{
"NDC": [
{
"NDCCode": "65044-0832-2",
"PackageDescription": "10 mL in 1 VIAL (65044-0832-2) ",
"NDC11Code": "65044-0832-02",
"ProductNDC": "65044-0832",
"ProductTypeName": "STANDARDIZED ALLERGENIC",
"ProprietaryName": "Standardized Grass Pollen, Timothy",
"NonProprietaryName": "Standardized Grass Pollen, Timothy",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19980115",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103879",
"LabelerName": "Jubilant HollisterStier LLC",
"SubstanceName": "PHLEUM PRATENSE 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": "2026-03-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19980115",
"SamplePackage": "N",
"IndicationAndUsage": "Standardized Grass Pollen Extracts [see Description (11)] are indicated for: 1 Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10, 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen.",
"Description": "This prescribing information covers eight Standardized Grass Pollen Extracts. The term 'Standardized Grass Pollen Extracts' as used throughout labeling specifically refers to all eight products listed in the Product Title in Highlights of Prescribing Information. Standardized Grass Pollen Extracts include Standardized Bermuda Grass Pollen (Cynodon dactylon) at 10,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate and 50 % glycerin by volume as a preservative and Standardized Kentucky Blue (June) Grass Pollen (Poa pratensis), Standardized Meadow Fescue Grass Pollen (Festuca elatior), Standardized Orchard Grass Pollen (Dactylis glomerata), Standardized Perennial Rye Grass Pollen (Lolium perenne), Standardized Redtop Grass Pollen (Agrostis alba), Standardized Sweet Vernal Grass Pollen (Anthoxanthum odoratum), and Standardized Timothy Grass Pollen (Phleum pratense) at 100,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate, and 50 % glycerin by volume as a preservative. Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Extracts are administered percutaneously, intradermally and subcutaneously. Standardized Grass Pollen Extracts are clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing.2, 4, 5, 6 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter."
},
{
"NDCCode": "65044-0832-1",
"PackageDescription": "5 mL in 1 VIAL (65044-0832-1) ",
"NDC11Code": "65044-0832-01",
"ProductNDC": "65044-0832",
"ProductTypeName": "STANDARDIZED ALLERGENIC",
"ProprietaryName": "Standardized Grass Pollen, Timothy",
"NonProprietaryName": "Standardized Grass Pollen, Timothy",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19980115",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103879",
"LabelerName": "Jubilant HollisterStier LLC",
"SubstanceName": "PHLEUM PRATENSE 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": "2026-03-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19980115",
"SamplePackage": "N",
"IndicationAndUsage": "Standardized Grass Pollen Extracts [see Description (11)] are indicated for: 1 Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10, 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen.",
"Description": "This prescribing information covers eight Standardized Grass Pollen Extracts. The term 'Standardized Grass Pollen Extracts' as used throughout labeling specifically refers to all eight products listed in the Product Title in Highlights of Prescribing Information. Standardized Grass Pollen Extracts include Standardized Bermuda Grass Pollen (Cynodon dactylon) at 10,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate and 50 % glycerin by volume as a preservative and Standardized Kentucky Blue (June) Grass Pollen (Poa pratensis), Standardized Meadow Fescue Grass Pollen (Festuca elatior), Standardized Orchard Grass Pollen (Dactylis glomerata), Standardized Perennial Rye Grass Pollen (Lolium perenne), Standardized Redtop Grass Pollen (Agrostis alba), Standardized Sweet Vernal Grass Pollen (Anthoxanthum odoratum), and Standardized Timothy Grass Pollen (Phleum pratense) at 100,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate, and 50 % glycerin by volume as a preservative. Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Extracts are administered percutaneously, intradermally and subcutaneously. Standardized Grass Pollen Extracts are clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing.2, 4, 5, 6 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter."
},
{
"NDCCode": "65044-0832-3",
"PackageDescription": "30 mL in 1 VIAL (65044-0832-3) ",
"NDC11Code": "65044-0832-03",
"ProductNDC": "65044-0832",
"ProductTypeName": "STANDARDIZED ALLERGENIC",
"ProprietaryName": "Standardized Grass Pollen, Timothy",
"NonProprietaryName": "Standardized Grass Pollen, Timothy",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19980115",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103879",
"LabelerName": "Jubilant HollisterStier LLC",
"SubstanceName": "PHLEUM PRATENSE 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": "2026-03-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19980115",
"SamplePackage": "N",
"IndicationAndUsage": "Standardized Grass Pollen Extracts [see Description (11)] are indicated for: 1 Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10, 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen.",
"Description": "This prescribing information covers eight Standardized Grass Pollen Extracts. The term 'Standardized Grass Pollen Extracts' as used throughout labeling specifically refers to all eight products listed in the Product Title in Highlights of Prescribing Information. Standardized Grass Pollen Extracts include Standardized Bermuda Grass Pollen (Cynodon dactylon) at 10,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate and 50 % glycerin by volume as a preservative and Standardized Kentucky Blue (June) Grass Pollen (Poa pratensis), Standardized Meadow Fescue Grass Pollen (Festuca elatior), Standardized Orchard Grass Pollen (Dactylis glomerata), Standardized Perennial Rye Grass Pollen (Lolium perenne), Standardized Redtop Grass Pollen (Agrostis alba), Standardized Sweet Vernal Grass Pollen (Anthoxanthum odoratum), and Standardized Timothy Grass Pollen (Phleum pratense) at 100,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate, and 50 % glycerin by volume as a preservative. Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Extracts are administered percutaneously, intradermally and subcutaneously. Standardized Grass Pollen Extracts are clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing.2, 4, 5, 6 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter."
},
{
"NDCCode": "65044-0832-4",
"PackageDescription": "50 mL in 1 VIAL (65044-0832-4) ",
"NDC11Code": "65044-0832-04",
"ProductNDC": "65044-0832",
"ProductTypeName": "STANDARDIZED ALLERGENIC",
"ProprietaryName": "Standardized Grass Pollen, Timothy",
"NonProprietaryName": "Standardized Grass Pollen, Timothy",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19980115",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103879",
"LabelerName": "Jubilant HollisterStier LLC",
"SubstanceName": "PHLEUM PRATENSE 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": "2026-03-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19980115",
"SamplePackage": "N",
"IndicationAndUsage": "Standardized Grass Pollen Extracts [see Description (11)] are indicated for: 1 Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10, 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen.",
"Description": "This prescribing information covers eight Standardized Grass Pollen Extracts. The term 'Standardized Grass Pollen Extracts' as used throughout labeling specifically refers to all eight products listed in the Product Title in Highlights of Prescribing Information. Standardized Grass Pollen Extracts include Standardized Bermuda Grass Pollen (Cynodon dactylon) at 10,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate and 50 % glycerin by volume as a preservative and Standardized Kentucky Blue (June) Grass Pollen (Poa pratensis), Standardized Meadow Fescue Grass Pollen (Festuca elatior), Standardized Orchard Grass Pollen (Dactylis glomerata), Standardized Perennial Rye Grass Pollen (Lolium perenne), Standardized Redtop Grass Pollen (Agrostis alba), Standardized Sweet Vernal Grass Pollen (Anthoxanthum odoratum), and Standardized Timothy Grass Pollen (Phleum pratense) at 100,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate, and 50 % glycerin by volume as a preservative. Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Extracts are administered percutaneously, intradermally and subcutaneously. Standardized Grass Pollen Extracts are clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing.2, 4, 5, 6 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter."
},
{
"NDCCode": "0832-1121-42",
"PackageDescription": "2 BOTTLE, PUMP in 1 CARTON (0832-1121-42) / 60 GEL, METERED in 1 BOTTLE, PUMP (0832-1121-40) ",
"NDC11Code": "00832-1121-42",
"ProductNDC": "0832-1121",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Testosterone",
"NonProprietaryName": "Testosterone",
"DosageFormName": "GEL, METERED",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140616",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA204399",
"LabelerName": "Upsher-Smith Laboratories, LLC",
"SubstanceName": "TESTOSTERONE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2025-07-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140616",
"SamplePackage": "N",
"IndicationAndUsage": "Testosterone gel is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: 1 Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone levels and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range., 2 Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum levels but have gonadotropins in the normal or low range.",
"Description": "Testosterone gel, for topical use is a clear to translucent hydroalcoholic topical gel containing testosterone, an androgen. Testosterone gel provides continuous transdermal delivery of testosterone for 24 hours, following a single application to intact, clean, dry skin of the shoulders and/or upper arms. Testosterone gel is available in unit-dose tubes, unit-dose packets, and a metered-dose pump. One 5-g or two 5-g tubes/packets of testosterone gel contains 50 mg or 100 mg of testosterone, respectively. One pump actuation dispenses 1.25 g of gel, which contains 12.5 mg of testosterone. Four pump actuations or eight pump actuations contain 50 mg or 100 mg of testosterone, respectively. Each metered-dose pump container is capable of dispensing 60 pump actuations. The active pharmacological ingredient in testosterone gel is testosterone. Testosterone USP is a white to practically white crystalline powder chemically described as 17-β hydroxyandrost-4-en-3-one. The structural formula is shown in the following figure. Inactive ingredients in testosterone gel are carbomer copolymer Type B, carbomer homopolymer Type C, diisopropyl adipate, ethyl alcohol, glycerin, methyl laurate, oleyl alcohol, polyethylene glycol, propylene glycol, purified water, and tromethamine."
},
{
"NDCCode": "17856-0832-1",
"PackageDescription": "50 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0832-1) / 30 mL in 1 CUP, UNIT-DOSE (17856-0832-2) ",
"NDC11Code": "17856-0832-01",
"ProductNDC": "17856-0832",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sunmark",
"NonProprietaryName": "Mineral",
"DosageFormName": "OIL",
"RouteName": "ORAL",
"StartMarketingDate": "20190410",
"EndMarketingDate": "20250718",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M",
"LabelerName": "ATLANTIC BIOLOGICALS CORP.",
"SubstanceName": "MINERAL OIL",
"StrengthNumber": "999",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2025-07-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20240520",
"EndMarketingDatePackage": "20250718",
"SamplePackage": "N",
"IndicationAndUsage": "for relief of occasional constipation (irregularity). Generally produces bowel movement in 6 to 8 hours."
