-10</NDCCode>
<PackageDescription>10 CAPSULE in 1 CARTON (76420-291-10) </PackageDescription>
<NDC11Code>76420-0291-10</NDC11Code>
<ProductNDC>76420-291</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oseltamivir Phosphate</ProprietaryName>
<NonProprietaryName>Oseltamivir Phosphate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209438</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>OSELTAMIVIR PHOSPHATE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Neuraminidase Inhibitor [EPC], Neuraminidase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220923</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oseltamivir phosphate is an influenza neuraminidase inhibitor (NAI) indicated for: Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. (1.1) Prophylaxis of influenza A and B in patients 1 year and older. (1.2)Limitations of Use: Not a substitute for annual influenza vaccination. (1.3) Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use. (1.3) Not recommended for patients with end-stage renal disease not undergoing dialysis. (1.3).</IndicationAndUsage>
<Description>Oseltamivir phosphate, an influenza neuraminidase inhibitor (NAI), is available as: Capsules containing 30 mg, 45 mg, or 75 mg of oseltamivir for oral use, in the form of oseltamivir phosphate In addition to the active ingredient, each capsule contains croscarmellose sodium, povidone, pregelatinized starch, sodium stearyl fumarate and talc. The 30 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide and red iron oxide. The 45 mg capsule shell contains gelatin, titanium dioxide and black iron oxide. The 75 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide, black iron oxide and red iron oxide. Each capsule is printed with blue ink, which includes shellac, propylene glycol, strong ammonia solution and FD&C Blue No. 2 as the colorant. The botanical source for pregelatinized starch is maize starch. Oseltamivir phosphate USP is a white to off-white powder with the chemical name [3R-(3α,4β,5α)]-Ethyl 4-(acetyl amino)-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylate phosphate (1:1). The molecular formula is C 16H 28N 2O 4.H 3PO 4. The relative molecular mass is 410.40 for oseltamivir phosphate salt. The structural formula is as follows:.</Description>
</NDC>
<NDC>
<NDCCode>82431-291-10</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (82431-291-10) * 10 TABLET, CHEWABLE in 1 BOTTLE (82431-201-10) * 10 TABLET, CHEWABLE in 1 BOTTLE (82431-202-10) </PackageDescription>
<NDC11Code>82431-0291-10</NDC11Code>
<ProductNDC>82431-291</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Wonderbelly Extra Strength Anti-gas</ProprietaryName>
<NonProprietaryName>Simethicone</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20250201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M002</ApplicationNumber>
<LabelerName>Ginger Health Company</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves: 1 pressure , 2 bloating, 3 fullness commonly referred to as gas .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0113-0291-26</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0113-0291-26) > 118 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>00113-0291-26</NDC11Code>
<ProductNDC>0113-0291</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Good Sense Anti Nausea</ProprietaryName>
<NonProprietaryName>Dextrose (glucose), Levulose (fructose), Phosphoric Acid</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19940221</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>L Perrigo Company</LabelerName>
<SubstanceName>DEXTROSE; FRUCTOSE; PHOSPHORIC ACID</SubstanceName>
<StrengthNumber>1.87; 1.87; 21.5</StrengthNumber>
<StrengthUnit>g/5mL; g/5mL; mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-11-10</LastUpdate>
</NDC>
<NDC>
<NDCCode>0316-0291-17</NDCCode>
<PackageDescription>1 CANISTER in 1 CARTON (0316-0291-17) / 48 g in 1 CANISTER</PackageDescription>
<NDC11Code>00316-0291-17</NDC11Code>
<ProductNDC>0316-0291</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sarna Whipped Foam</ProprietaryName>
<NonProprietaryName>Hydrocortisone</NonProprietaryName>
<DosageFormName>AEROSOL, FOAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210315</StartMarketingDate>
<EndMarketingDate>20241031</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Crown Laboratories</LabelerName>
<SubstanceName>HYDROCORTISONE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210315</StartMarketingDatePackage>
<EndMarketingDatePackage>20241031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to: eczema insect bites poison ivy poison oak poison sumac seborrheic dermatitis psoriasis other uses of this product should be only under the advice and supervision of a doctor.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0363-0291-14</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0363-0291-14) </PackageDescription>
<NDC11Code>00363-0291-14</NDC11Code>
<ProductNDC>0363-0291</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19880524</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075010</ApplicationNumber>
<LabelerName>Walgreen Company</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>200</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>2026-10-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980524</StartMarketingDatePackage>
<EndMarketingDatePackage>20270430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to: toothachethe common coldmenstrual crampsheadacheminor pain of arthritisbackachemuscular aches. temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0363-0291-16</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0363-0291-16) </PackageDescription>
<NDC11Code>00363-0291-16</NDC11Code>
<ProductNDC>0363-0291</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19880524</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075010</ApplicationNumber>
<LabelerName>Walgreen Company</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>200</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>2026-10-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230525</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to: toothachethe common coldmenstrual crampsheadacheminor pain of arthritisbackachemuscular aches. temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0363-0291-29</NDCCode>
<PackageDescription>150 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0363-0291-29) </PackageDescription>
<NDC11Code>00363-0291-29</NDC11Code>
<ProductNDC>0363-0291</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19880524</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075010</ApplicationNumber>
<LabelerName>Walgreen Company</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>200</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>2026-10-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19880524</StartMarketingDatePackage>
<EndMarketingDatePackage>20280630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to: toothachethe common coldmenstrual crampsheadacheminor pain of arthritisbackachemuscular aches. temporarily reduces fever.</IndicationAndUsage>
</NDC>
</NDCList>