{
"NDC": [
{
"NDCCode": "0280-1121-10",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (0280-1121-10) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "00280-1121-10",
"ProductNDC": "0280-1121",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alka-seltzer Plus",
"ProprietaryNameSuffix": "Cold And Cough Formula",
"NonProprietaryName": "Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20131030",
"EndMarketingDate": "20190430",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Bayer HealthCare LLC.",
"SubstanceName": "ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 2; 10; 5",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-05-01",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "0280-1121-20",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (0280-1121-20) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "00280-1121-20",
"ProductNDC": "0280-1121",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alka-seltzer Plus",
"ProprietaryNameSuffix": "Cold And Cough Formula",
"NonProprietaryName": "Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20131030",
"EndMarketingDate": "20190430",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Bayer HealthCare LLC.",
"SubstanceName": "ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 2; 10; 5",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-05-01",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "0280-1121-40",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (0280-1121-40) > 40 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "00280-1121-40",
"ProductNDC": "0280-1121",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alka-seltzer Plus",
"ProprietaryNameSuffix": "Cold And Cough Formula",
"NonProprietaryName": "Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20131030",
"EndMarketingDate": "20190430",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Bayer HealthCare LLC.",
"SubstanceName": "ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 2; 10; 5",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-05-01",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "0115-1121-10",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1121-10)",
"NDC11Code": "00115-1121-10",
"ProductNDC": "0115-1121",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Galantamine Hydrobromide",
"NonProprietaryName": "Galantamine Hydrobromide",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20090527",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078484",
"LabelerName": "Global Pharmaceuticals, Division of Impax Laboratories Inc.",
"SubstanceName": "GALANTAMINE HYDROBROMIDE",
"StrengthNumber": "16",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-04-13"
},
{
"NDCCode": "0268-1121-10",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (0268-1121-10) ",
"NDC11Code": "00268-1121-10",
"ProductNDC": "0268-1121",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Zea Mays Pollen",
"NonProprietaryName": "Corn Pollen",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "19650101",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103753",
"LabelerName": "ALK-Abello, Inc.",
"SubstanceName": "ZEA MAYS POLLEN",
"StrengthNumber": ".05",
"StrengthUnit": "g/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]",
"Status": "Active",
"LastUpdate": "2023-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19650101",
"SamplePackage": "N",
"IndicationAndUsage": "Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust, molds, animal danders, various other inhalants, and in situations where the offending allergen cannot be avoided. Prior to initiation of therapy, the clinical sensitivity should be established by careful evaluation of the patient’s history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can easily be avoided.",
"Description": "Sterile therapeutic extracts are supplied in either Phenol Saline Diluent or in Diluent containing Glycerin 50% (v/v) for subcutaneous injection. Inactive ingredients may include: Sodium Chloride for isotonicity, Glycerin, and Sodium Bicarbonate as buffering agents. These products are compounded and diluted on a w/v or PNU basis. Pollens are individually extracted from pure pollen extracted in a phenol-preserved sodium bicarbonate solution. Short Ragweed and Mixed (Tall and Short) Ragweed extracts are standardized by Antigen E content and so labeled. The Antigen E content of extracts containing Short Ragweed at a concentration more dilute than a weight/volume ratio of 1:10 are obtained by calculating the Antigen E content based on the assay value of more concentrated extract. Pollen extracts are filtered aseptically and, after final packaging, they are tested for sterility and safety. Molds are individually extracted from pure powdered inactivated mold source material extracted in phenol preserved saline. Mold extracts are filtered aseptically and after final packaging are tested for sterility and safety. Molds are present in all inhabited places at all seasons of the year; they are so ubiquitous that they are prevalent at times when common allergic pollens and other inhalants are not. In the home and surroundings, molds are found in upholstered furniture, mattresses, drapes, cellar and storage room dust, woolens, leather goods, fruits, meats, cheeses, garden soil and on plants. Spores, mycelial fragments and mold residues are thus inhaled, contacted and ingested continuously. Miscellaneous inhalants and epidermals are individually extracted in phenol preserved saline, filtered aseptically and after final packaging are tested for sterility and safety."
},
{
"NDCCode": "22840-1121-2",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (22840-1121-2) ",
"NDC11Code": "22840-1121-02",
"ProductNDC": "22840-1121",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Hog Epithelia",
"NonProprietaryName": "Sus Scrofa",
"DosageFormName": "SOLUTION",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19810915",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101833",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "SUS SCROFA SKIN",
"StrengthNumber": ".1",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Cells, Epidermal [EXT], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Animal Skin Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19810915",
"SamplePackage": "N",
"IndicationAndUsage": "Non-Standardized Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens., 2 Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies. .",
"Description": "Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter."
},
{
"NDCCode": "36987-1121-2",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (36987-1121-2)",
"NDC11Code": "36987-1121-02",
"ProductNDC": "36987-1121",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Standardized Cat Hair",
"NonProprietaryName": "Standardized Cat Hair",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19920929",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103384",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "FELIS CATUS HAIR",
"StrengthNumber": "10000",
"StrengthUnit": "[BAU]/mL",
"Pharm_Classes": "Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [CS],Allergens [CS],Salivary Proteins and Peptides [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Standardized Cat Hair is intended for use in the diagnosis and therapy of cat allergy patients as established by allergy history and skin test reactivity.",
"Description": "Standardized cat hair extract is a sterile glycerinated injectable solution containing the extractables of dried, powdered cat hair, wash and dander and 0.5% NaCl, 0.08% Na2HPO4, 0.036% KH2PO4, water for injection and 0.4%, phenol as preservative in sterile containers. All extracts are aseptically filled. Standardized cat hair extract is to be administered by prick-puncture or intradermal routes when used for diagnostic purposes and administered subcutaneously when used for immunotherapy injections. The Bioequivalent Allergy Unit (BAU) nomenclature, now used for all Standardized Cat Extracts, replaces the previous Allergy Unit (AU) nomenclature for these products. Bioequivalent Allergy Units are based on quantitative intradermal skin test results and are intended to assure that the labeled unit of different allergenic extracts will correspond to the expected clinical response in sensitive patients. References labeled 10,000 BAU/mL can be diluted to one half million fold to produce an intradermal sum of erythema diameter response of 50 mm in highly puncture reactive subjects. In vitro assignment of BAU/mL to this product is based on radial immunodiffusion (RID) assay results according to guidelines established by the Center for Biologics Evaluation and Research (CBER) as indicated below.(5, 6). Bioequivalent Allergy Units (BAU) are NOT interchangeable with Allergy Units (AU). Standardized Cat Hair extract labeled in BAU/mL are not interchangeable with standardized cat pelt extracts or with cat hair extracts labeled in AU/mL or with non-standardized cat hair extracts. It has been recognized through investigation that the allergens responsible for Cat allergy are found in the pelt, hair, dander, saliva, serum and urine.(1) Saliva especially when deposited on and in combination with the hair, root hairs and skin can produce a significant allergic reaction. Repeated surface washing of the animal proved significant enough so that the wash was added to the whole of the raw material producing the cat allergenic extract.(2,3,4) However the amount of Fel d 1 varies widely from animal to animal so it is an advantage to use raw material with a known amount of the antigen. Nelco's raw material, supplied by Biopol Laboratory, is dried, powdered cat hair, wash and dander, labeled with the number of Fel d 1 units in each gram of dried material per container. The raw material is extracted with a 50%(v/v) glycerinated diluent containing glycerin and 0.5% NaCl, 0.08% Na2HPO4, 0.036% KH2PO4, WFI, and 0.4% phenol as a preservative. Although extracts from whole pelts of cats are similar in content of Fel d 1 to extracts prepared only from wash, hair and dander, pelt extracts may contain other non-Fel d 1 allergenic molecules."
},
{
"NDCCode": "70771-1121-6",
"PackageDescription": "10 VIAL in 1 CARTON (70771-1121-6) > 10 mL in 1 VIAL (70771-1121-1) ",
"NDC11Code": "70771-1121-06",
"ProductNDC": "70771-1121",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline",
"NonProprietaryName": "Doxycycline",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20180201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207757",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2022-11-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180201",
"SamplePackage": "N"
},
{
"NDCCode": "71335-1121-8",
"PackageDescription": "10 TABLET, FILM COATED in 1 BOTTLE (71335-1121-8) ",
"NDC11Code": "71335-1121-08",
"ProductNDC": "71335-1121",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydroxyzine Hydrochloride",
"NonProprietaryName": "Hydroxyzine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040600",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "HYDROXYZINE DIHYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2024-04-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190307",
"SamplePackage": "N",
"IndicationAndUsage": "For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus. As a sedative when used as a premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.",
"Description": "Hydroxyzine hydrochloride, USP has the chemical name of 2-[2-[4-( p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride. C21H27CIN2O2·2HCl. M.W. 447.83. Hydroxyzine hydrochloride, USP occurs as a white, odorless powder which is very soluble in water. Each tablet for oral administration contains 10 mg, 25 mg or 50 mg hydroxyzine hydrochloride, USP. Inactive ingredients include carnauba wax, colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, D&C Yellow #10 Aluminum Lake (25 mg and 50 mg), FD&C Blue #2 Aluminum Lake (25 mg), FD&C Red #40 Aluminum Lake (50 mg), FD&C Yellow #6 Aluminum Lake (10 mg and 50 mg), hypromellose, polyethylene glycol 3350, polyvinyl alcohol, talc, titanium dioxide, triacetin and yellow iron oxide (10 mg)."