},
{
"NDCCode": "37662-0832-2",
"PackageDescription": "500 PELLET in 1 VIAL, GLASS (37662-0832-2) ",
"NDC11Code": "37662-0832-02",
"ProductNDC": "37662-0832",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Euphrasia Officinalis",
"NonProprietaryName": "Euphrasia Officinalis",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220712",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "EUPHRASIA STRICTA",
"StrengthNumber": "10",
"StrengthUnit": "[hp_M]/1",
"Status": "Active",
"LastUpdate": "2022-07-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220712",
"SamplePackage": "N"
},
{
"NDCCode": "49187-0832-2",
"PackageDescription": "35 kg in 1 BAG (49187-0832-2) ",
"NDC11Code": "49187-0832-02",
"ProductNDC": "49187-0832",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Eslicarbazepin Acetate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20111230",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Lonza AG",
"SubstanceName": "ESLICARBAZEPINE ACETATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2025-12-18",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "30-DEC-11"
},
{
"NDCCode": "52372-0832-2",
"PackageDescription": "1 g in 1 CONTAINER (52372-0832-2)",
"NDC11Code": "52372-0832-02",
"ProductNDC": "52372-0832",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Budesonide Micronized",
"DosageFormName": "POWDER",
"StartMarketingDate": "20120101",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Freedom Pharmaceuticals, Inc.",
"SubstanceName": "BUDESONIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "60905-0832-2",
"PackageDescription": "10 mL in 1 BOTTLE, PLASTIC (60905-0832-2) ",
"NDC11Code": "60905-0832-02",
"ProductNDC": "60905-0832",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Teint Couture Everwear 24h Wear Satin Finish Full Coverage And Comfort Broad Spectrum Spf 20 Y207",
"NonProprietaryName": "Octinoxate, Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20191001",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "LVMH FRAGRANCE BRANDS",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
"StrengthNumber": "30; 17.5",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-10-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20191001",
"SamplePackage": "Y",
"IndicationAndUsage": "helps prevent sunburn if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun Directions."
},
{
"NDCCode": "64942-0832-2",
"PackageDescription": "45 g in 1 CONTAINER (64942-0832-2)",
"NDC11Code": "64942-0832-02",
"ProductNDC": "64942-0832",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Degree Women Sheer Powder",
"ProprietaryNameSuffix": "Antiperspirant And Deodorant",
"NonProprietaryName": "Aluminum Zirconium Tetrachlorohydrex Gly",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100101",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part350",
"LabelerName": "Conopco Inc. d/b/a Unilever",
"SubstanceName": "ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY",
"StrengthNumber": "17.8",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "67296-0832-2",
"PackageDescription": "10 TABLET in 1 BOTTLE (67296-0832-2) ",
"NDC11Code": "67296-0832-02",
"ProductNDC": "67296-0832",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20131018",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091393",
"LabelerName": "RedPharm Drug, Inc.",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20131018",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone hydrochloride tablets are an immediate-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain where the use of an opioid analgesic is appropriate.",
"Description": "Oxycodone hydrochloride tablets USP is an opioid analgesic. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. [2df71fa4-figure-01]. The tablets contain the following inactive ingredients: corn starch; lactose monohydrate; microcrystalline cellulose; silicon dioxide; sodium starch glycolate; and stearic acid. The 10 mg tablet also contains D&C Red No. 27 aluminum lake. The 15 mg tablet also contains D&C Yellow No. 10 aluminum lake and FD&C Blue No. 2 aluminum lake. The 20 mg tablet also contains FD&C Blue No. 2 aluminum lake; FD&C Red No. 40 aluminum lake; and FD&C Yellow No. 6 aluminum lake. The 30 mg tablet also contains FD&C Blue No. 2 aluminum lake. The 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg tablets contain the equivalent of 4.5 mg, 9 mg, 13.5 mg, 18 mg, and 27 mg, respectively, of oxycodone free base."
},
{
"NDCCode": "71335-0832-2",
"PackageDescription": "100 TABLET in 1 BOTTLE (71335-0832-2) ",
"NDC11Code": "71335-0832-02",
"ProductNDC": "71335-0832",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propranolol Hydrochloride",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160919",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070178",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20180521",
"SamplePackage": "N"
},
{
"NDCCode": "72303-0832-2",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (72303-0832-2) ",
"NDC11Code": "72303-0832-02",
"ProductNDC": "72303-0832",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Solifenacin Succinate",
"NonProprietaryName": "Solifenacin Succinate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213346",
"LabelerName": "HEC Pharm USA Inc.",
"SubstanceName": "SOLIFENACIN SUCCINATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260701",
"SamplePackage": "N",
"IndicationAndUsage": "Solifenacin succinate is indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.",
"Description": "Solifenacin succinate is a muscarinic receptor antagonist. Chemically, solifenacin succinate is a butanedioic acid compound with (1 S)-(3 R)-1-azabicyclo[2.2.2]oct-3-yl 3,4-dihydro-1-phenyl-2(1 H)-iso-quinolinecarboxylate (1:1) having an empirical formula of C 23H 26N 2O 2C 4H 6O 4, and a molecular weight of 480.55. The structural formula of solifenacin succinate is:. Solifenacin succinate is a white to pale-yellowish-white crystal or crystalline powder. It is freely soluble at room temperature in water, glacial acetic acid, dimethyl sulfoxide, and methanol. Each solifenacin succinate tablet contains 5 or 10 mg of solifenacin succinate and is for oral administration. In addition to the active ingredient solifenacin succinate, each solifenacin succinate tablet also contains the following inactive ingredients: hypromellose, lactose anhydrous, magnesium stearate, silicified microcrystalline cellulose, lactose monohydrate, titanium dioxide and triacetin."
},
{
"NDCCode": "65044-0537-2",
"PackageDescription": "10 mL in 1 VIAL (65044-0537-2) ",
"NDC11Code": "65044-0537-02",
"ProductNDC": "65044-0537",
"ProductTypeName": "STANDARDIZED ALLERGENIC",
"ProprietaryName": "Standardized Grass Pollen, Bermuda Grass",
"NonProprietaryName": "Standardized Grass Pollen, Bermuda Grass",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19980115",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103872",
"LabelerName": "Jubilant HollisterStier LLC",
"SubstanceName": "CYNODON DACTYLON POLLEN",
"StrengthNumber": "10000",
"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": "2026-03-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19980115",
"SamplePackage": "N",
"IndicationAndUsage": "Standardized Grass Pollen Extracts [see Description (11)] are indicated for: 1 Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10, 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen.",
"Description": "This prescribing information covers eight Standardized Grass Pollen Extracts. The term 'Standardized Grass Pollen Extracts' as used throughout labeling specifically refers to all eight products listed in the Product Title in Highlights of Prescribing Information. Standardized Grass Pollen Extracts include Standardized Bermuda Grass Pollen (Cynodon dactylon) at 10,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate and 50 % glycerin by volume as a preservative and Standardized Kentucky Blue (June) Grass Pollen (Poa pratensis), Standardized Meadow Fescue Grass Pollen (Festuca elatior), Standardized Orchard Grass Pollen (Dactylis glomerata), Standardized Perennial Rye Grass Pollen (Lolium perenne), Standardized Redtop Grass Pollen (Agrostis alba), Standardized Sweet Vernal Grass Pollen (Anthoxanthum odoratum), and Standardized Timothy Grass Pollen (Phleum pratense) at 100,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate, and 50 % glycerin by volume as a preservative. Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Extracts are administered percutaneously, intradermally and subcutaneously. Standardized Grass Pollen Extracts are clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing.2, 4, 5, 6 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter."
},
{
"NDCCode": "65044-0545-2",
"PackageDescription": "10 mL in 1 VIAL (65044-0545-2) ",
"NDC11Code": "65044-0545-02",
"ProductNDC": "65044-0545",
"ProductTypeName": "STANDARDIZED ALLERGENIC",
"ProprietaryName": "Standardized Grass Pollen, Bluegrass, Kentucky June",
"NonProprietaryName": "Standardized Grass Pollen, Bluegrass, Kentucky June",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19980115",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103873",
"LabelerName": "Jubilant HollisterStier LLC",
"SubstanceName": "POA PRATENSIS POLLEN",
"StrengthNumber": "10000",
"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": "2026-03-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19980115",
"SamplePackage": "N",
"IndicationAndUsage": "Standardized Grass Pollen Extracts [see Description (11)] are indicated for: 1 Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10, 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen.",
"Description": "This prescribing information covers eight Standardized Grass Pollen Extracts. The term 'Standardized Grass Pollen Extracts' as used throughout labeling specifically refers to all eight products listed in the Product Title in Highlights of Prescribing Information. Standardized Grass Pollen Extracts include Standardized Bermuda Grass Pollen (Cynodon dactylon) at 10,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate and 50 % glycerin by volume as a preservative and Standardized Kentucky Blue (June) Grass Pollen (Poa pratensis), Standardized Meadow Fescue Grass Pollen (Festuca elatior), Standardized Orchard Grass Pollen (Dactylis glomerata), Standardized Perennial Rye Grass Pollen (Lolium perenne), Standardized Redtop Grass Pollen (Agrostis alba), Standardized Sweet Vernal Grass Pollen (Anthoxanthum odoratum), and Standardized Timothy Grass Pollen (Phleum pratense) at 100,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate, and 50 % glycerin by volume as a preservative. Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Extracts are administered percutaneously, intradermally and subcutaneously. Standardized Grass Pollen Extracts are clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing.2, 4, 5, 6 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter."
},
{
"NDCCode": "65044-0546-2",
"PackageDescription": "10 mL in 1 VIAL (65044-0546-2) ",
"NDC11Code": "65044-0546-02",
"ProductNDC": "65044-0546",
"ProductTypeName": "STANDARDIZED ALLERGENIC",
"ProprietaryName": "Standardized Grass Pollen, Bluegrass, Kentucky June",
"NonProprietaryName": "Standardized Grass Pollen, Bluegrass, Kentucky June",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19980115",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103873",
"LabelerName": "Jubilant HollisterStier LLC",
"SubstanceName": "POA 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": "2026-03-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19980115",
"SamplePackage": "N",
"IndicationAndUsage": "Standardized Grass Pollen Extracts [see Description (11)] are indicated for: 1 Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10, 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen.",
"Description": "This prescribing information covers eight Standardized Grass Pollen Extracts. The term 'Standardized Grass Pollen Extracts' as used throughout labeling specifically refers to all eight products listed in the Product Title in Highlights of Prescribing Information. Standardized Grass Pollen Extracts include Standardized Bermuda Grass Pollen (Cynodon dactylon) at 10,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate and 50 % glycerin by volume as a preservative and Standardized Kentucky Blue (June) Grass Pollen (Poa pratensis), Standardized Meadow Fescue Grass Pollen (Festuca elatior), Standardized Orchard Grass Pollen (Dactylis glomerata), Standardized Perennial Rye Grass Pollen (Lolium perenne), Standardized Redtop Grass Pollen (Agrostis alba), Standardized Sweet Vernal Grass Pollen (Anthoxanthum odoratum), and Standardized Timothy Grass Pollen (Phleum pratense) at 100,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate, and 50 % glycerin by volume as a preservative. Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Extracts are administered percutaneously, intradermally and subcutaneously. Standardized Grass Pollen Extracts are clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing.2, 4, 5, 6 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter."
},
{
"NDCCode": "65044-0611-2",
"PackageDescription": "10 mL in 1 VIAL (65044-0611-2) ",
"NDC11Code": "65044-0611-02",
"ProductNDC": "65044-0611",
"ProductTypeName": "STANDARDIZED ALLERGENIC",
"ProprietaryName": "Standardized Grass Pollen, Fescue, Meadow",
"NonProprietaryName": "Standardized Grass Pollen, Fescue, Meadow",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19980115",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103874",
"LabelerName": "Jubilant HollisterStier LLC",
"SubstanceName": "LOLIUM PRATENSE POLLEN",
"StrengthNumber": "10000",
"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": "2026-03-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19980115",
"SamplePackage": "N",
"IndicationAndUsage": "Standardized Grass Pollen Extracts [see Description (11)] are indicated for: 1 Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10, 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen.",
"Description": "This prescribing information covers eight Standardized Grass Pollen Extracts. The term 'Standardized Grass Pollen Extracts' as used throughout labeling specifically refers to all eight products listed in the Product Title in Highlights of Prescribing Information. Standardized Grass Pollen Extracts include Standardized Bermuda Grass Pollen (Cynodon dactylon) at 10,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate and 50 % glycerin by volume as a preservative and Standardized Kentucky Blue (June) Grass Pollen (Poa pratensis), Standardized Meadow Fescue Grass Pollen (Festuca elatior), Standardized Orchard Grass Pollen (Dactylis glomerata), Standardized Perennial Rye Grass Pollen (Lolium perenne), Standardized Redtop Grass Pollen (Agrostis alba), Standardized Sweet Vernal Grass Pollen (Anthoxanthum odoratum), and Standardized Timothy Grass Pollen (Phleum pratense) at 100,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate, and 50 % glycerin by volume as a preservative. Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Extracts are administered percutaneously, intradermally and subcutaneously. Standardized Grass Pollen Extracts are clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing.2, 4, 5, 6 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter."
},
{
"NDCCode": "65044-0612-2",
"PackageDescription": "10 mL in 1 VIAL (65044-0612-2) ",
"NDC11Code": "65044-0612-02",
"ProductNDC": "65044-0612",
"ProductTypeName": "STANDARDIZED ALLERGENIC",
"ProprietaryName": "Standardized Grass Pollen, Fescue, Meadow",
"NonProprietaryName": "Standardized Grass Pollen, Fescue, Meadow",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19980115",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103874",
"LabelerName": "Jubilant HollisterStier LLC",
"SubstanceName": "LOLIUM PRATENSE 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": "2026-03-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19980115",
"SamplePackage": "N",
"IndicationAndUsage": "Standardized Grass Pollen Extracts [see Description (11)] are indicated for: 1 Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10, 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen.",
"Description": "This prescribing information covers eight Standardized Grass Pollen Extracts. The term 'Standardized Grass Pollen Extracts' as used throughout labeling specifically refers to all eight products listed in the Product Title in Highlights of Prescribing Information. Standardized Grass Pollen Extracts include Standardized Bermuda Grass Pollen (Cynodon dactylon) at 10,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate and 50 % glycerin by volume as a preservative and Standardized Kentucky Blue (June) Grass Pollen (Poa pratensis), Standardized Meadow Fescue Grass Pollen (Festuca elatior), Standardized Orchard Grass Pollen (Dactylis glomerata), Standardized Perennial Rye Grass Pollen (Lolium perenne), Standardized Redtop Grass Pollen (Agrostis alba), Standardized Sweet Vernal Grass Pollen (Anthoxanthum odoratum), and Standardized Timothy Grass Pollen (Phleum pratense) at 100,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate, and 50 % glycerin by volume as a preservative. Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Extracts are administered percutaneously, intradermally and subcutaneously. Standardized Grass Pollen Extracts are clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing.2, 4, 5, 6 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter."
},
{
"NDCCode": "65044-0718-2",
"PackageDescription": "10 mL in 1 VIAL (65044-0718-2) ",
"NDC11Code": "65044-0718-02",
"ProductNDC": "65044-0718",
"ProductTypeName": "STANDARDIZED ALLERGENIC",
"ProprietaryName": "Standardized Grass Pollen, Orchard Grass",
"NonProprietaryName": "Standardized Grass Pollen, Orchard Grass",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19980115",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103875",
"LabelerName": "Jubilant HollisterStier LLC",
"SubstanceName": "DACTYLIS GLOMERATA POLLEN",
"StrengthNumber": "10000",
"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": "2026-03-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19980115",
"SamplePackage": "N",
"IndicationAndUsage": "Standardized Grass Pollen Extracts [see Description (11)] are indicated for: 1 Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10, 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen.",
"Description": "This prescribing information covers eight Standardized Grass Pollen Extracts. The term 'Standardized Grass Pollen Extracts' as used throughout labeling specifically refers to all eight products listed in the Product Title in Highlights of Prescribing Information. Standardized Grass Pollen Extracts include Standardized Bermuda Grass Pollen (Cynodon dactylon) at 10,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate and 50 % glycerin by volume as a preservative and Standardized Kentucky Blue (June) Grass Pollen (Poa pratensis), Standardized Meadow Fescue Grass Pollen (Festuca elatior), Standardized Orchard Grass Pollen (Dactylis glomerata), Standardized Perennial Rye Grass Pollen (Lolium perenne), Standardized Redtop Grass Pollen (Agrostis alba), Standardized Sweet Vernal Grass Pollen (Anthoxanthum odoratum), and Standardized Timothy Grass Pollen (Phleum pratense) at 100,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate, and 50 % glycerin by volume as a preservative. Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Extracts are administered percutaneously, intradermally and subcutaneously. Standardized Grass Pollen Extracts are clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing.2, 4, 5, 6 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter."
},
{
"NDCCode": "65044-0719-2",
"PackageDescription": "10 mL in 1 VIAL (65044-0719-2) ",
"NDC11Code": "65044-0719-02",
"ProductNDC": "65044-0719",
"ProductTypeName": "STANDARDIZED ALLERGENIC",
"ProprietaryName": "Standardized Grass Pollen, Orchard Grass",
"NonProprietaryName": "Standardized Grass Pollen, Orchard Grass",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19980115",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103875",
"LabelerName": "Jubilant HollisterStier LLC",
"SubstanceName": "DACTYLIS GLOMERATA 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": "2026-03-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19980115",
"SamplePackage": "N",
"IndicationAndUsage": "Standardized Grass Pollen Extracts [see Description (11)] are indicated for: 1 Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10, 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen.",
"Description": "This prescribing information covers eight Standardized Grass Pollen Extracts. The term 'Standardized Grass Pollen Extracts' as used throughout labeling specifically refers to all eight products listed in the Product Title in Highlights of Prescribing Information. Standardized Grass Pollen Extracts include Standardized Bermuda Grass Pollen (Cynodon dactylon) at 10,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate and 50 % glycerin by volume as a preservative and Standardized Kentucky Blue (June) Grass Pollen (Poa pratensis), Standardized Meadow Fescue Grass Pollen (Festuca elatior), Standardized Orchard Grass Pollen (Dactylis glomerata), Standardized Perennial Rye Grass Pollen (Lolium perenne), Standardized Redtop Grass Pollen (Agrostis alba), Standardized Sweet Vernal Grass Pollen (Anthoxanthum odoratum), and Standardized Timothy Grass Pollen (Phleum pratense) at 100,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate, and 50 % glycerin by volume as a preservative. Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Extracts are administered percutaneously, intradermally and subcutaneously. Standardized Grass Pollen Extracts are clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing.2, 4, 5, 6 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter."
},
{
"NDCCode": "65044-0777-2",
"PackageDescription": "10 mL in 1 VIAL (65044-0777-2) ",
"NDC11Code": "65044-0777-02",
"ProductNDC": "65044-0777",
"ProductTypeName": "STANDARDIZED ALLERGENIC",
"ProprietaryName": "Standardized Grass Pollen, Redtop",
"NonProprietaryName": "Standardized Grass Pollen, Redtop",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19980115",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103876",
"LabelerName": "Jubilant HollisterStier LLC",
"SubstanceName": "AGROSTIS GIGANTEA POLLEN",
"StrengthNumber": "10000",
"StrengthUnit": "[BAU]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19980115",
"SamplePackage": "N",
"IndicationAndUsage": "Standardized Grass Pollen Extracts [see Description (11)] are indicated for: 1 Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10, 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen.",
"Description": "This prescribing information covers eight Standardized Grass Pollen Extracts. The term 'Standardized Grass Pollen Extracts' as used throughout labeling specifically refers to all eight products listed in the Product Title in Highlights of Prescribing Information. Standardized Grass Pollen Extracts include Standardized Bermuda Grass Pollen (Cynodon dactylon) at 10,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate and 50 % glycerin by volume as a preservative and Standardized Kentucky Blue (June) Grass Pollen (Poa pratensis), Standardized Meadow Fescue Grass Pollen (Festuca elatior), Standardized Orchard Grass Pollen (Dactylis glomerata), Standardized Perennial Rye Grass Pollen (Lolium perenne), Standardized Redtop Grass Pollen (Agrostis alba), Standardized Sweet Vernal Grass Pollen (Anthoxanthum odoratum), and Standardized Timothy Grass Pollen (Phleum pratense) at 100,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate, and 50 % glycerin by volume as a preservative. Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Extracts are administered percutaneously, intradermally and subcutaneously. Standardized Grass Pollen Extracts are clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing.2, 4, 5, 6 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter."
},
{
"NDCCode": "65044-0778-2",
"PackageDescription": "10 mL in 1 VIAL (65044-0778-2) ",
"NDC11Code": "65044-0778-02",
"ProductNDC": "65044-0778",
"ProductTypeName": "STANDARDIZED ALLERGENIC",
"ProprietaryName": "Standardized Grass Pollen, Redtop",
"NonProprietaryName": "Standardized Grass Pollen, Redtop",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19980115",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103876",
"LabelerName": "Jubilant HollisterStier LLC",
"SubstanceName": "AGROSTIS GIGANTEA POLLEN",
"StrengthNumber": "100000",
"StrengthUnit": "[BAU]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19980115",
"SamplePackage": "N",
"IndicationAndUsage": "Standardized Grass Pollen Extracts [see Description (11)] are indicated for: 1 Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10, 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen.",
"Description": "This prescribing information covers eight Standardized Grass Pollen Extracts. The term 'Standardized Grass Pollen Extracts' as used throughout labeling specifically refers to all eight products listed in the Product Title in Highlights of Prescribing Information. Standardized Grass Pollen Extracts include Standardized Bermuda Grass Pollen (Cynodon dactylon) at 10,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate and 50 % glycerin by volume as a preservative and Standardized Kentucky Blue (June) Grass Pollen (Poa pratensis), Standardized Meadow Fescue Grass Pollen (Festuca elatior), Standardized Orchard Grass Pollen (Dactylis glomerata), Standardized Perennial Rye Grass Pollen (Lolium perenne), Standardized Redtop Grass Pollen (Agrostis alba), Standardized Sweet Vernal Grass Pollen (Anthoxanthum odoratum), and Standardized Timothy Grass Pollen (Phleum pratense) at 100,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate, and 50 % glycerin by volume as a preservative. Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Extracts are administered percutaneously, intradermally and subcutaneously. Standardized Grass Pollen Extracts are clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing.2, 4, 5, 6 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter."