},
{
"NDCCode": "85512-1121-3",
"PackageDescription": "10 g in 1 BOTTLE (85512-1121-3) ",
"NDC11Code": "85512-1121-03",
"ProductNDC": "85512-1121",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Dulaglutide",
"DosageFormName": "POWDER",
"StartMarketingDate": "20250602",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Qingdao Qinzeyuan Biotechnology Co., Ltd",
"SubstanceName": "DULAGLUTIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "02-JUN-25"
},
{
"NDCCode": "0268-1121-50",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (0268-1121-50) ",
"NDC11Code": "00268-1121-50",
"ProductNDC": "0268-1121",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Zea Mays Pollen",
"NonProprietaryName": "Corn Pollen",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "19650101",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103753",
"LabelerName": "ALK-Abello, Inc.",
"SubstanceName": "ZEA MAYS POLLEN",
"StrengthNumber": ".05",
"StrengthUnit": "g/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]",
"Status": "Active",
"LastUpdate": "2023-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19650101",
"SamplePackage": "N",
"IndicationAndUsage": "Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust, molds, animal danders, various other inhalants, and in situations where the offending allergen cannot be avoided. Prior to initiation of therapy, the clinical sensitivity should be established by careful evaluation of the patient’s history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can easily be avoided.",
"Description": "Sterile therapeutic extracts are supplied in either Phenol Saline Diluent or in Diluent containing Glycerin 50% (v/v) for subcutaneous injection. Inactive ingredients may include: Sodium Chloride for isotonicity, Glycerin, and Sodium Bicarbonate as buffering agents. These products are compounded and diluted on a w/v or PNU basis. Pollens are individually extracted from pure pollen extracted in a phenol-preserved sodium bicarbonate solution. Short Ragweed and Mixed (Tall and Short) Ragweed extracts are standardized by Antigen E content and so labeled. The Antigen E content of extracts containing Short Ragweed at a concentration more dilute than a weight/volume ratio of 1:10 are obtained by calculating the Antigen E content based on the assay value of more concentrated extract. Pollen extracts are filtered aseptically and, after final packaging, they are tested for sterility and safety. Molds are individually extracted from pure powdered inactivated mold source material extracted in phenol preserved saline. Mold extracts are filtered aseptically and after final packaging are tested for sterility and safety. Molds are present in all inhabited places at all seasons of the year; they are so ubiquitous that they are prevalent at times when common allergic pollens and other inhalants are not. In the home and surroundings, molds are found in upholstered furniture, mattresses, drapes, cellar and storage room dust, woolens, leather goods, fruits, meats, cheeses, garden soil and on plants. Spores, mycelial fragments and mold residues are thus inhaled, contacted and ingested continuously. Miscellaneous inhalants and epidermals are individually extracted in phenol preserved saline, filtered aseptically and after final packaging are tested for sterility and safety."
},
{
"NDCCode": "0363-1121-03",
"PackageDescription": "89 mL in 1 TUBE (0363-1121-03) ",
"NDC11Code": "00363-1121-03",
"ProductNDC": "0363-1121",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hydrating Spf 50",
"NonProprietaryName": "Avobenzone 3% Homosalate 15% Octisalate 5% Octocrylene 10%",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20161116",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Walgreens",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "3; 15; 5; 10",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20161116",
"SamplePackage": "N",
"IndicationAndUsage": "Uses helps prevent sunburn higher SPF gives more sunburnprotection retains SPF after 80 minutes of activity in the water orsweating provides high protection against sunburn."
},
{
"NDCCode": "0363-1121-06",
"PackageDescription": "236 mL in 1 CAN (0363-1121-06) ",
"NDC11Code": "00363-1121-06",
"ProductNDC": "0363-1121",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hydrating Spf 50",
"NonProprietaryName": "Avobenzone 3% Homosalate 15% Octisalate 5% Octocrylene 10%",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20161116",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Walgreens",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "3; 15; 5; 10",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20161116",
"SamplePackage": "N",
"IndicationAndUsage": "Uses helps prevent sunburn higher SPF gives more sunburnprotection retains SPF after 80 minutes of activity in the water orsweating provides high protection against sunburn."
},
{
"NDCCode": "0363-1121-07",
"PackageDescription": "296 mL in 1 TUBE (0363-1121-07) ",
"NDC11Code": "00363-1121-07",
"ProductNDC": "0363-1121",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hydrating Spf 50",
"NonProprietaryName": "Avobenzone 3% Homosalate 15% Octisalate 5% Octocrylene 10%",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20161116",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Walgreens",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "3; 15; 5; 10",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20161116",
"SamplePackage": "N",
"IndicationAndUsage": "Uses helps prevent sunburn higher SPF gives more sunburnprotection retains SPF after 80 minutes of activity in the water orsweating provides high protection against sunburn."
},
{
"NDCCode": "11822-1121-0",
"PackageDescription": "1 BOTTLE in 1 CARTON (11822-1121-0) > 20 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "11822-1121-00",
"ProductNDC": "11822-1121",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Migraine Relief",
"NonProprietaryName": "Acetaminophen, Aspirin, Caffeine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220308",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075794",
"LabelerName": "Rite Aid Corporation",
"SubstanceName": "ACETAMINOPHEN; ASPIRIN; CAFFEINE",
"StrengthNumber": "250; 250; 65",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20220308",
"SamplePackage": "N",
"IndicationAndUsage": "treats migraine."
},
{
"NDCCode": "24584-1121-1",
"PackageDescription": "57692 TABLET, FILM COATED in 1 CONTAINER (24584-1121-1) ",
"NDC11Code": "24584-1121-01",
"ProductNDC": "24584-1121",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Ocaliva",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20230201",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Piramal Healthcare UK Limited",
"SubstanceName": "OBETICHOLIC ACID",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2024-02-10",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "01-FEB-23"
},
{
"NDCCode": "36987-1121-1",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (36987-1121-1)",
"NDC11Code": "36987-1121-01",
"ProductNDC": "36987-1121",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Standardized Cat Hair",
"NonProprietaryName": "Standardized Cat Hair",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19920929",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103384",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "FELIS CATUS HAIR",
"StrengthNumber": "10000",
"StrengthUnit": "[BAU]/mL",
"Pharm_Classes": "Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [CS],Allergens [CS],Salivary Proteins and Peptides [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Standardized Cat Hair is intended for use in the diagnosis and therapy of cat allergy patients as established by allergy history and skin test reactivity.",
"Description": "Standardized cat hair extract is a sterile glycerinated injectable solution containing the extractables of dried, powdered cat hair, wash and dander and 0.5% NaCl, 0.08% Na2HPO4, 0.036% KH2PO4, water for injection and 0.4%, phenol as preservative in sterile containers. All extracts are aseptically filled. Standardized cat hair extract is to be administered by prick-puncture or intradermal routes when used for diagnostic purposes and administered subcutaneously when used for immunotherapy injections. The Bioequivalent Allergy Unit (BAU) nomenclature, now used for all Standardized Cat Extracts, replaces the previous Allergy Unit (AU) nomenclature for these products. Bioequivalent Allergy Units are based on quantitative intradermal skin test results and are intended to assure that the labeled unit of different allergenic extracts will correspond to the expected clinical response in sensitive patients. References labeled 10,000 BAU/mL can be diluted to one half million fold to produce an intradermal sum of erythema diameter response of 50 mm in highly puncture reactive subjects. In vitro assignment of BAU/mL to this product is based on radial immunodiffusion (RID) assay results according to guidelines established by the Center for Biologics Evaluation and Research (CBER) as indicated below.(5, 6). Bioequivalent Allergy Units (BAU) are NOT interchangeable with Allergy Units (AU). Standardized Cat Hair extract labeled in BAU/mL are not interchangeable with standardized cat pelt extracts or with cat hair extracts labeled in AU/mL or with non-standardized cat hair extracts. It has been recognized through investigation that the allergens responsible for Cat allergy are found in the pelt, hair, dander, saliva, serum and urine.(1) Saliva especially when deposited on and in combination with the hair, root hairs and skin can produce a significant allergic reaction. Repeated surface washing of the animal proved significant enough so that the wash was added to the whole of the raw material producing the cat allergenic extract.(2,3,4) However the amount of Fel d 1 varies widely from animal to animal so it is an advantage to use raw material with a known amount of the antigen. Nelco's raw material, supplied by Biopol Laboratory, is dried, powdered cat hair, wash and dander, labeled with the number of Fel d 1 units in each gram of dried material per container. The raw material is extracted with a 50%(v/v) glycerinated diluent containing glycerin and 0.5% NaCl, 0.08% Na2HPO4, 0.036% KH2PO4, WFI, and 0.4% phenol as a preservative. Although extracts from whole pelts of cats are similar in content of Fel d 1 to extracts prepared only from wash, hair and dander, pelt extracts may contain other non-Fel d 1 allergenic molecules."
},
{
"NDCCode": "36987-1121-3",
"PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (36987-1121-3)",
"NDC11Code": "36987-1121-03",
"ProductNDC": "36987-1121",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Standardized Cat Hair",
"NonProprietaryName": "Standardized Cat Hair",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19920929",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103384",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "FELIS CATUS HAIR",
"StrengthNumber": "10000",
"StrengthUnit": "[BAU]/mL",
"Pharm_Classes": "Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [CS],Allergens [CS],Salivary Proteins and Peptides [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Standardized Cat Hair is intended for use in the diagnosis and therapy of cat allergy patients as established by allergy history and skin test reactivity.",
"Description": "Standardized cat hair extract is a sterile glycerinated injectable solution containing the extractables of dried, powdered cat hair, wash and dander and 0.5% NaCl, 0.08% Na2HPO4, 0.036% KH2PO4, water for injection and 0.4%, phenol as preservative in sterile containers. All extracts are aseptically filled. Standardized cat hair extract is to be administered by prick-puncture or intradermal routes when used for diagnostic purposes and administered subcutaneously when used for immunotherapy injections. The Bioequivalent Allergy Unit (BAU) nomenclature, now used for all Standardized Cat Extracts, replaces the previous Allergy Unit (AU) nomenclature for these products. Bioequivalent Allergy Units are based on quantitative intradermal skin test results and are intended to assure that the labeled unit of different allergenic extracts will correspond to the expected clinical response in sensitive patients. References labeled 10,000 BAU/mL can be diluted to one half million fold to produce an intradermal sum of erythema diameter response of 50 mm in highly puncture reactive subjects. In vitro assignment of BAU/mL to this product is based on radial immunodiffusion (RID) assay results according to guidelines established by the Center for Biologics Evaluation and Research (CBER) as indicated below.(5, 6). Bioequivalent Allergy Units (BAU) are NOT interchangeable with Allergy Units (AU). Standardized Cat Hair extract labeled in BAU/mL are not interchangeable with standardized cat pelt extracts or with cat hair extracts labeled in AU/mL or with non-standardized cat hair extracts. It has been recognized through investigation that the allergens responsible for Cat allergy are found in the pelt, hair, dander, saliva, serum and urine.(1) Saliva especially when deposited on and in combination with the hair, root hairs and skin can produce a significant allergic reaction. Repeated surface washing of the animal proved significant enough so that the wash was added to the whole of the raw material producing the cat allergenic extract.(2,3,4) However the amount of Fel d 1 varies widely from animal to animal so it is an advantage to use raw material with a known amount of the antigen. Nelco's raw material, supplied by Biopol Laboratory, is dried, powdered cat hair, wash and dander, labeled with the number of Fel d 1 units in each gram of dried material per container. The raw material is extracted with a 50%(v/v) glycerinated diluent containing glycerin and 0.5% NaCl, 0.08% Na2HPO4, 0.036% KH2PO4, WFI, and 0.4% phenol as a preservative. Although extracts from whole pelts of cats are similar in content of Fel d 1 to extracts prepared only from wash, hair and dander, pelt extracts may contain other non-Fel d 1 allergenic molecules."
},
{
"NDCCode": "36987-1121-4",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (36987-1121-4)",
"NDC11Code": "36987-1121-04",
"ProductNDC": "36987-1121",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Standardized Cat Hair",
"NonProprietaryName": "Standardized Cat Hair",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19920929",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103384",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "FELIS CATUS HAIR",
"StrengthNumber": "10000",
"StrengthUnit": "[BAU]/mL",
"Pharm_Classes": "Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [CS],Allergens [CS],Salivary Proteins and Peptides [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Standardized Cat Hair is intended for use in the diagnosis and therapy of cat allergy patients as established by allergy history and skin test reactivity.",
"Description": "Standardized cat hair extract is a sterile glycerinated injectable solution containing the extractables of dried, powdered cat hair, wash and dander and 0.5% NaCl, 0.08% Na2HPO4, 0.036% KH2PO4, water for injection and 0.4%, phenol as preservative in sterile containers. All extracts are aseptically filled. Standardized cat hair extract is to be administered by prick-puncture or intradermal routes when used for diagnostic purposes and administered subcutaneously when used for immunotherapy injections. The Bioequivalent Allergy Unit (BAU) nomenclature, now used for all Standardized Cat Extracts, replaces the previous Allergy Unit (AU) nomenclature for these products. Bioequivalent Allergy Units are based on quantitative intradermal skin test results and are intended to assure that the labeled unit of different allergenic extracts will correspond to the expected clinical response in sensitive patients. References labeled 10,000 BAU/mL can be diluted to one half million fold to produce an intradermal sum of erythema diameter response of 50 mm in highly puncture reactive subjects. In vitro assignment of BAU/mL to this product is based on radial immunodiffusion (RID) assay results according to guidelines established by the Center for Biologics Evaluation and Research (CBER) as indicated below.(5, 6). Bioequivalent Allergy Units (BAU) are NOT interchangeable with Allergy Units (AU). Standardized Cat Hair extract labeled in BAU/mL are not interchangeable with standardized cat pelt extracts or with cat hair extracts labeled in AU/mL or with non-standardized cat hair extracts. It has been recognized through investigation that the allergens responsible for Cat allergy are found in the pelt, hair, dander, saliva, serum and urine.(1) Saliva especially when deposited on and in combination with the hair, root hairs and skin can produce a significant allergic reaction. Repeated surface washing of the animal proved significant enough so that the wash was added to the whole of the raw material producing the cat allergenic extract.(2,3,4) However the amount of Fel d 1 varies widely from animal to animal so it is an advantage to use raw material with a known amount of the antigen. Nelco's raw material, supplied by Biopol Laboratory, is dried, powdered cat hair, wash and dander, labeled with the number of Fel d 1 units in each gram of dried material per container. The raw material is extracted with a 50%(v/v) glycerinated diluent containing glycerin and 0.5% NaCl, 0.08% Na2HPO4, 0.036% KH2PO4, WFI, and 0.4% phenol as a preservative. Although extracts from whole pelts of cats are similar in content of Fel d 1 to extracts prepared only from wash, hair and dander, pelt extracts may contain other non-Fel d 1 allergenic molecules."
},
{
"NDCCode": "54569-1121-0",
"PackageDescription": "1 TUBE in 1 CARTON (54569-1121-0) > 15 g in 1 TUBE",
"NDC11Code": "54569-1121-00",
"ProductNDC": "54569-1121",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19780309",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085692",
"LabelerName": "A-S Medication Solutions LLC",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0009-0280-03",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (0009-0280-03) ",
"NDC11Code": "00009-0280-03",
"ProductNDC": "0009-0280",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Depo-medrol",
"NonProprietaryName": "Methylprednisolone Acetate",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE",
"StartMarketingDate": "19590528",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA011757",
"LabelerName": "Pharmacia & Upjohn Company LLC",
"SubstanceName": "METHYLPREDNISOLONE ACETATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19590528",
"SamplePackage": "N",
"IndicationAndUsage": "When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intramuscular use of DEPO-MEDROL Sterile Aqueous Suspension is indicated as follows. Allergic States: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic Diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal Diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic Disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), pure red cell aplasia, select cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic Diseases: For palliative management of leukemias and lymphomas. Nervous System: Cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic Diseases: Sympathetic ophthalmia, temporal arteritis, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal Diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus. Respiratory Diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic Disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.",
"Description": "DEPO-MEDROL is an anti-inflammatory glucocorticoid for intramuscular, intra-articular, soft tissue, or intralesional injection. It is available in three strengths: 20 mg/mL, 40 mg/mL, 80 mg/mL. Each mL of these preparations contains. Sodium Chloride was added to adjust tonicity. When necessary, pH was adjusted with sodium hydroxide and/or hydrochloric acid. The pH of the finished product remains within the USP specified range (e.g., 3.5 to 7.0). The chemical name for methylprednisolone acetate is pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-11,17-dihydroxy-6-methyl-,(6α,11ß)- and the molecular weight is 416.51. The structural formula is represented below. DEPO-MEDROL Sterile Aqueous Suspension contains methylprednisolone acetate which is the 6-methyl derivative of prednisolone. Methylprednisolone acetate is a white or practically white, odorless, crystalline powder which melts at about 215° with some decomposition. It is soluble in dioxane, sparingly soluble in acetone, alcohol, chloroform, and methanol, and slightly soluble in ether. It is practically insoluble in water."