},
{
"NDCCode": "65044-0787-2",
"PackageDescription": "10 mL in 1 VIAL (65044-0787-2) ",
"NDC11Code": "65044-0787-02",
"ProductNDC": "65044-0787",
"ProductTypeName": "STANDARDIZED ALLERGENIC",
"ProprietaryName": "Standardized Grass Pollen, Ryegrass",
"NonProprietaryName": "Standardized Grass Pollen, Ryegrass",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19980115",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103877",
"LabelerName": "Jubilant HollisterStier LLC",
"SubstanceName": "LOLIUM PERENNE POLLEN",
"StrengthNumber": "10000",
"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": "2026-03-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19980115",
"SamplePackage": "N",
"IndicationAndUsage": "Standardized Grass Pollen Extracts [see Description (11)] are indicated for: 1 Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10, 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen.",
"Description": "This prescribing information covers eight Standardized Grass Pollen Extracts. The term 'Standardized Grass Pollen Extracts' as used throughout labeling specifically refers to all eight products listed in the Product Title in Highlights of Prescribing Information. Standardized Grass Pollen Extracts include Standardized Bermuda Grass Pollen (Cynodon dactylon) at 10,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate and 50 % glycerin by volume as a preservative and Standardized Kentucky Blue (June) Grass Pollen (Poa pratensis), Standardized Meadow Fescue Grass Pollen (Festuca elatior), Standardized Orchard Grass Pollen (Dactylis glomerata), Standardized Perennial Rye Grass Pollen (Lolium perenne), Standardized Redtop Grass Pollen (Agrostis alba), Standardized Sweet Vernal Grass Pollen (Anthoxanthum odoratum), and Standardized Timothy Grass Pollen (Phleum pratense) at 100,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate, and 50 % glycerin by volume as a preservative. Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Extracts are administered percutaneously, intradermally and subcutaneously. Standardized Grass Pollen Extracts are clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing.2, 4, 5, 6 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter."
},
{
"NDCCode": "65044-0788-2",
"PackageDescription": "10 mL in 1 VIAL (65044-0788-2) ",
"NDC11Code": "65044-0788-02",
"ProductNDC": "65044-0788",
"ProductTypeName": "STANDARDIZED ALLERGENIC",
"ProprietaryName": "Standardized Grass Pollen, Ryegrass",
"NonProprietaryName": "Standardized Grass Pollen, Ryegrass",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19980115",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103877",
"LabelerName": "Jubilant HollisterStier LLC",
"SubstanceName": "LOLIUM PERENNE 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": "2026-03-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19980115",
"SamplePackage": "N",
"IndicationAndUsage": "Standardized Grass Pollen Extracts [see Description (11)] are indicated for: 1 Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10, 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen.",
"Description": "This prescribing information covers eight Standardized Grass Pollen Extracts. The term 'Standardized Grass Pollen Extracts' as used throughout labeling specifically refers to all eight products listed in the Product Title in Highlights of Prescribing Information. Standardized Grass Pollen Extracts include Standardized Bermuda Grass Pollen (Cynodon dactylon) at 10,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate and 50 % glycerin by volume as a preservative and Standardized Kentucky Blue (June) Grass Pollen (Poa pratensis), Standardized Meadow Fescue Grass Pollen (Festuca elatior), Standardized Orchard Grass Pollen (Dactylis glomerata), Standardized Perennial Rye Grass Pollen (Lolium perenne), Standardized Redtop Grass Pollen (Agrostis alba), Standardized Sweet Vernal Grass Pollen (Anthoxanthum odoratum), and Standardized Timothy Grass Pollen (Phleum pratense) at 100,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate, and 50 % glycerin by volume as a preservative. Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Extracts are administered percutaneously, intradermally and subcutaneously. Standardized Grass Pollen Extracts are clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing.2, 4, 5, 6 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter."
},
{
"NDCCode": "65044-0825-2",
"PackageDescription": "10 mL in 1 VIAL (65044-0825-2) ",
"NDC11Code": "65044-0825-02",
"ProductNDC": "65044-0825",
"ProductTypeName": "STANDARDIZED ALLERGENIC",
"ProprietaryName": "Standardized Grass Pollen, Sweet Vernal Grass",
"NonProprietaryName": "Standardized Grass Pollen, Sweet Vernal Grass",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19980115",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103878",
"LabelerName": "Jubilant HollisterStier LLC",
"SubstanceName": "ANTHOXANTHUM ODORATUM POLLEN",
"StrengthNumber": "10000",
"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": "2026-03-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19980115",
"SamplePackage": "N",
"IndicationAndUsage": "Standardized Grass Pollen Extracts [see Description (11)] are indicated for: 1 Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10, 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen.",
"Description": "This prescribing information covers eight Standardized Grass Pollen Extracts. The term 'Standardized Grass Pollen Extracts' as used throughout labeling specifically refers to all eight products listed in the Product Title in Highlights of Prescribing Information. Standardized Grass Pollen Extracts include Standardized Bermuda Grass Pollen (Cynodon dactylon) at 10,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate and 50 % glycerin by volume as a preservative and Standardized Kentucky Blue (June) Grass Pollen (Poa pratensis), Standardized Meadow Fescue Grass Pollen (Festuca elatior), Standardized Orchard Grass Pollen (Dactylis glomerata), Standardized Perennial Rye Grass Pollen (Lolium perenne), Standardized Redtop Grass Pollen (Agrostis alba), Standardized Sweet Vernal Grass Pollen (Anthoxanthum odoratum), and Standardized Timothy Grass Pollen (Phleum pratense) at 100,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate, and 50 % glycerin by volume as a preservative. Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Extracts are administered percutaneously, intradermally and subcutaneously. Standardized Grass Pollen Extracts are clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing.2, 4, 5, 6 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter."
},
{
"NDCCode": "65044-0826-2",
"PackageDescription": "10 mL in 1 VIAL (65044-0826-2) ",
"NDC11Code": "65044-0826-02",
"ProductNDC": "65044-0826",
"ProductTypeName": "STANDARDIZED ALLERGENIC",
"ProprietaryName": "Standardized Grass Pollen, Sweet Vernal Grass",
"NonProprietaryName": "Standardized Grass Pollen, Sweet Vernal Grass",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19980115",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103878",
"LabelerName": "Jubilant HollisterStier LLC",
"SubstanceName": "ANTHOXANTHUM ODORATUM 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": "2026-03-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19980115",
"SamplePackage": "N",
"IndicationAndUsage": "Standardized Grass Pollen Extracts [see Description (11)] are indicated for: 1 Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10, 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen.",
"Description": "This prescribing information covers eight Standardized Grass Pollen Extracts. The term 'Standardized Grass Pollen Extracts' as used throughout labeling specifically refers to all eight products listed in the Product Title in Highlights of Prescribing Information. Standardized Grass Pollen Extracts include Standardized Bermuda Grass Pollen (Cynodon dactylon) at 10,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate and 50 % glycerin by volume as a preservative and Standardized Kentucky Blue (June) Grass Pollen (Poa pratensis), Standardized Meadow Fescue Grass Pollen (Festuca elatior), Standardized Orchard Grass Pollen (Dactylis glomerata), Standardized Perennial Rye Grass Pollen (Lolium perenne), Standardized Redtop Grass Pollen (Agrostis alba), Standardized Sweet Vernal Grass Pollen (Anthoxanthum odoratum), and Standardized Timothy Grass Pollen (Phleum pratense) at 100,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate, and 50 % glycerin by volume as a preservative. Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Extracts are administered percutaneously, intradermally and subcutaneously. Standardized Grass Pollen Extracts are clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing.2, 4, 5, 6 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter."
},
{
"NDCCode": "65044-0831-2",
"PackageDescription": "10 mL in 1 VIAL (65044-0831-2) ",
"NDC11Code": "65044-0831-02",
"ProductNDC": "65044-0831",
"ProductTypeName": "STANDARDIZED ALLERGENIC",
"ProprietaryName": "Standardized Grass Pollen, Timothy",
"NonProprietaryName": "Standardized Grass Pollen, Timothy",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19980115",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103879",
"LabelerName": "Jubilant HollisterStier LLC",
"SubstanceName": "PHLEUM PRATENSE POLLEN",
"StrengthNumber": "10000",
"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": "2026-03-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19980115",
"SamplePackage": "N",
"IndicationAndUsage": "Standardized Grass Pollen Extracts [see Description (11)] are indicated for: 1 Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10, 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen.",
"Description": "This prescribing information covers eight Standardized Grass Pollen Extracts. The term 'Standardized Grass Pollen Extracts' as used throughout labeling specifically refers to all eight products listed in the Product Title in Highlights of Prescribing Information. Standardized Grass Pollen Extracts include Standardized Bermuda Grass Pollen (Cynodon dactylon) at 10,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate and 50 % glycerin by volume as a preservative and Standardized Kentucky Blue (June) Grass Pollen (Poa pratensis), Standardized Meadow Fescue Grass Pollen (Festuca elatior), Standardized Orchard Grass Pollen (Dactylis glomerata), Standardized Perennial Rye Grass Pollen (Lolium perenne), Standardized Redtop Grass Pollen (Agrostis alba), Standardized Sweet Vernal Grass Pollen (Anthoxanthum odoratum), and Standardized Timothy Grass Pollen (Phleum pratense) at 100,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate, and 50 % glycerin by volume as a preservative. Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Extracts are administered percutaneously, intradermally and subcutaneously. Standardized Grass Pollen Extracts are clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing.2, 4, 5, 6 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter."
},
{
"NDCCode": "65044-0841-2",
"PackageDescription": "10 mL in 1 VIAL (65044-0841-2) ",
"NDC11Code": "65044-0841-02",
"ProductNDC": "65044-0841",
"ProductTypeName": "STANDARDIZED ALLERGENIC",
"ProprietaryName": "Standardized Grass Pollen, Grass Mix 4",
"NonProprietaryName": "Standardized Grass Pollen, Grass Mix 4",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
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"LabelerName": "Jubilant HollisterStier LLC",
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"SamplePackage": "N"
},
{
"NDCCode": "65044-0842-2",
"PackageDescription": "10 mL in 1 VIAL (65044-0842-2) ",
"NDC11Code": "65044-0842-02",
"ProductNDC": "65044-0842",
"ProductTypeName": "STANDARDIZED ALLERGENIC",
"ProprietaryName": "Standardized Grass Pollen, Grass Mix 4",
"NonProprietaryName": "Standardized Grass Pollen, Grass Mix 4",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19980115",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103873",
"LabelerName": "Jubilant HollisterStier LLC",
"SubstanceName": "POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; AGROSTIS GIGANTEA POLLEN; PHLEUM PRATENSE POLLEN",
"StrengthNumber": "25000; 25000; 25000; 25000",
"StrengthUnit": "[BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19980115",
"SamplePackage": "N",
"IndicationAndUsage": "Standardized Grass Pollen Extracts [see Description (11)] are indicated for: 1 Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10, 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen.",
"Description": "This prescribing information covers eight Standardized Grass Pollen Extracts. The term 'Standardized Grass Pollen Extracts' as used throughout labeling specifically refers to all eight products listed in the Product Title in Highlights of Prescribing Information. Standardized Grass Pollen Extracts include Standardized Bermuda Grass Pollen (Cynodon dactylon) at 10,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate and 50 % glycerin by volume as a preservative and Standardized Kentucky Blue (June) Grass Pollen (Poa pratensis), Standardized Meadow Fescue Grass Pollen (Festuca elatior), Standardized Orchard Grass Pollen (Dactylis glomerata), Standardized Perennial Rye Grass Pollen (Lolium perenne), Standardized Redtop Grass Pollen (Agrostis alba), Standardized Sweet Vernal Grass Pollen (Anthoxanthum odoratum), and Standardized Timothy Grass Pollen (Phleum pratense) at 100,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate, and 50 % glycerin by volume as a preservative. Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Extracts are administered percutaneously, intradermally and subcutaneously. Standardized Grass Pollen Extracts are clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing.2, 4, 5, 6 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter."
}
]
}
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<NDCList>
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<NDCCode>65044-0832-2</NDCCode>
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<NDC11Code>65044-0832-02</NDC11Code>
<ProductNDC>65044-0832</ProductNDC>
<ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Standardized Grass Pollen, Timothy</ProprietaryName>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<IndicationAndUsage>Standardized Grass Pollen Extracts [see Description (11)] are indicated for: 1 Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10, 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen.</IndicationAndUsage>
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<NDC>
<NDCCode>65044-0832-1</NDCCode>
<PackageDescription>5 mL in 1 VIAL (65044-0832-1) </PackageDescription>
<NDC11Code>65044-0832-01</NDC11Code>
<ProductNDC>65044-0832</ProductNDC>
<ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
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<StrengthUnit>[BAU]/mL</StrengthUnit>
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<Status>Active</Status>
<LastUpdate>2026-03-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Standardized Grass Pollen Extracts [see Description (11)] are indicated for: 1 Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10, 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen.</IndicationAndUsage>
<Description>This prescribing information covers eight Standardized Grass Pollen Extracts. The term 'Standardized Grass Pollen Extracts' as used throughout labeling specifically refers to all eight products listed in the Product Title in Highlights of Prescribing Information. Standardized Grass Pollen Extracts include Standardized Bermuda Grass Pollen (Cynodon dactylon) at 10,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate and 50 % glycerin by volume as a preservative and Standardized Kentucky Blue (June) Grass Pollen (Poa pratensis), Standardized Meadow Fescue Grass Pollen (Festuca elatior), Standardized Orchard Grass Pollen (Dactylis glomerata), Standardized Perennial Rye Grass Pollen (Lolium perenne), Standardized Redtop Grass Pollen (Agrostis alba), Standardized Sweet Vernal Grass Pollen (Anthoxanthum odoratum), and Standardized Timothy Grass Pollen (Phleum pratense) at 100,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate, and 50 % glycerin by volume as a preservative. Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Extracts are administered percutaneously, intradermally and subcutaneously. Standardized Grass Pollen Extracts are clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing.2, 4, 5, 6 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter.</Description>
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<NDC>
<NDCCode>65044-0832-3</NDCCode>
<PackageDescription>30 mL in 1 VIAL (65044-0832-3) </PackageDescription>
<NDC11Code>65044-0832-03</NDC11Code>
<ProductNDC>65044-0832</ProductNDC>
<ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Standardized Grass Pollen, Timothy</ProprietaryName>
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<SubstanceName>PHLEUM PRATENSE POLLEN</SubstanceName>
<StrengthNumber>100000</StrengthNumber>
<StrengthUnit>[BAU]/mL</StrengthUnit>
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<LastUpdate>2026-03-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Standardized Grass Pollen Extracts [see Description (11)] are indicated for: 1 Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10, 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen.</IndicationAndUsage>
<Description>This prescribing information covers eight Standardized Grass Pollen Extracts. The term 'Standardized Grass Pollen Extracts' as used throughout labeling specifically refers to all eight products listed in the Product Title in Highlights of Prescribing Information. Standardized Grass Pollen Extracts include Standardized Bermuda Grass Pollen (Cynodon dactylon) at 10,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate and 50 % glycerin by volume as a preservative and Standardized Kentucky Blue (June) Grass Pollen (Poa pratensis), Standardized Meadow Fescue Grass Pollen (Festuca elatior), Standardized Orchard Grass Pollen (Dactylis glomerata), Standardized Perennial Rye Grass Pollen (Lolium perenne), Standardized Redtop Grass Pollen (Agrostis alba), Standardized Sweet Vernal Grass Pollen (Anthoxanthum odoratum), and Standardized Timothy Grass Pollen (Phleum pratense) at 100,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate, and 50 % glycerin by volume as a preservative. Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Extracts are administered percutaneously, intradermally and subcutaneously. Standardized Grass Pollen Extracts are clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing.2, 4, 5, 6 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter.</Description>
</NDC>
<NDC>
<NDCCode>65044-0832-4</NDCCode>
<PackageDescription>50 mL in 1 VIAL (65044-0832-4) </PackageDescription>
<NDC11Code>65044-0832-04</NDC11Code>
<ProductNDC>65044-0832</ProductNDC>
<ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Standardized Grass Pollen, Timothy</ProprietaryName>
<NonProprietaryName>Standardized Grass Pollen, Timothy</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19980115</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103879</ApplicationNumber>
<LabelerName>Jubilant HollisterStier LLC</LabelerName>
<SubstanceName>PHLEUM PRATENSE 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>2026-03-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Standardized Grass Pollen Extracts [see Description (11)] are indicated for: 1 Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10, 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen.</IndicationAndUsage>
<Description>This prescribing information covers eight Standardized Grass Pollen Extracts. The term 'Standardized Grass Pollen Extracts' as used throughout labeling specifically refers to all eight products listed in the Product Title in Highlights of Prescribing Information. Standardized Grass Pollen Extracts include Standardized Bermuda Grass Pollen (Cynodon dactylon) at 10,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate and 50 % glycerin by volume as a preservative and Standardized Kentucky Blue (June) Grass Pollen (Poa pratensis), Standardized Meadow Fescue Grass Pollen (Festuca elatior), Standardized Orchard Grass Pollen (Dactylis glomerata), Standardized Perennial Rye Grass Pollen (Lolium perenne), Standardized Redtop Grass Pollen (Agrostis alba), Standardized Sweet Vernal Grass Pollen (Anthoxanthum odoratum), and Standardized Timothy Grass Pollen (Phleum pratense) at 100,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate, and 50 % glycerin by volume as a preservative. Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Extracts are administered percutaneously, intradermally and subcutaneously. Standardized Grass Pollen Extracts are clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing.2, 4, 5, 6 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter.</Description>
</NDC>
<NDC>
<NDCCode>0832-1121-42</NDCCode>
<PackageDescription>2 BOTTLE, PUMP in 1 CARTON (0832-1121-42) / 60 GEL, METERED in 1 BOTTLE, PUMP (0832-1121-40) </PackageDescription>
<NDC11Code>00832-1121-42</NDC11Code>
<ProductNDC>0832-1121</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Testosterone</ProprietaryName>
<NonProprietaryName>Testosterone</NonProprietaryName>
<DosageFormName>GEL, METERED</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140616</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA204399</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
<SubstanceName>TESTOSTERONE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-07-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140616</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Testosterone gel is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: 1 Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone levels and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range., 2 Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum levels but have gonadotropins in the normal or low range.</IndicationAndUsage>
<Description>Testosterone gel, for topical use is a clear to translucent hydroalcoholic topical gel containing testosterone, an androgen. Testosterone gel provides continuous transdermal delivery of testosterone for 24 hours, following a single application to intact, clean, dry skin of the shoulders and/or upper arms. Testosterone gel is available in unit-dose tubes, unit-dose packets, and a metered-dose pump. One 5-g or two 5-g tubes/packets of testosterone gel contains 50 mg or 100 mg of testosterone, respectively. One pump actuation dispenses 1.25 g of gel, which contains 12.5 mg of testosterone. Four pump actuations or eight pump actuations contain 50 mg or 100 mg of testosterone, respectively. Each metered-dose pump container is capable of dispensing 60 pump actuations. The active pharmacological ingredient in testosterone gel is testosterone. Testosterone USP is a white to practically white crystalline powder chemically described as 17-β hydroxyandrost-4-en-3-one. The structural formula is shown in the following figure. Inactive ingredients in testosterone gel are carbomer copolymer Type B, carbomer homopolymer Type C, diisopropyl adipate, ethyl alcohol, glycerin, methyl laurate, oleyl alcohol, polyethylene glycol, propylene glycol, purified water, and tromethamine.</Description>
</NDC>
<NDC>
<NDCCode>17856-0832-1</NDCCode>
<PackageDescription>50 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0832-1) / 30 mL in 1 CUP, UNIT-DOSE (17856-0832-2) </PackageDescription>
<NDC11Code>17856-0832-01</NDC11Code>
<ProductNDC>17856-0832</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sunmark</ProprietaryName>
<NonProprietaryName>Mineral</NonProprietaryName>
<DosageFormName>OIL</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190410</StartMarketingDate>
<EndMarketingDate>20250718</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M</ApplicationNumber>
<LabelerName>ATLANTIC BIOLOGICALS CORP.</LabelerName>
<SubstanceName>MINERAL OIL</SubstanceName>
<StrengthNumber>999</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-07-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20240520</StartMarketingDatePackage>
<EndMarketingDatePackage>20250718</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for relief of occasional constipation (irregularity). Generally produces bowel movement in 6 to 8 hours.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>37662-0832-2</NDCCode>
<PackageDescription>500 PELLET in 1 VIAL, GLASS (37662-0832-2) </PackageDescription>
<NDC11Code>37662-0832-02</NDC11Code>
<ProductNDC>37662-0832</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Euphrasia Officinalis</ProprietaryName>
<NonProprietaryName>Euphrasia Officinalis</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220712</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>EUPHRASIA STRICTA</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>[hp_M]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-07-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220712</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49187-0832-2</NDCCode>
<PackageDescription>35 kg in 1 BAG (49187-0832-2) </PackageDescription>
<NDC11Code>49187-0832-02</NDC11Code>
<ProductNDC>49187-0832</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Eslicarbazepin Acetate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20111230</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Lonza AG</LabelerName>
<SubstanceName>ESLICARBAZEPINE ACETATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-12-18</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>30-DEC-11</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>52372-0832-2</NDCCode>
<PackageDescription>1 g in 1 CONTAINER (52372-0832-2)</PackageDescription>
<NDC11Code>52372-0832-02</NDC11Code>
<ProductNDC>52372-0832</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Budesonide Micronized</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20120101</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Freedom Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>BUDESONIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>60905-0832-2</NDCCode>
<PackageDescription>10 mL in 1 BOTTLE, PLASTIC (60905-0832-2) </PackageDescription>
<NDC11Code>60905-0832-02</NDC11Code>
<ProductNDC>60905-0832</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Teint Couture Everwear 24h Wear Satin Finish Full Coverage And Comfort Broad Spectrum Spf 20 Y207</ProprietaryName>
<NonProprietaryName>Octinoxate, Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20191001</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>LVMH FRAGRANCE BRANDS</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>30; 17.5</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191001</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>helps prevent sunburn if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun Directions.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>64942-0832-2</NDCCode>