},
{
"NDCCode": "0009-0280-25",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (0009-0280-25) ",
"NDC11Code": "00009-0280-25",
"ProductNDC": "0009-0280",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Depo-medrol",
"NonProprietaryName": "Methylprednisolone Acetate",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE",
"StartMarketingDate": "19590528",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA011757",
"LabelerName": "Pharmacia and Upjohn Company LLC",
"SubstanceName": "METHYLPREDNISOLONE ACETATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-12-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "19590528",
"SamplePackage": "N"
},
{
"NDCCode": "0009-0280-52",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 PACKAGE (0009-0280-52) / 10 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00009-0280-52",
"ProductNDC": "0009-0280",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Depo-medrol",
"NonProprietaryName": "Methylprednisolone Acetate",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE",
"StartMarketingDate": "19590528",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA011757",
"LabelerName": "Pharmacia & Upjohn Company LLC",
"SubstanceName": "METHYLPREDNISOLONE ACETATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19590528",
"SamplePackage": "N",
"IndicationAndUsage": "When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intramuscular use of DEPO-MEDROL Sterile Aqueous Suspension is indicated as follows. Allergic States: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic Diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal Diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic Disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), pure red cell aplasia, select cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic Diseases: For palliative management of leukemias and lymphomas. Nervous System: Cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic Diseases: Sympathetic ophthalmia, temporal arteritis, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal Diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus. Respiratory Diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic Disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.",
"Description": "DEPO-MEDROL is an anti-inflammatory glucocorticoid for intramuscular, intra-articular, soft tissue, or intralesional injection. It is available in three strengths: 20 mg/mL, 40 mg/mL, 80 mg/mL. Each mL of these preparations contains. Sodium Chloride was added to adjust tonicity. When necessary, pH was adjusted with sodium hydroxide and/or hydrochloric acid. The pH of the finished product remains within the USP specified range (e.g., 3.5 to 7.0). The chemical name for methylprednisolone acetate is pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-11,17-dihydroxy-6-methyl-,(6α,11ß)- and the molecular weight is 416.51. The structural formula is represented below. DEPO-MEDROL Sterile Aqueous Suspension contains methylprednisolone acetate which is the 6-methyl derivative of prednisolone. Methylprednisolone acetate is a white or practically white, odorless, crystalline powder which melts at about 215° with some decomposition. It is soluble in dioxane, sparingly soluble in acetone, alcohol, chloroform, and methanol, and slightly soluble in ether. It is practically insoluble in water."
},
{
"NDCCode": "0268-0280-10",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (0268-0280-10) ",
"NDC11Code": "00268-0280-10",
"ProductNDC": "0268-0280",
"ProductTypeName": "STANDARDIZED ALLERGENIC",
"ProprietaryName": "Timothy, Standardized",
"NonProprietaryName": "Timothy, Standardized",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "19971218",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103058",
"LabelerName": "ALK-Abello, Inc.",
"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": "Deprecated",
"LastUpdate": "2023-05-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "19971218",
"SamplePackage": "N"
},
{
"NDCCode": "0280-0001-04",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (0280-0001-04) / 10 GUM, CHEWING in 1 BLISTER PACK",
"NDC11Code": "00280-0001-04",
"ProductNDC": "0280-0001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alka-seltzer Cool Action Heartburn Relief",
"ProprietaryNameSuffix": "Mint",
"NonProprietaryName": "Calcium Carbonate",
"DosageFormName": "GUM, CHEWING",
"RouteName": "ORAL",
"StartMarketingDate": "20200301",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M001",
"LabelerName": "Bayer HealthCare LLC.",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241115",
"SamplePackage": "N",
"IndicationAndUsage": "Uses for the relief of:. ● acid indigestion ● heartburn ● sour stomach. ● upset stomach associated with these symptoms."
},
{
"NDCCode": "0280-0020-01",
"PackageDescription": "10 POUCH in 1 CARTON (0280-0020-01) / 2 TABLET, EFFERVESCENT in 1 POUCH",
"NDC11Code": "00280-0020-01",
"ProductNDC": "0280-0020",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alka-seltzer Plus Severe Cold Powerfast Fizz",
"ProprietaryNameSuffix": "Orange Zest",
"NonProprietaryName": "Aspirin, Chlorpheniramine Maleate, Phenylephrine Bitartrate",
"DosageFormName": "TABLET, EFFERVESCENT",
"RouteName": "ORAL",
"StartMarketingDate": "20200701",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Bayer HealthCare LLC.",
"SubstanceName": "PHENYLEPHRINE BITARTRATE; CHLORPHENIRAMINE MALEATE; ASPIRIN",
"StrengthNumber": "7; 2; 325",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20200701",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. · temporarily relieves these symptoms due to a cold. · minor aches and pains · headache · runny nose. · nasal and sinus congestion · sneezing · sore throat. · temporarily reduces fever."
},
{
"NDCCode": "0280-0021-01",
"PackageDescription": "10 POUCH in 1 CARTON (0280-0021-01) / 2 TABLET, EFFERVESCENT in 1 POUCH",
"NDC11Code": "00280-0021-01",
"ProductNDC": "0280-0021",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alka-seltzer Plus Severe Cold Powerfast Fizz Night",
"NonProprietaryName": "Aspirin, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Bitartrate",
"DosageFormName": "TABLET, EFFERVESCENT",
"RouteName": "ORAL",
"StartMarketingDate": "20200401",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Bayer HealthCare LLC.",
"SubstanceName": "ASPIRIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE BITARTRATE; DOXYLAMINE SUCCINATE",
"StrengthNumber": "500; 10; 7.8; 6.25",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Antihistamine [EPC], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Histamine Receptor Antagonists [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200401",
"SamplePackage": "N",
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},
{
"NDCCode": "0280-0022-01",
"PackageDescription": "10 POUCH in 1 CARTON (0280-0022-01) / 2 TABLET, EFFERVESCENT in 1 POUCH",
"NDC11Code": "00280-0022-01",
"ProductNDC": "0280-0022",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alka-seltzer Plus Severe Cold And Flu Powerfast Fizz",
"NonProprietaryName": "Chlorpheniramine Maleate, Acetaminophen, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide",
"DosageFormName": "TABLET, EFFERVESCENT",
"RouteName": "ORAL",
"StartMarketingDate": "20200401",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Bayer HealthCare LLC.",
"SubstanceName": "ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "250; 2; 10; 5",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200401",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. · temporarily relieves these symptoms due to a cold or flu. · minor aches and pains · headache · cough. · sore throat · runny nose · sneezing. · nasal and sinus congestion. · temporarily reduces fever."
},
{
"NDCCode": "0280-0023-01",
"PackageDescription": "10 POUCH in 1 CARTON (0280-0023-01) / 2 TABLET, EFFERVESCENT in 1 POUCH",
"NDC11Code": "00280-0023-01",
"ProductNDC": "0280-0023",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alka-seltzer Plus Severe Cold And Cough Powerfast Fizz",
"NonProprietaryName": "Aspirin, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Bitartrate",
"DosageFormName": "TABLET, EFFERVESCENT",
"RouteName": "ORAL",
"StartMarketingDate": "20200401",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Bayer Healthcare LLC.",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE",
"StrengthNumber": "10; 325; 2; 7.8",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200401",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. · temporarily relieves these symptoms due to a cold with cough. · minor aches and pains · headache · cough. · runny nose · nasal and sinus congestion. · sneezing · sore throat. · temporarily reduces fever."