<PackageDescription>45 g in 1 CONTAINER (64942-0832-2)</PackageDescription>
<NDC11Code>64942-0832-02</NDC11Code>
<ProductNDC>64942-0832</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Degree Women Sheer Powder</ProprietaryName>
<ProprietaryNameSuffix>Antiperspirant And Deodorant</ProprietaryNameSuffix>
<NonProprietaryName>Aluminum Zirconium Tetrachlorohydrex Gly</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part350</ApplicationNumber>
<LabelerName>Conopco Inc. d/b/a Unilever</LabelerName>
<SubstanceName>ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY</SubstanceName>
<StrengthNumber>17.8</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>67296-0832-2</NDCCode>
<PackageDescription>10 TABLET in 1 BOTTLE (67296-0832-2) </PackageDescription>
<NDC11Code>67296-0832-02</NDC11Code>
<ProductNDC>67296-0832</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131018</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091393</ApplicationNumber>
<LabelerName>RedPharm Drug, Inc.</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131018</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone hydrochloride tablets are an immediate-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain where the use of an opioid analgesic is appropriate.</IndicationAndUsage>
<Description>Oxycodone hydrochloride tablets USP is an opioid analgesic. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. [2df71fa4-figure-01]. The tablets contain the following inactive ingredients: corn starch; lactose monohydrate; microcrystalline cellulose; silicon dioxide; sodium starch glycolate; and stearic acid. The 10 mg tablet also contains D&C Red No. 27 aluminum lake. The 15 mg tablet also contains D&C Yellow No. 10 aluminum lake and FD&C Blue No. 2 aluminum lake. The 20 mg tablet also contains FD&C Blue No. 2 aluminum lake; FD&C Red No. 40 aluminum lake; and FD&C Yellow No. 6 aluminum lake. The 30 mg tablet also contains FD&C Blue No. 2 aluminum lake. The 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg tablets contain the equivalent of 4.5 mg, 9 mg, 13.5 mg, 18 mg, and 27 mg, respectively, of oxycodone free base.</Description>
</NDC>
<NDC>
<NDCCode>71335-0832-2</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (71335-0832-2) </PackageDescription>
<NDC11Code>71335-0832-02</NDC11Code>
<ProductNDC>71335-0832</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160919</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070178</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180521</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>72303-0832-2</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (72303-0832-2) </PackageDescription>
<NDC11Code>72303-0832-02</NDC11Code>
<ProductNDC>72303-0832</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Solifenacin Succinate</ProprietaryName>
<NonProprietaryName>Solifenacin Succinate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213346</ApplicationNumber>
<LabelerName>HEC Pharm USA Inc.</LabelerName>
<SubstanceName>SOLIFENACIN SUCCINATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Solifenacin succinate is indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.</IndicationAndUsage>
<Description>Solifenacin succinate is a muscarinic receptor antagonist. Chemically, solifenacin succinate is a butanedioic acid compound with (1 S)-(3 R)-1-azabicyclo[2.2.2]oct-3-yl 3,4-dihydro-1-phenyl-2(1 H)-iso-quinolinecarboxylate (1:1) having an empirical formula of C 23H 26N 2O 2C 4H 6O 4, and a molecular weight of 480.55. The structural formula of solifenacin succinate is:. Solifenacin succinate is a white to pale-yellowish-white crystal or crystalline powder. It is freely soluble at room temperature in water, glacial acetic acid, dimethyl sulfoxide, and methanol. Each solifenacin succinate tablet contains 5 or 10 mg of solifenacin succinate and is for oral administration. In addition to the active ingredient solifenacin succinate, each solifenacin succinate tablet also contains the following inactive ingredients: hypromellose, lactose anhydrous, magnesium stearate, silicified microcrystalline cellulose, lactose monohydrate, titanium dioxide and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>65044-0537-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL (65044-0537-2) </PackageDescription>
<NDC11Code>65044-0537-02</NDC11Code>
<ProductNDC>65044-0537</ProductNDC>
<ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Standardized Grass Pollen, Bermuda Grass</ProprietaryName>
<NonProprietaryName>Standardized Grass Pollen, Bermuda Grass</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19980115</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103872</ApplicationNumber>
<LabelerName>Jubilant HollisterStier LLC</LabelerName>
<SubstanceName>CYNODON DACTYLON POLLEN</SubstanceName>
<StrengthNumber>10000</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>2026-03-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Standardized Grass Pollen Extracts [see Description (11)] are indicated for: 1 Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10, 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen.</IndicationAndUsage>
<Description>This prescribing information covers eight Standardized Grass Pollen Extracts. The term 'Standardized Grass Pollen Extracts' as used throughout labeling specifically refers to all eight products listed in the Product Title in Highlights of Prescribing Information. Standardized Grass Pollen Extracts include Standardized Bermuda Grass Pollen (Cynodon dactylon) at 10,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate and 50 % glycerin by volume as a preservative and Standardized Kentucky Blue (June) Grass Pollen (Poa pratensis), Standardized Meadow Fescue Grass Pollen (Festuca elatior), Standardized Orchard Grass Pollen (Dactylis glomerata), Standardized Perennial Rye Grass Pollen (Lolium perenne), Standardized Redtop Grass Pollen (Agrostis alba), Standardized Sweet Vernal Grass Pollen (Anthoxanthum odoratum), and Standardized Timothy Grass Pollen (Phleum pratense) at 100,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate, and 50 % glycerin by volume as a preservative. Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Extracts are administered percutaneously, intradermally and subcutaneously. Standardized Grass Pollen Extracts are clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing.2, 4, 5, 6 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter.</Description>
</NDC>
<NDC>
<NDCCode>65044-0545-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL (65044-0545-2) </PackageDescription>
<NDC11Code>65044-0545-02</NDC11Code>
<ProductNDC>65044-0545</ProductNDC>
<ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Standardized Grass Pollen, Bluegrass, Kentucky June</ProprietaryName>
<NonProprietaryName>Standardized Grass Pollen, Bluegrass, Kentucky June</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19980115</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103873</ApplicationNumber>
<LabelerName>Jubilant HollisterStier LLC</LabelerName>
<SubstanceName>POA PRATENSIS POLLEN</SubstanceName>
<StrengthNumber>10000</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>2026-03-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Standardized Grass Pollen Extracts [see Description (11)] are indicated for: 1 Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10, 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen.</IndicationAndUsage>
<Description>This prescribing information covers eight Standardized Grass Pollen Extracts. The term 'Standardized Grass Pollen Extracts' as used throughout labeling specifically refers to all eight products listed in the Product Title in Highlights of Prescribing Information. Standardized Grass Pollen Extracts include Standardized Bermuda Grass Pollen (Cynodon dactylon) at 10,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate and 50 % glycerin by volume as a preservative and Standardized Kentucky Blue (June) Grass Pollen (Poa pratensis), Standardized Meadow Fescue Grass Pollen (Festuca elatior), Standardized Orchard Grass Pollen (Dactylis glomerata), Standardized Perennial Rye Grass Pollen (Lolium perenne), Standardized Redtop Grass Pollen (Agrostis alba), Standardized Sweet Vernal Grass Pollen (Anthoxanthum odoratum), and Standardized Timothy Grass Pollen (Phleum pratense) at 100,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate, and 50 % glycerin by volume as a preservative. Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Extracts are administered percutaneously, intradermally and subcutaneously. Standardized Grass Pollen Extracts are clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing.2, 4, 5, 6 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter.</Description>
</NDC>
<NDC>
<NDCCode>65044-0546-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL (65044-0546-2) </PackageDescription>
<NDC11Code>65044-0546-02</NDC11Code>
<ProductNDC>65044-0546</ProductNDC>
<ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Standardized Grass Pollen, Bluegrass, Kentucky June</ProprietaryName>
<NonProprietaryName>Standardized Grass Pollen, Bluegrass, Kentucky June</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19980115</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103873</ApplicationNumber>
<LabelerName>Jubilant HollisterStier LLC</LabelerName>
<SubstanceName>POA 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>2026-03-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Standardized Grass Pollen Extracts [see Description (11)] are indicated for: 1 Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10, 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen.</IndicationAndUsage>
<Description>This prescribing information covers eight Standardized Grass Pollen Extracts. The term 'Standardized Grass Pollen Extracts' as used throughout labeling specifically refers to all eight products listed in the Product Title in Highlights of Prescribing Information. Standardized Grass Pollen Extracts include Standardized Bermuda Grass Pollen (Cynodon dactylon) at 10,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate and 50 % glycerin by volume as a preservative and Standardized Kentucky Blue (June) Grass Pollen (Poa pratensis), Standardized Meadow Fescue Grass Pollen (Festuca elatior), Standardized Orchard Grass Pollen (Dactylis glomerata), Standardized Perennial Rye Grass Pollen (Lolium perenne), Standardized Redtop Grass Pollen (Agrostis alba), Standardized Sweet Vernal Grass Pollen (Anthoxanthum odoratum), and Standardized Timothy Grass Pollen (Phleum pratense) at 100,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate, and 50 % glycerin by volume as a preservative. Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Extracts are administered percutaneously, intradermally and subcutaneously. Standardized Grass Pollen Extracts are clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing.2, 4, 5, 6 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter.</Description>
</NDC>
<NDC>
<NDCCode>65044-0611-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL (65044-0611-2) </PackageDescription>
<NDC11Code>65044-0611-02</NDC11Code>
<ProductNDC>65044-0611</ProductNDC>
<ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Standardized Grass Pollen, Fescue, Meadow</ProprietaryName>
<NonProprietaryName>Standardized Grass Pollen, Fescue, Meadow</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19980115</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103874</ApplicationNumber>
<LabelerName>Jubilant HollisterStier LLC</LabelerName>
<SubstanceName>LOLIUM PRATENSE POLLEN</SubstanceName>
<StrengthNumber>10000</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>2026-03-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Standardized Grass Pollen Extracts [see Description (11)] are indicated for: 1 Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10, 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen.</IndicationAndUsage>
<Description>This prescribing information covers eight Standardized Grass Pollen Extracts. The term 'Standardized Grass Pollen Extracts' as used throughout labeling specifically refers to all eight products listed in the Product Title in Highlights of Prescribing Information. Standardized Grass Pollen Extracts include Standardized Bermuda Grass Pollen (Cynodon dactylon) at 10,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate and 50 % glycerin by volume as a preservative and Standardized Kentucky Blue (June) Grass Pollen (Poa pratensis), Standardized Meadow Fescue Grass Pollen (Festuca elatior), Standardized Orchard Grass Pollen (Dactylis glomerata), Standardized Perennial Rye Grass Pollen (Lolium perenne), Standardized Redtop Grass Pollen (Agrostis alba), Standardized Sweet Vernal Grass Pollen (Anthoxanthum odoratum), and Standardized Timothy Grass Pollen (Phleum pratense) at 100,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate, and 50 % glycerin by volume as a preservative. Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Extracts are administered percutaneously, intradermally and subcutaneously. Standardized Grass Pollen Extracts are clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing.2, 4, 5, 6 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter.</Description>