},
{
"NDCCode": "0280-0024-01",
"PackageDescription": "10 POUCH in 1 CARTON (0280-0024-01) / 2 TABLET, EFFERVESCENT in 1 POUCH",
"NDC11Code": "00280-0024-01",
"ProductNDC": "0280-0024",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alka-seltzer Plus Severe Cold Powerfast Fizz Non Drowsy",
"NonProprietaryName": "Asprin, Dextromethorphan Hydrobromide, Phenylephrine Bitartrate",
"DosageFormName": "TABLET, EFFERVESCENT",
"RouteName": "ORAL",
"StartMarketingDate": "20200401",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Bayer HealthCare LLC.",
"SubstanceName": "ASPIRIN; PHENYLEPHRINE BITARTRATE; DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "325; 7.8; 10",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200430",
"SamplePackage": "N"
}
]
}
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<NDC>
<NDCCode>0280-1121-10</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (0280-1121-10) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00280-1121-10</NDC11Code>
<ProductNDC>0280-1121</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alka-seltzer Plus</ProprietaryName>
<ProprietaryNameSuffix>Cold And Cough Formula</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131030</StartMarketingDate>
<EndMarketingDate>20190430</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Bayer HealthCare LLC.</LabelerName>
<SubstanceName>ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 2; 10; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-05-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>0280-1121-20</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (0280-1121-20) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00280-1121-20</NDC11Code>
<ProductNDC>0280-1121</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alka-seltzer Plus</ProprietaryName>
<ProprietaryNameSuffix>Cold And Cough Formula</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131030</StartMarketingDate>
<EndMarketingDate>20190430</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Bayer HealthCare LLC.</LabelerName>
<SubstanceName>ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 2; 10; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-05-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>0280-1121-40</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (0280-1121-40) > 40 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00280-1121-40</NDC11Code>
<ProductNDC>0280-1121</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alka-seltzer Plus</ProprietaryName>
<ProprietaryNameSuffix>Cold And Cough Formula</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131030</StartMarketingDate>
<EndMarketingDate>20190430</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Bayer HealthCare LLC.</LabelerName>
<SubstanceName>ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 2; 10; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-05-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>0115-1121-10</NDCCode>
<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1121-10)</PackageDescription>
<NDC11Code>00115-1121-10</NDC11Code>
<ProductNDC>0115-1121</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Galantamine Hydrobromide</ProprietaryName>
<NonProprietaryName>Galantamine Hydrobromide</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090527</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078484</ApplicationNumber>
<LabelerName>Global Pharmaceuticals, Division of Impax Laboratories Inc.</LabelerName>
<SubstanceName>GALANTAMINE HYDROBROMIDE</SubstanceName>
<StrengthNumber>16</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-04-13</LastUpdate>
</NDC>
<NDC>
<NDCCode>0268-1121-10</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (0268-1121-10) </PackageDescription>
<NDC11Code>00268-1121-10</NDC11Code>
<ProductNDC>0268-1121</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Zea Mays Pollen</ProprietaryName>
<NonProprietaryName>Corn Pollen</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>19650101</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103753</ApplicationNumber>
<LabelerName>ALK-Abello, Inc.</LabelerName>
<SubstanceName>ZEA MAYS POLLEN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/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]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19650101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust, molds, animal danders, various other inhalants, and in situations where the offending allergen cannot be avoided. Prior to initiation of therapy, the clinical sensitivity should be established by careful evaluation of the patient’s history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can easily be avoided.</IndicationAndUsage>
<Description>Sterile therapeutic extracts are supplied in either Phenol Saline Diluent or in Diluent containing Glycerin 50% (v/v) for subcutaneous injection. Inactive ingredients may include: Sodium Chloride for isotonicity, Glycerin, and Sodium Bicarbonate as buffering agents. These products are compounded and diluted on a w/v or PNU basis. Pollens are individually extracted from pure pollen extracted in a phenol-preserved sodium bicarbonate solution. Short Ragweed and Mixed (Tall and Short) Ragweed extracts are standardized by Antigen E content and so labeled. The Antigen E content of extracts containing Short Ragweed at a concentration more dilute than a weight/volume ratio of 1:10 are obtained by calculating the Antigen E content based on the assay value of more concentrated extract. Pollen extracts are filtered aseptically and, after final packaging, they are tested for sterility and safety. Molds are individually extracted from pure powdered inactivated mold source material extracted in phenol preserved saline. Mold extracts are filtered aseptically and after final packaging are tested for sterility and safety. Molds are present in all inhabited places at all seasons of the year; they are so ubiquitous that they are prevalent at times when common allergic pollens and other inhalants are not. In the home and surroundings, molds are found in upholstered furniture, mattresses, drapes, cellar and storage room dust, woolens, leather goods, fruits, meats, cheeses, garden soil and on plants. Spores, mycelial fragments and mold residues are thus inhaled, contacted and ingested continuously. Miscellaneous inhalants and epidermals are individually extracted in phenol preserved saline, filtered aseptically and after final packaging are tested for sterility and safety.</Description>
</NDC>
<NDC>
<NDCCode>22840-1121-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (22840-1121-2) </PackageDescription>
<NDC11Code>22840-1121-02</NDC11Code>
<ProductNDC>22840-1121</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Hog Epithelia</ProprietaryName>
<NonProprietaryName>Sus Scrofa</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19810915</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101833</ApplicationNumber>
<LabelerName>Greer Laboratories, Inc.</LabelerName>
<SubstanceName>SUS SCROFA SKIN</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Cells, Epidermal [EXT], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Animal Skin Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19810915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Non-Standardized Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens., 2 Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies. .</IndicationAndUsage>
<Description>Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter.</Description>
</NDC>
<NDC>
<NDCCode>36987-1121-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (36987-1121-2)</PackageDescription>
<NDC11Code>36987-1121-02</NDC11Code>
<ProductNDC>36987-1121</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Standardized Cat Hair</ProprietaryName>
<NonProprietaryName>Standardized Cat Hair</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19920929</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103384</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>FELIS CATUS HAIR</SubstanceName>
<StrengthNumber>10000</StrengthNumber>
<StrengthUnit>[BAU]/mL</StrengthUnit>
<Pharm_Classes>Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [CS],Allergens [CS],Salivary Proteins and Peptides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Standardized Cat Hair is intended for use in the diagnosis and therapy of cat allergy patients as established by allergy history and skin test reactivity.</IndicationAndUsage>
<Description>Standardized cat hair extract is a sterile glycerinated injectable solution containing the extractables of dried, powdered cat hair, wash and dander and 0.5% NaCl, 0.08% Na2HPO4, 0.036% KH2PO4, water for injection and 0.4%, phenol as preservative in sterile containers. All extracts are aseptically filled. Standardized cat hair extract is to be administered by prick-puncture or intradermal routes when used for diagnostic purposes and administered subcutaneously when used for immunotherapy injections. The Bioequivalent Allergy Unit (BAU) nomenclature, now used for all Standardized Cat Extracts, replaces the previous Allergy Unit (AU) nomenclature for these products. Bioequivalent Allergy Units are based on quantitative intradermal skin test results and are intended to assure that the labeled unit of different allergenic extracts will correspond to the expected clinical response in sensitive patients. References labeled 10,000 BAU/mL can be diluted to one half million fold to produce an intradermal sum of erythema diameter response of 50 mm in highly puncture reactive subjects. In vitro assignment of BAU/mL to this product is based on radial immunodiffusion (RID) assay results according to guidelines established by the Center for Biologics Evaluation and Research (CBER) as indicated below.(5, 6). Bioequivalent Allergy Units (BAU) are NOT interchangeable with Allergy Units (AU). Standardized Cat Hair extract labeled in BAU/mL are not interchangeable with standardized cat pelt extracts or with cat hair extracts labeled in AU/mL or with non-standardized cat hair extracts. It has been recognized through investigation that the allergens responsible for Cat allergy are found in the pelt, hair, dander, saliva, serum and urine.(1) Saliva especially when deposited on and in combination with the hair, root hairs and skin can produce a significant allergic reaction. Repeated surface washing of the animal proved significant enough so that the wash was added to the whole of the raw material producing the cat allergenic extract.(2,3,4) However the amount of Fel d 1 varies widely from animal to animal so it is an advantage to use raw material with a known amount of the antigen. Nelco's raw material, supplied by Biopol Laboratory, is dried, powdered cat hair, wash and dander, labeled with the number of Fel d 1 units in each gram of dried material per container. The raw material is extracted with a 50%(v/v) glycerinated diluent containing glycerin and 0.5% NaCl, 0.08% Na2HPO4, 0.036% KH2PO4, WFI, and 0.4% phenol as a preservative. Although extracts from whole pelts of cats are similar in content of Fel d 1 to extracts prepared only from wash, hair and dander, pelt extracts may contain other non-Fel d 1 allergenic molecules.</Description>
</NDC>
<NDC>
<NDCCode>70771-1121-6</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (70771-1121-6) > 10 mL in 1 VIAL (70771-1121-1) </PackageDescription>
<NDC11Code>70771-1121-06</NDC11Code>
<ProductNDC>70771-1121</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline</ProprietaryName>
<NonProprietaryName>Doxycycline</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20180201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207757</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-11-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71335-1121-8</NDCCode>
<PackageDescription>10 TABLET, FILM COATED in 1 BOTTLE (71335-1121-8) </PackageDescription>
<NDC11Code>71335-1121-08</NDC11Code>
<ProductNDC>71335-1121</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydroxyzine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydroxyzine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150331</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040600</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>HYDROXYZINE DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-04-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190307</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus. As a sedative when used as a premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Hydroxyzine hydrochloride, USP has the chemical name of 2-[2-[4-( p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride. C21H27CIN2O2·2HCl. M.W. 447.83. Hydroxyzine hydrochloride, USP occurs as a white, odorless powder which is very soluble in water. Each tablet for oral administration contains 10 mg, 25 mg or 50 mg hydroxyzine hydrochloride, USP. Inactive ingredients include carnauba wax, colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, D&C Yellow #10 Aluminum Lake (25 mg and 50 mg), FD&C Blue #2 Aluminum Lake (25 mg), FD&C Red #40 Aluminum Lake (50 mg), FD&C Yellow #6 Aluminum Lake (10 mg and 50 mg), hypromellose, polyethylene glycol 3350, polyvinyl alcohol, talc, titanium dioxide, triacetin and yellow iron oxide (10 mg).</Description>
</NDC>
<NDC>
<NDCCode>85512-1121-3</NDCCode>
<PackageDescription>10 g in 1 BOTTLE (85512-1121-3) </PackageDescription>
<NDC11Code>85512-1121-03</NDC11Code>
<ProductNDC>85512-1121</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Dulaglutide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20250602</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Qingdao Qinzeyuan Biotechnology Co., Ltd</LabelerName>
<SubstanceName>DULAGLUTIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>02-JUN-25</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>0268-1121-50</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (0268-1121-50) </PackageDescription>
<NDC11Code>00268-1121-50</NDC11Code>
<ProductNDC>0268-1121</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Zea Mays Pollen</ProprietaryName>
<NonProprietaryName>Corn Pollen</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>19650101</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103753</ApplicationNumber>
<LabelerName>ALK-Abello, Inc.</LabelerName>
<SubstanceName>ZEA MAYS POLLEN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/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]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19650101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hyposensitization (injection) therapy is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust, molds, animal danders, various other inhalants, and in situations where the offending allergen cannot be avoided. Prior to initiation of therapy, the clinical sensitivity should be established by careful evaluation of the patient’s history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can easily be avoided.</IndicationAndUsage>
<Description>Sterile therapeutic extracts are supplied in either Phenol Saline Diluent or in Diluent containing Glycerin 50% (v/v) for subcutaneous injection. Inactive ingredients may include: Sodium Chloride for isotonicity, Glycerin, and Sodium Bicarbonate as buffering agents. These products are compounded and diluted on a w/v or PNU basis. Pollens are individually extracted from pure pollen extracted in a phenol-preserved sodium bicarbonate solution. Short Ragweed and Mixed (Tall and Short) Ragweed extracts are standardized by Antigen E content and so labeled. The Antigen E content of extracts containing Short Ragweed at a concentration more dilute than a weight/volume ratio of 1:10 are obtained by calculating the Antigen E content based on the assay value of more concentrated extract. Pollen extracts are filtered aseptically and, after final packaging, they are tested for sterility and safety. Molds are individually extracted from pure powdered inactivated mold source material extracted in phenol preserved saline. Mold extracts are filtered aseptically and after final packaging are tested for sterility and safety. Molds are present in all inhabited places at all seasons of the year; they are so ubiquitous that they are prevalent at times when common allergic pollens and other inhalants are not. In the home and surroundings, molds are found in upholstered furniture, mattresses, drapes, cellar and storage room dust, woolens, leather goods, fruits, meats, cheeses, garden soil and on plants. Spores, mycelial fragments and mold residues are thus inhaled, contacted and ingested continuously. Miscellaneous inhalants and epidermals are individually extracted in phenol preserved saline, filtered aseptically and after final packaging are tested for sterility and safety.</Description>
</NDC>
<NDC>
<NDCCode>0363-1121-03</NDCCode>
<PackageDescription>89 mL in 1 TUBE (0363-1121-03) </PackageDescription>
<NDC11Code>00363-1121-03</NDC11Code>
<ProductNDC>0363-1121</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hydrating Spf 50</ProprietaryName>
<NonProprietaryName>Avobenzone 3% Homosalate 15% Octisalate 5% Octocrylene 10%</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20161116</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Walgreens</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>3; 15; 5; 10</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161116</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses helps prevent sunburn higher SPF gives more sunburnprotection retains SPF after 80 minutes of activity in the water orsweating provides high protection against sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0363-1121-06</NDCCode>
<PackageDescription>236 mL in 1 CAN (0363-1121-06) </PackageDescription>
<NDC11Code>00363-1121-06</NDC11Code>
<ProductNDC>0363-1121</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hydrating Spf 50</ProprietaryName>
<NonProprietaryName>Avobenzone 3% Homosalate 15% Octisalate 5% Octocrylene 10%</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20161116</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Walgreens</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>3; 15; 5; 10</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161116</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses helps prevent sunburn higher SPF gives more sunburnprotection retains SPF after 80 minutes of activity in the water orsweating provides high protection against sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0363-1121-07</NDCCode>
<PackageDescription>296 mL in 1 TUBE (0363-1121-07) </PackageDescription>
<NDC11Code>00363-1121-07</NDC11Code>
<ProductNDC>0363-1121</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hydrating Spf 50</ProprietaryName>
<NonProprietaryName>Avobenzone 3% Homosalate 15% Octisalate 5% Octocrylene 10%</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20161116</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Walgreens</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>3; 15; 5; 10</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161116</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses helps prevent sunburn higher SPF gives more sunburnprotection retains SPF after 80 minutes of activity in the water orsweating provides high protection against sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11822-1121-0</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (11822-1121-0) > 20 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>11822-1121-00</NDC11Code>
<ProductNDC>11822-1121</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Migraine Relief</ProprietaryName>
<NonProprietaryName>Acetaminophen, Aspirin, Caffeine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220308</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075794</ApplicationNumber>
<LabelerName>Rite Aid Corporation</LabelerName>
<SubstanceName>ACETAMINOPHEN; ASPIRIN; CAFFEINE</SubstanceName>
<StrengthNumber>250; 250; 65</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-10-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220308</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>treats migraine.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>24584-1121-1</NDCCode>
<PackageDescription>57692 TABLET, FILM COATED in 1 CONTAINER (24584-1121-1) </PackageDescription>
<NDC11Code>24584-1121-01</NDC11Code>
<ProductNDC>24584-1121</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Ocaliva</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<StartMarketingDate>20230201</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Piramal Healthcare UK Limited</LabelerName>
<SubstanceName>OBETICHOLIC ACID</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-02-10</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-FEB-23</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>36987-1121-1</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (36987-1121-1)</PackageDescription>
<NDC11Code>36987-1121-01</NDC11Code>
<ProductNDC>36987-1121</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Standardized Cat Hair</ProprietaryName>
<NonProprietaryName>Standardized Cat Hair</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19920929</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103384</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>FELIS CATUS HAIR</SubstanceName>
<StrengthNumber>10000</StrengthNumber>
<StrengthUnit>[BAU]/mL</StrengthUnit>
<Pharm_Classes>Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [CS],Allergens [CS],Salivary Proteins and Peptides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Standardized Cat Hair is intended for use in the diagnosis and therapy of cat allergy patients as established by allergy history and skin test reactivity.</IndicationAndUsage>