</NDC>
<NDC>
<NDCCode>65044-0612-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL (65044-0612-2) </PackageDescription>
<NDC11Code>65044-0612-02</NDC11Code>
<ProductNDC>65044-0612</ProductNDC>
<ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Standardized Grass Pollen, Fescue, Meadow</ProprietaryName>
<NonProprietaryName>Standardized Grass Pollen, Fescue, Meadow</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19980115</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103874</ApplicationNumber>
<LabelerName>Jubilant HollisterStier LLC</LabelerName>
<SubstanceName>LOLIUM PRATENSE 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>2026-03-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Standardized Grass Pollen Extracts [see Description (11)] are indicated for: 1 Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10, 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen.</IndicationAndUsage>
<Description>This prescribing information covers eight Standardized Grass Pollen Extracts. The term 'Standardized Grass Pollen Extracts' as used throughout labeling specifically refers to all eight products listed in the Product Title in Highlights of Prescribing Information. Standardized Grass Pollen Extracts include Standardized Bermuda Grass Pollen (Cynodon dactylon) at 10,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate and 50 % glycerin by volume as a preservative and Standardized Kentucky Blue (June) Grass Pollen (Poa pratensis), Standardized Meadow Fescue Grass Pollen (Festuca elatior), Standardized Orchard Grass Pollen (Dactylis glomerata), Standardized Perennial Rye Grass Pollen (Lolium perenne), Standardized Redtop Grass Pollen (Agrostis alba), Standardized Sweet Vernal Grass Pollen (Anthoxanthum odoratum), and Standardized Timothy Grass Pollen (Phleum pratense) at 100,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate, and 50 % glycerin by volume as a preservative. Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Extracts are administered percutaneously, intradermally and subcutaneously. Standardized Grass Pollen Extracts are clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing.2, 4, 5, 6 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter.</Description>
</NDC>
<NDC>
<NDCCode>65044-0718-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL (65044-0718-2) </PackageDescription>
<NDC11Code>65044-0718-02</NDC11Code>
<ProductNDC>65044-0718</ProductNDC>
<ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Standardized Grass Pollen, Orchard Grass</ProprietaryName>
<NonProprietaryName>Standardized Grass Pollen, Orchard Grass</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19980115</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103875</ApplicationNumber>
<LabelerName>Jubilant HollisterStier LLC</LabelerName>
<SubstanceName>DACTYLIS GLOMERATA POLLEN</SubstanceName>
<StrengthNumber>10000</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>2026-03-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Standardized Grass Pollen Extracts [see Description (11)] are indicated for: 1 Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10, 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen.</IndicationAndUsage>
<Description>This prescribing information covers eight Standardized Grass Pollen Extracts. The term 'Standardized Grass Pollen Extracts' as used throughout labeling specifically refers to all eight products listed in the Product Title in Highlights of Prescribing Information. Standardized Grass Pollen Extracts include Standardized Bermuda Grass Pollen (Cynodon dactylon) at 10,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate and 50 % glycerin by volume as a preservative and Standardized Kentucky Blue (June) Grass Pollen (Poa pratensis), Standardized Meadow Fescue Grass Pollen (Festuca elatior), Standardized Orchard Grass Pollen (Dactylis glomerata), Standardized Perennial Rye Grass Pollen (Lolium perenne), Standardized Redtop Grass Pollen (Agrostis alba), Standardized Sweet Vernal Grass Pollen (Anthoxanthum odoratum), and Standardized Timothy Grass Pollen (Phleum pratense) at 100,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate, and 50 % glycerin by volume as a preservative. Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Extracts are administered percutaneously, intradermally and subcutaneously. Standardized Grass Pollen Extracts are clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing.2, 4, 5, 6 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter.</Description>
</NDC>
<NDC>
<NDCCode>65044-0719-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL (65044-0719-2) </PackageDescription>
<NDC11Code>65044-0719-02</NDC11Code>
<ProductNDC>65044-0719</ProductNDC>
<ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Standardized Grass Pollen, Orchard Grass</ProprietaryName>
<NonProprietaryName>Standardized Grass Pollen, Orchard Grass</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19980115</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103875</ApplicationNumber>
<LabelerName>Jubilant HollisterStier LLC</LabelerName>
<SubstanceName>DACTYLIS GLOMERATA 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>2026-03-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Standardized Grass Pollen Extracts [see Description (11)] are indicated for: 1 Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10, 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen.</IndicationAndUsage>
<Description>This prescribing information covers eight Standardized Grass Pollen Extracts. The term 'Standardized Grass Pollen Extracts' as used throughout labeling specifically refers to all eight products listed in the Product Title in Highlights of Prescribing Information. Standardized Grass Pollen Extracts include Standardized Bermuda Grass Pollen (Cynodon dactylon) at 10,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate and 50 % glycerin by volume as a preservative and Standardized Kentucky Blue (June) Grass Pollen (Poa pratensis), Standardized Meadow Fescue Grass Pollen (Festuca elatior), Standardized Orchard Grass Pollen (Dactylis glomerata), Standardized Perennial Rye Grass Pollen (Lolium perenne), Standardized Redtop Grass Pollen (Agrostis alba), Standardized Sweet Vernal Grass Pollen (Anthoxanthum odoratum), and Standardized Timothy Grass Pollen (Phleum pratense) at 100,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate, and 50 % glycerin by volume as a preservative. Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Extracts are administered percutaneously, intradermally and subcutaneously. Standardized Grass Pollen Extracts are clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing.2, 4, 5, 6 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter.</Description>
</NDC>
<NDC>
<NDCCode>65044-0777-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL (65044-0777-2) </PackageDescription>
<NDC11Code>65044-0777-02</NDC11Code>
<ProductNDC>65044-0777</ProductNDC>
<ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Standardized Grass Pollen, Redtop</ProprietaryName>
<NonProprietaryName>Standardized Grass Pollen, Redtop</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19980115</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103876</ApplicationNumber>
<LabelerName>Jubilant HollisterStier LLC</LabelerName>
<SubstanceName>AGROSTIS GIGANTEA POLLEN</SubstanceName>
<StrengthNumber>10000</StrengthNumber>
<StrengthUnit>[BAU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Standardized Grass Pollen Extracts [see Description (11)] are indicated for: 1 Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10, 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen.</IndicationAndUsage>
<Description>This prescribing information covers eight Standardized Grass Pollen Extracts. The term 'Standardized Grass Pollen Extracts' as used throughout labeling specifically refers to all eight products listed in the Product Title in Highlights of Prescribing Information. Standardized Grass Pollen Extracts include Standardized Bermuda Grass Pollen (Cynodon dactylon) at 10,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate and 50 % glycerin by volume as a preservative and Standardized Kentucky Blue (June) Grass Pollen (Poa pratensis), Standardized Meadow Fescue Grass Pollen (Festuca elatior), Standardized Orchard Grass Pollen (Dactylis glomerata), Standardized Perennial Rye Grass Pollen (Lolium perenne), Standardized Redtop Grass Pollen (Agrostis alba), Standardized Sweet Vernal Grass Pollen (Anthoxanthum odoratum), and Standardized Timothy Grass Pollen (Phleum pratense) at 100,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate, and 50 % glycerin by volume as a preservative. Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Extracts are administered percutaneously, intradermally and subcutaneously. Standardized Grass Pollen Extracts are clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing.2, 4, 5, 6 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter.</Description>
</NDC>
<NDC>
<NDCCode>65044-0778-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL (65044-0778-2) </PackageDescription>
<NDC11Code>65044-0778-02</NDC11Code>
<ProductNDC>65044-0778</ProductNDC>
<ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Standardized Grass Pollen, Redtop</ProprietaryName>
<NonProprietaryName>Standardized Grass Pollen, Redtop</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19980115</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103876</ApplicationNumber>
<LabelerName>Jubilant HollisterStier LLC</LabelerName>
<SubstanceName>AGROSTIS GIGANTEA 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], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Standardized Grass Pollen Extracts [see Description (11)] are indicated for: 1 Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10, 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen.</IndicationAndUsage>
<Description>This prescribing information covers eight Standardized Grass Pollen Extracts. The term 'Standardized Grass Pollen Extracts' as used throughout labeling specifically refers to all eight products listed in the Product Title in Highlights of Prescribing Information. Standardized Grass Pollen Extracts include Standardized Bermuda Grass Pollen (Cynodon dactylon) at 10,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate and 50 % glycerin by volume as a preservative and Standardized Kentucky Blue (June) Grass Pollen (Poa pratensis), Standardized Meadow Fescue Grass Pollen (Festuca elatior), Standardized Orchard Grass Pollen (Dactylis glomerata), Standardized Perennial Rye Grass Pollen (Lolium perenne), Standardized Redtop Grass Pollen (Agrostis alba), Standardized Sweet Vernal Grass Pollen (Anthoxanthum odoratum), and Standardized Timothy Grass Pollen (Phleum pratense) at 100,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate, and 50 % glycerin by volume as a preservative. Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Extracts are administered percutaneously, intradermally and subcutaneously. Standardized Grass Pollen Extracts are clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing.2, 4, 5, 6 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter.</Description>
</NDC>
<NDC>
<NDCCode>65044-0787-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL (65044-0787-2) </PackageDescription>
<NDC11Code>65044-0787-02</NDC11Code>
<ProductNDC>65044-0787</ProductNDC>
<ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Standardized Grass Pollen, Ryegrass</ProprietaryName>
<NonProprietaryName>Standardized Grass Pollen, Ryegrass</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19980115</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103877</ApplicationNumber>
<LabelerName>Jubilant HollisterStier LLC</LabelerName>
<SubstanceName>LOLIUM PERENNE POLLEN</SubstanceName>
<StrengthNumber>10000</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>2026-03-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Standardized Grass Pollen Extracts [see Description (11)] are indicated for: 1 Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10, 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen.</IndicationAndUsage>
<Description>This prescribing information covers eight Standardized Grass Pollen Extracts. The term 'Standardized Grass Pollen Extracts' as used throughout labeling specifically refers to all eight products listed in the Product Title in Highlights of Prescribing Information. Standardized Grass Pollen Extracts include Standardized Bermuda Grass Pollen (Cynodon dactylon) at 10,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate and 50 % glycerin by volume as a preservative and Standardized Kentucky Blue (June) Grass Pollen (Poa pratensis), Standardized Meadow Fescue Grass Pollen (Festuca elatior), Standardized Orchard Grass Pollen (Dactylis glomerata), Standardized Perennial Rye Grass Pollen (Lolium perenne), Standardized Redtop Grass Pollen (Agrostis alba), Standardized Sweet Vernal Grass Pollen (Anthoxanthum odoratum), and Standardized Timothy Grass Pollen (Phleum pratense) at 100,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate, and 50 % glycerin by volume as a preservative. Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Extracts are administered percutaneously, intradermally and subcutaneously. Standardized Grass Pollen Extracts are clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing.2, 4, 5, 6 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter.</Description>
</NDC>
<NDC>
<NDCCode>65044-0788-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL (65044-0788-2) </PackageDescription>
<NDC11Code>65044-0788-02</NDC11Code>
<ProductNDC>65044-0788</ProductNDC>
<ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Standardized Grass Pollen, Ryegrass</ProprietaryName>
<NonProprietaryName>Standardized Grass Pollen, Ryegrass</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19980115</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103877</ApplicationNumber>
<LabelerName>Jubilant HollisterStier LLC</LabelerName>
<SubstanceName>LOLIUM PERENNE 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>2026-03-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Standardized Grass Pollen Extracts [see Description (11)] are indicated for: 1 Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10, 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen.</IndicationAndUsage>
<Description>This prescribing information covers eight Standardized Grass Pollen Extracts. The term 'Standardized Grass Pollen Extracts' as used throughout labeling specifically refers to all eight products listed in the Product Title in Highlights of Prescribing Information. Standardized Grass Pollen Extracts include Standardized Bermuda Grass Pollen (Cynodon dactylon) at 10,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate and 50 % glycerin by volume as a preservative and Standardized Kentucky Blue (June) Grass Pollen (Poa pratensis), Standardized Meadow Fescue Grass Pollen (Festuca elatior), Standardized Orchard Grass Pollen (Dactylis glomerata), Standardized Perennial Rye Grass Pollen (Lolium perenne), Standardized Redtop Grass Pollen (Agrostis alba), Standardized Sweet Vernal Grass Pollen (Anthoxanthum odoratum), and Standardized Timothy Grass Pollen (Phleum pratense) at 100,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate, and 50 % glycerin by volume as a preservative. Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Extracts are administered percutaneously, intradermally and subcutaneously. Standardized Grass Pollen Extracts are clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing.2, 4, 5, 6 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter.</Description>
</NDC>
<NDC>
<NDCCode>65044-0825-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL (65044-0825-2) </PackageDescription>
<NDC11Code>65044-0825-02</NDC11Code>
<ProductNDC>65044-0825</ProductNDC>
<ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Standardized Grass Pollen, Sweet Vernal Grass</ProprietaryName>
<NonProprietaryName>Standardized Grass Pollen, Sweet Vernal Grass</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19980115</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103878</ApplicationNumber>
<LabelerName>Jubilant HollisterStier LLC</LabelerName>
<SubstanceName>ANTHOXANTHUM ODORATUM POLLEN</SubstanceName>
<StrengthNumber>10000</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>2026-03-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Standardized Grass Pollen Extracts [see Description (11)] are indicated for: 1 Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10, 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen.</IndicationAndUsage>
<Description>This prescribing information covers eight Standardized Grass Pollen Extracts. The term 'Standardized Grass Pollen Extracts' as used throughout labeling specifically refers to all eight products listed in the Product Title in Highlights of Prescribing Information. Standardized Grass Pollen Extracts include Standardized Bermuda Grass Pollen (Cynodon dactylon) at 10,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate and 50 % glycerin by volume as a preservative and Standardized Kentucky Blue (June) Grass Pollen (Poa pratensis), Standardized Meadow Fescue Grass Pollen (Festuca elatior), Standardized Orchard Grass Pollen (Dactylis glomerata), Standardized Perennial Rye Grass Pollen (Lolium perenne), Standardized Redtop Grass Pollen (Agrostis alba), Standardized Sweet Vernal Grass Pollen (Anthoxanthum odoratum), and Standardized Timothy Grass Pollen (Phleum pratense) at 100,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate, and 50 % glycerin by volume as a preservative. Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Extracts are administered percutaneously, intradermally and subcutaneously. Standardized Grass Pollen Extracts are clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing.2, 4, 5, 6 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter.</Description>
</NDC>
<NDC>
<NDCCode>65044-0826-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL (65044-0826-2) </PackageDescription>
<NDC11Code>65044-0826-02</NDC11Code>
<ProductNDC>65044-0826</ProductNDC>
<ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Standardized Grass Pollen, Sweet Vernal Grass</ProprietaryName>
<NonProprietaryName>Standardized Grass Pollen, Sweet Vernal Grass</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19980115</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103878</ApplicationNumber>
<LabelerName>Jubilant HollisterStier LLC</LabelerName>
<SubstanceName>ANTHOXANTHUM ODORATUM 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>2026-03-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Standardized Grass Pollen Extracts [see Description (11)] are indicated for: 1 Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10, 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen.</IndicationAndUsage>
<Description>This prescribing information covers eight Standardized Grass Pollen Extracts. The term 'Standardized Grass Pollen Extracts' as used throughout labeling specifically refers to all eight products listed in the Product Title in Highlights of Prescribing Information. Standardized Grass Pollen Extracts include Standardized Bermuda Grass Pollen (Cynodon dactylon) at 10,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate and 50 % glycerin by volume as a preservative and Standardized Kentucky Blue (June) Grass Pollen (Poa pratensis), Standardized Meadow Fescue Grass Pollen (Festuca elatior), Standardized Orchard Grass Pollen (Dactylis glomerata), Standardized Perennial Rye Grass Pollen (Lolium perenne), Standardized Redtop Grass Pollen (Agrostis alba), Standardized Sweet Vernal Grass Pollen (Anthoxanthum odoratum), and Standardized Timothy Grass Pollen (Phleum pratense) at 100,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate, and 50 % glycerin by volume as a preservative. Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Extracts are administered percutaneously, intradermally and subcutaneously. Standardized Grass Pollen Extracts are clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing.2, 4, 5, 6 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter.</Description>
</NDC>
<NDC>
<NDCCode>65044-0831-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL (65044-0831-2) </PackageDescription>
<NDC11Code>65044-0831-02</NDC11Code>
<ProductNDC>65044-0831</ProductNDC>
<ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Standardized Grass Pollen, Timothy</ProprietaryName>
<NonProprietaryName>Standardized Grass Pollen, Timothy</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19980115</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103879</ApplicationNumber>
<LabelerName>Jubilant HollisterStier LLC</LabelerName>
<SubstanceName>PHLEUM PRATENSE POLLEN</SubstanceName>
<StrengthNumber>10000</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>2026-03-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Standardized Grass Pollen Extracts [see Description (11)] are indicated for: 1 Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10, 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen.</IndicationAndUsage>
<Description>This prescribing information covers eight Standardized Grass Pollen Extracts. The term 'Standardized Grass Pollen Extracts' as used throughout labeling specifically refers to all eight products listed in the Product Title in Highlights of Prescribing Information. Standardized Grass Pollen Extracts include Standardized Bermuda Grass Pollen (Cynodon dactylon) at 10,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate and 50 % glycerin by volume as a preservative and Standardized Kentucky Blue (June) Grass Pollen (Poa pratensis), Standardized Meadow Fescue Grass Pollen (Festuca elatior), Standardized Orchard Grass Pollen (Dactylis glomerata), Standardized Perennial Rye Grass Pollen (Lolium perenne), Standardized Redtop Grass Pollen (Agrostis alba), Standardized Sweet Vernal Grass Pollen (Anthoxanthum odoratum), and Standardized Timothy Grass Pollen (Phleum pratense) at 100,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate, and 50 % glycerin by volume as a preservative. Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Extracts are administered percutaneously, intradermally and subcutaneously. Standardized Grass Pollen Extracts are clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing.2, 4, 5, 6 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter.</Description>
</NDC>
<NDC>
<NDCCode>65044-0841-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL (65044-0841-2) </PackageDescription>
<NDC11Code>65044-0841-02</NDC11Code>
<ProductNDC>65044-0841</ProductNDC>
<ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Standardized Grass Pollen, Grass Mix 4</ProprietaryName>
<NonProprietaryName>Standardized Grass Pollen, Grass Mix 4</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19980115</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103873</ApplicationNumber>
<LabelerName>Jubilant HollisterStier LLC</LabelerName>
<SubstanceName>POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; AGROSTIS GIGANTEA POLLEN; PHLEUM PRATENSE POLLEN</SubstanceName>
<StrengthNumber>2500; 2500; 2500; 2500</StrengthNumber>
<StrengthUnit>[BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL</StrengthUnit>
<Pharm_Classes>Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-11-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>65044-0842-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL (65044-0842-2) </PackageDescription>
<NDC11Code>65044-0842-02</NDC11Code>
<ProductNDC>65044-0842</ProductNDC>
<ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Standardized Grass Pollen, Grass Mix 4</ProprietaryName>
<NonProprietaryName>Standardized Grass Pollen, Grass Mix 4</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19980115</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103873</ApplicationNumber>
<LabelerName>Jubilant HollisterStier LLC</LabelerName>
<SubstanceName>POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; AGROSTIS GIGANTEA POLLEN; PHLEUM PRATENSE POLLEN</SubstanceName>
<StrengthNumber>25000; 25000; 25000; 25000</StrengthNumber>
<StrengthUnit>[BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Standardized Grass Pollen Extracts [see Description (11)] are indicated for: 1 Skin testing for diagnosis of patients with a clinical history of allergy to one or more of the following grass pollen allergens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy.7, 8, 9, 10, 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen.</IndicationAndUsage>
<Description>This prescribing information covers eight Standardized Grass Pollen Extracts. The term 'Standardized Grass Pollen Extracts' as used throughout labeling specifically refers to all eight products listed in the Product Title in Highlights of Prescribing Information. Standardized Grass Pollen Extracts include Standardized Bermuda Grass Pollen (Cynodon dactylon) at 10,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate and 50 % glycerin by volume as a preservative and Standardized Kentucky Blue (June) Grass Pollen (Poa pratensis), Standardized Meadow Fescue Grass Pollen (Festuca elatior), Standardized Orchard Grass Pollen (Dactylis glomerata), Standardized Perennial Rye Grass Pollen (Lolium perenne), Standardized Redtop Grass Pollen (Agrostis alba), Standardized Sweet Vernal Grass Pollen (Anthoxanthum odoratum), and Standardized Timothy Grass Pollen (Phleum pratense) at 100,000 BAU/mL, 0.5 % sodium chloride, 0.275 % sodium bicarbonate, and 50 % glycerin by volume as a preservative. Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Extracts are administered percutaneously, intradermally and subcutaneously. Standardized Grass Pollen Extracts are clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing.2, 4, 5, 6 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter.</Description>
</NDC>
</NDCList>