<Description>Standardized cat hair extract is a sterile glycerinated injectable solution containing the extractables of dried, powdered cat hair, wash and dander and 0.5% NaCl, 0.08% Na2HPO4, 0.036% KH2PO4, water for injection and 0.4%, phenol as preservative in sterile containers. All extracts are aseptically filled. Standardized cat hair extract is to be administered by prick-puncture or intradermal routes when used for diagnostic purposes and administered subcutaneously when used for immunotherapy injections. The Bioequivalent Allergy Unit (BAU) nomenclature, now used for all Standardized Cat Extracts, replaces the previous Allergy Unit (AU) nomenclature for these products. Bioequivalent Allergy Units are based on quantitative intradermal skin test results and are intended to assure that the labeled unit of different allergenic extracts will correspond to the expected clinical response in sensitive patients. References labeled 10,000 BAU/mL can be diluted to one half million fold to produce an intradermal sum of erythema diameter response of 50 mm in highly puncture reactive subjects. In vitro assignment of BAU/mL to this product is based on radial immunodiffusion (RID) assay results according to guidelines established by the Center for Biologics Evaluation and Research (CBER) as indicated below.(5, 6). Bioequivalent Allergy Units (BAU) are NOT interchangeable with Allergy Units (AU). Standardized Cat Hair extract labeled in BAU/mL are not interchangeable with standardized cat pelt extracts or with cat hair extracts labeled in AU/mL or with non-standardized cat hair extracts. It has been recognized through investigation that the allergens responsible for Cat allergy are found in the pelt, hair, dander, saliva, serum and urine.(1) Saliva especially when deposited on and in combination with the hair, root hairs and skin can produce a significant allergic reaction. Repeated surface washing of the animal proved significant enough so that the wash was added to the whole of the raw material producing the cat allergenic extract.(2,3,4) However the amount of Fel d 1 varies widely from animal to animal so it is an advantage to use raw material with a known amount of the antigen. Nelco's raw material, supplied by Biopol Laboratory, is dried, powdered cat hair, wash and dander, labeled with the number of Fel d 1 units in each gram of dried material per container. The raw material is extracted with a 50%(v/v) glycerinated diluent containing glycerin and 0.5% NaCl, 0.08% Na2HPO4, 0.036% KH2PO4, WFI, and 0.4% phenol as a preservative. Although extracts from whole pelts of cats are similar in content of Fel d 1 to extracts prepared only from wash, hair and dander, pelt extracts may contain other non-Fel d 1 allergenic molecules.</Description>
</NDC>
<NDC>
<NDCCode>36987-1121-3</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (36987-1121-3)</PackageDescription>
<NDC11Code>36987-1121-03</NDC11Code>
<ProductNDC>36987-1121</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Standardized Cat Hair</ProprietaryName>
<NonProprietaryName>Standardized Cat Hair</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19920929</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103384</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>FELIS CATUS HAIR</SubstanceName>
<StrengthNumber>10000</StrengthNumber>
<StrengthUnit>[BAU]/mL</StrengthUnit>
<Pharm_Classes>Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [CS],Allergens [CS],Salivary Proteins and Peptides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Standardized Cat Hair is intended for use in the diagnosis and therapy of cat allergy patients as established by allergy history and skin test reactivity.</IndicationAndUsage>
<Description>Standardized cat hair extract is a sterile glycerinated injectable solution containing the extractables of dried, powdered cat hair, wash and dander and 0.5% NaCl, 0.08% Na2HPO4, 0.036% KH2PO4, water for injection and 0.4%, phenol as preservative in sterile containers. All extracts are aseptically filled. Standardized cat hair extract is to be administered by prick-puncture or intradermal routes when used for diagnostic purposes and administered subcutaneously when used for immunotherapy injections. The Bioequivalent Allergy Unit (BAU) nomenclature, now used for all Standardized Cat Extracts, replaces the previous Allergy Unit (AU) nomenclature for these products. Bioequivalent Allergy Units are based on quantitative intradermal skin test results and are intended to assure that the labeled unit of different allergenic extracts will correspond to the expected clinical response in sensitive patients. References labeled 10,000 BAU/mL can be diluted to one half million fold to produce an intradermal sum of erythema diameter response of 50 mm in highly puncture reactive subjects. In vitro assignment of BAU/mL to this product is based on radial immunodiffusion (RID) assay results according to guidelines established by the Center for Biologics Evaluation and Research (CBER) as indicated below.(5, 6). Bioequivalent Allergy Units (BAU) are NOT interchangeable with Allergy Units (AU). Standardized Cat Hair extract labeled in BAU/mL are not interchangeable with standardized cat pelt extracts or with cat hair extracts labeled in AU/mL or with non-standardized cat hair extracts. It has been recognized through investigation that the allergens responsible for Cat allergy are found in the pelt, hair, dander, saliva, serum and urine.(1) Saliva especially when deposited on and in combination with the hair, root hairs and skin can produce a significant allergic reaction. Repeated surface washing of the animal proved significant enough so that the wash was added to the whole of the raw material producing the cat allergenic extract.(2,3,4) However the amount of Fel d 1 varies widely from animal to animal so it is an advantage to use raw material with a known amount of the antigen. Nelco's raw material, supplied by Biopol Laboratory, is dried, powdered cat hair, wash and dander, labeled with the number of Fel d 1 units in each gram of dried material per container. The raw material is extracted with a 50%(v/v) glycerinated diluent containing glycerin and 0.5% NaCl, 0.08% Na2HPO4, 0.036% KH2PO4, WFI, and 0.4% phenol as a preservative. Although extracts from whole pelts of cats are similar in content of Fel d 1 to extracts prepared only from wash, hair and dander, pelt extracts may contain other non-Fel d 1 allergenic molecules.</Description>
</NDC>
<NDC>
<NDCCode>36987-1121-4</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (36987-1121-4)</PackageDescription>
<NDC11Code>36987-1121-04</NDC11Code>
<ProductNDC>36987-1121</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Standardized Cat Hair</ProprietaryName>
<NonProprietaryName>Standardized Cat Hair</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19920929</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103384</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>FELIS CATUS HAIR</SubstanceName>
<StrengthNumber>10000</StrengthNumber>
<StrengthUnit>[BAU]/mL</StrengthUnit>
<Pharm_Classes>Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [CS],Allergens [CS],Salivary Proteins and Peptides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Standardized Cat Hair is intended for use in the diagnosis and therapy of cat allergy patients as established by allergy history and skin test reactivity.</IndicationAndUsage>
<Description>Standardized cat hair extract is a sterile glycerinated injectable solution containing the extractables of dried, powdered cat hair, wash and dander and 0.5% NaCl, 0.08% Na2HPO4, 0.036% KH2PO4, water for injection and 0.4%, phenol as preservative in sterile containers. All extracts are aseptically filled. Standardized cat hair extract is to be administered by prick-puncture or intradermal routes when used for diagnostic purposes and administered subcutaneously when used for immunotherapy injections. The Bioequivalent Allergy Unit (BAU) nomenclature, now used for all Standardized Cat Extracts, replaces the previous Allergy Unit (AU) nomenclature for these products. Bioequivalent Allergy Units are based on quantitative intradermal skin test results and are intended to assure that the labeled unit of different allergenic extracts will correspond to the expected clinical response in sensitive patients. References labeled 10,000 BAU/mL can be diluted to one half million fold to produce an intradermal sum of erythema diameter response of 50 mm in highly puncture reactive subjects. In vitro assignment of BAU/mL to this product is based on radial immunodiffusion (RID) assay results according to guidelines established by the Center for Biologics Evaluation and Research (CBER) as indicated below.(5, 6). Bioequivalent Allergy Units (BAU) are NOT interchangeable with Allergy Units (AU). Standardized Cat Hair extract labeled in BAU/mL are not interchangeable with standardized cat pelt extracts or with cat hair extracts labeled in AU/mL or with non-standardized cat hair extracts. It has been recognized through investigation that the allergens responsible for Cat allergy are found in the pelt, hair, dander, saliva, serum and urine.(1) Saliva especially when deposited on and in combination with the hair, root hairs and skin can produce a significant allergic reaction. Repeated surface washing of the animal proved significant enough so that the wash was added to the whole of the raw material producing the cat allergenic extract.(2,3,4) However the amount of Fel d 1 varies widely from animal to animal so it is an advantage to use raw material with a known amount of the antigen. Nelco's raw material, supplied by Biopol Laboratory, is dried, powdered cat hair, wash and dander, labeled with the number of Fel d 1 units in each gram of dried material per container. The raw material is extracted with a 50%(v/v) glycerinated diluent containing glycerin and 0.5% NaCl, 0.08% Na2HPO4, 0.036% KH2PO4, WFI, and 0.4% phenol as a preservative. Although extracts from whole pelts of cats are similar in content of Fel d 1 to extracts prepared only from wash, hair and dander, pelt extracts may contain other non-Fel d 1 allergenic molecules.</Description>
</NDC>
<NDC>
<NDCCode>54569-1121-0</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (54569-1121-0) > 15 g in 1 TUBE</PackageDescription>
<NDC11Code>54569-1121-00</NDC11Code>
<ProductNDC>54569-1121</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19780309</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085692</ApplicationNumber>
<LabelerName>A-S Medication Solutions LLC</LabelerName>
<SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0009-0280-03</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (0009-0280-03) </PackageDescription>
<NDC11Code>00009-0280-03</NDC11Code>
<ProductNDC>0009-0280</ProductNDC>
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<ProprietaryName>Depo-medrol</ProprietaryName>
<NonProprietaryName>Methylprednisolone Acetate</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE</RouteName>
<StartMarketingDate>19590528</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA011757</ApplicationNumber>
<LabelerName>Pharmacia & Upjohn Company LLC</LabelerName>
<SubstanceName>METHYLPREDNISOLONE ACETATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19590528</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intramuscular use of DEPO-MEDROL Sterile Aqueous Suspension is indicated as follows. Allergic States: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic Diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal Diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic Disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), pure red cell aplasia, select cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic Diseases: For palliative management of leukemias and lymphomas. Nervous System: Cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic Diseases: Sympathetic ophthalmia, temporal arteritis, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal Diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus. Respiratory Diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic Disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
<Description>DEPO-MEDROL is an anti-inflammatory glucocorticoid for intramuscular, intra-articular, soft tissue, or intralesional injection. It is available in three strengths: 20 mg/mL, 40 mg/mL, 80 mg/mL. Each mL of these preparations contains. Sodium Chloride was added to adjust tonicity. When necessary, pH was adjusted with sodium hydroxide and/or hydrochloric acid. The pH of the finished product remains within the USP specified range (e.g., 3.5 to 7.0). The chemical name for methylprednisolone acetate is pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-11,17-dihydroxy-6-methyl-,(6α,11ß)- and the molecular weight is 416.51. The structural formula is represented below. DEPO-MEDROL Sterile Aqueous Suspension contains methylprednisolone acetate which is the 6-methyl derivative of prednisolone. Methylprednisolone acetate is a white or practically white, odorless, crystalline powder which melts at about 215° with some decomposition. It is soluble in dioxane, sparingly soluble in acetone, alcohol, chloroform, and methanol, and slightly soluble in ether. It is practically insoluble in water.</Description>
</NDC>
<NDC>
<NDCCode>0009-0280-25</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (0009-0280-25) </PackageDescription>
<NDC11Code>00009-0280-25</NDC11Code>
<ProductNDC>0009-0280</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Depo-medrol</ProprietaryName>
<NonProprietaryName>Methylprednisolone Acetate</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE</RouteName>
<StartMarketingDate>19590528</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA011757</ApplicationNumber>
<LabelerName>Pharmacia and Upjohn Company LLC</LabelerName>
<SubstanceName>METHYLPREDNISOLONE ACETATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-12-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19590528</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0009-0280-52</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 PACKAGE (0009-0280-52) / 10 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>00009-0280-52</NDC11Code>
<ProductNDC>0009-0280</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Depo-medrol</ProprietaryName>
<NonProprietaryName>Methylprednisolone Acetate</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE</RouteName>
<StartMarketingDate>19590528</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA011757</ApplicationNumber>
<LabelerName>Pharmacia & Upjohn Company LLC</LabelerName>
<SubstanceName>METHYLPREDNISOLONE ACETATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19590528</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intramuscular use of DEPO-MEDROL Sterile Aqueous Suspension is indicated as follows. Allergic States: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic Diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal Diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic Disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), pure red cell aplasia, select cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic Diseases: For palliative management of leukemias and lymphomas. Nervous System: Cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic Diseases: Sympathetic ophthalmia, temporal arteritis, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal Diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus. Respiratory Diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic Disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
<Description>DEPO-MEDROL is an anti-inflammatory glucocorticoid for intramuscular, intra-articular, soft tissue, or intralesional injection. It is available in three strengths: 20 mg/mL, 40 mg/mL, 80 mg/mL. Each mL of these preparations contains. Sodium Chloride was added to adjust tonicity. When necessary, pH was adjusted with sodium hydroxide and/or hydrochloric acid. The pH of the finished product remains within the USP specified range (e.g., 3.5 to 7.0). The chemical name for methylprednisolone acetate is pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-11,17-dihydroxy-6-methyl-,(6α,11ß)- and the molecular weight is 416.51. The structural formula is represented below. DEPO-MEDROL Sterile Aqueous Suspension contains methylprednisolone acetate which is the 6-methyl derivative of prednisolone. Methylprednisolone acetate is a white or practically white, odorless, crystalline powder which melts at about 215° with some decomposition. It is soluble in dioxane, sparingly soluble in acetone, alcohol, chloroform, and methanol, and slightly soluble in ether. It is practically insoluble in water.</Description>
</NDC>
<NDC>
<NDCCode>0268-0280-10</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (0268-0280-10) </PackageDescription>
<NDC11Code>00268-0280-10</NDC11Code>
<ProductNDC>0268-0280</ProductNDC>
<ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Timothy, Standardized</ProprietaryName>
<NonProprietaryName>Timothy, Standardized</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>19971218</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103058</ApplicationNumber>
<LabelerName>ALK-Abello, Inc.</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>Deprecated</Status>
<LastUpdate>2023-05-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19971218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0280-0001-04</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 CARTON (0280-0001-04) / 10 GUM, CHEWING in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00280-0001-04</NDC11Code>
<ProductNDC>0280-0001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alka-seltzer Cool Action Heartburn Relief</ProprietaryName>
<ProprietaryNameSuffix>Mint</ProprietaryNameSuffix>
<NonProprietaryName>Calcium Carbonate</NonProprietaryName>
<DosageFormName>GUM, CHEWING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M001</ApplicationNumber>
<LabelerName>Bayer HealthCare LLC.</LabelerName>
<SubstanceName>CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses for the relief of:. ● acid indigestion ● heartburn ● sour stomach. ● upset stomach associated with these symptoms.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0280-0020-01</NDCCode>
<PackageDescription>10 POUCH in 1 CARTON (0280-0020-01) / 2 TABLET, EFFERVESCENT in 1 POUCH</PackageDescription>
<NDC11Code>00280-0020-01</NDC11Code>
<ProductNDC>0280-0020</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alka-seltzer Plus Severe Cold Powerfast Fizz</ProprietaryName>
<ProprietaryNameSuffix>Orange Zest</ProprietaryNameSuffix>
<NonProprietaryName>Aspirin, Chlorpheniramine Maleate, Phenylephrine Bitartrate</NonProprietaryName>
<DosageFormName>TABLET, EFFERVESCENT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200701</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Bayer HealthCare LLC.</LabelerName>
<SubstanceName>PHENYLEPHRINE BITARTRATE; CHLORPHENIRAMINE MALEATE; ASPIRIN</SubstanceName>
<StrengthNumber>7; 2; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. · temporarily relieves these symptoms due to a cold. · minor aches and pains · headache · runny nose. · nasal and sinus congestion · sneezing · sore throat. · temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0280-0021-01</NDCCode>
<PackageDescription>10 POUCH in 1 CARTON (0280-0021-01) / 2 TABLET, EFFERVESCENT in 1 POUCH</PackageDescription>
<NDC11Code>00280-0021-01</NDC11Code>
<ProductNDC>0280-0021</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alka-seltzer Plus Severe Cold Powerfast Fizz Night</ProprietaryName>
<NonProprietaryName>Aspirin, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Bitartrate</NonProprietaryName>
<DosageFormName>TABLET, EFFERVESCENT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Bayer HealthCare LLC.</LabelerName>
<SubstanceName>ASPIRIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE BITARTRATE; DOXYLAMINE SUCCINATE</SubstanceName>
<StrengthNumber>500; 10; 7.8; 6.25</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Antihistamine [EPC], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Histamine Receptor Antagonists [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. ● temporarily relieves these symptoms due to a cold. ● minor aches and pains ● headache ● runny nose. ● sinus congestion and pressure ● cough ● sneezing. ● sore throat ● nasal congestion. ● temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0280-0022-01</NDCCode>
<PackageDescription>10 POUCH in 1 CARTON (0280-0022-01) / 2 TABLET, EFFERVESCENT in 1 POUCH</PackageDescription>
<NDC11Code>00280-0022-01</NDC11Code>
<ProductNDC>0280-0022</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alka-seltzer Plus Severe Cold And Flu Powerfast Fizz</ProprietaryName>
<NonProprietaryName>Chlorpheniramine Maleate, Acetaminophen, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide</NonProprietaryName>
<DosageFormName>TABLET, EFFERVESCENT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Bayer HealthCare LLC.</LabelerName>
<SubstanceName>ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>250; 2; 10; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. · temporarily relieves these symptoms due to a cold or flu. · minor aches and pains · headache · cough. · sore throat · runny nose · sneezing. · nasal and sinus congestion. · temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0280-0023-01</NDCCode>
<PackageDescription>10 POUCH in 1 CARTON (0280-0023-01) / 2 TABLET, EFFERVESCENT in 1 POUCH</PackageDescription>
<NDC11Code>00280-0023-01</NDC11Code>
<ProductNDC>0280-0023</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alka-seltzer Plus Severe Cold And Cough Powerfast Fizz</ProprietaryName>
<NonProprietaryName>Aspirin, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Bitartrate</NonProprietaryName>
<DosageFormName>TABLET, EFFERVESCENT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Bayer Healthcare LLC.</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE</SubstanceName>
<StrengthNumber>10; 325; 2; 7.8</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. · temporarily relieves these symptoms due to a cold with cough. · minor aches and pains · headache · cough. · runny nose · nasal and sinus congestion. · sneezing · sore throat. · temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0280-0024-01</NDCCode>
<PackageDescription>10 POUCH in 1 CARTON (0280-0024-01) / 2 TABLET, EFFERVESCENT in 1 POUCH</PackageDescription>
<NDC11Code>00280-0024-01</NDC11Code>
<ProductNDC>0280-0024</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alka-seltzer Plus Severe Cold Powerfast Fizz Non Drowsy</ProprietaryName>
<NonProprietaryName>Asprin, Dextromethorphan Hydrobromide, Phenylephrine Bitartrate</NonProprietaryName>
<DosageFormName>TABLET, EFFERVESCENT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Bayer HealthCare LLC.</LabelerName>
<SubstanceName>ASPIRIN; PHENYLEPHRINE BITARTRATE; DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
<StrengthNumber>325; 7.8; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>