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"StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL",
"Pharm_Classes": "Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Vaccines, Conjugate [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS]",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210810",
"SamplePackage": "N",
"IndicationAndUsage": "Prevnar 20® is a vaccine indicated for : 1 active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in individuals 6 weeks of age and older., 2 active immunization for the prevention of otitis media caused by S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F in individuals 6 weeks through 5 years of age., 3 active immunization for the prevention of pneumonia caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in individuals 18 years of age and older.",
"Description": "Prevnar 20, Pneumococcal 20-valent Conjugate Vaccine is a sterile suspension of saccharides of the capsular antigens of S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F, individually linked to non-toxic diphtheria CRM197 protein. Each serotype is grown in soy peptone broth. The individual polysaccharides are purified by a series of chemical and physical methods. The polysaccharides are chemically activated and then directly conjugated to the carrier protein CRM197, to form the glycoconjugate. CRM197 is a non-toxic variant of diphtheria toxin isolated from cultures of Corynebacterium diphtheriae strain C7 (β197) grown in a casamino acids and yeast extract-based medium or in a chemically-defined medium. CRM197 is purified by a series of chemical and physical methods. The individual glycoconjugates are purified by a series of chemical and physical methods and analyzed for saccharide to protein ratios, molecular size, free saccharide, and free protein. The individual glycoconjugates are compounded to formulate Prevnar 20. Potency of the formulated vaccine is determined by quantification of each of the saccharide antigens and by the saccharide to protein ratios in the individual glycoconjugates. Each 0.5 mL dose of the vaccine is formulated to contain approximately 2.2 μg of each of S. pneumoniae serotypes 1, 3, 4, 5, 6A, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 33F saccharides, 4.4 μg of 6B saccharides, 51 μg CRM197 carrier protein, 100 μg polysorbate 80, 295 μg succinate buffer, 4.4 mg sodium chloride, and 125 μg aluminum as aluminum phosphate adjuvant."
},
{
"NDCCode": "0268-2000-10",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (0268-2000-10) ",
"NDC11Code": "00268-2000-10",
"ProductNDC": "0268-2000",
"ProductTypeName": "STANDARDIZED ALLERGENIC",
"ProprietaryName": "Cat Hair, Standardized",
"NonProprietaryName": "Cat Hair, Standardized",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20031128",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103810",
"LabelerName": "ALK-Abello, Inc.",
"SubstanceName": "FELIS CATUS HAIR",
"StrengthNumber": "10000",
"StrengthUnit": "[BAU]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dander [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Salivary Proteins and Peptides [CS], Standardized Animal Hair Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2020-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20031128",
"SamplePackage": "N",
"IndicationAndUsage": "Standardized Cat Hair allergenic extracts are indicated for the diagnostic skin testing and immunotherapy of patients whose histories indicate that they experience allergic symptoms upon natural exposure to the specific allergens.",
"Description": "Standardized cat hair extract is manufactured from source material obtained from the wash of cat hair clippings, which is then concentrated and absorbed onto powdered cat hair. Cat albumin and other serum-related non-Fel d 1 allergens, found in cat pelt extracts, have not been included in this extract. Cat albumin is not an important allergen for 80% of cat-sensitive patients2. They are supplied as sterile solutions for scratch, intradermal or subcutaneous administration. The inactive ingredients are as shown in Table 1. Standardized cat hair extracts containing 10 to19.9 Fel d 1 units per ml are assigned 10,000 Bioequivalent Allergy Units per ml (BAU/mI) based on quantitative skin testing3. Standardized cat hair extracts containing 5 to 9.9 Fel d 1 units per ml are assigned 5,000 BAU/ml. Isoelectric focusing (IEF) patterns of these standardized cat extracts have been shown to be predictive of the presence of non-Fel d 1 allergens. IEF has been adopted by the FDA as a release criterion. Therefore, all lots of Standardized Cat Hair extract are required to be compared by IEF to Center for Biologics Evaluation and Research (CBER) Cat Hair Extract Reference4. Allergenic extracts must be diluted before use in intradermal diagnosis or in the initial stages of treatment."
},
{
"NDCCode": "0280-2000-10",
"PackageDescription": "1 BOTTLE in 1 CARTON (0280-2000-10) / 100 TABLET in 1 BOTTLE",
"NDC11Code": "00280-2000-10",
"ProductNDC": "0280-2000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bayer Genuine Aspirin",
"NonProprietaryName": "Aspirin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140731",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Bayer HealthCare LLC.",
"SubstanceName": "ASPIRIN",
"StrengthNumber": "325",
"StrengthUnit": "mg/1",
"Pharm_Classes": "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]",
"Status": "Active",
"LastUpdate": "2025-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140731",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves: 1 headache, 2 muscle pain, 3 toothache, 4 menstrual pain, 5 pain and fever of colds, 6 minor pain of arthritis."
},
{
"NDCCode": "0498-2000-10",
"PackageDescription": "100 PACKET in 1 BOX, UNIT-DOSE (0498-2000-10) > 2 TABLET in 1 PACKET",
"NDC11Code": "00498-2000-10",
"ProductNDC": "0498-2000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aypanal",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120410",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "North Safety Products",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "325",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-12-13",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "36987-2000-2",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (36987-2000-2)",
"NDC11Code": "36987-2000-02",
"ProductNDC": "36987-2000",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bipolaris Sorokiniana",
"NonProprietaryName": "Bipolaris Sorokiniana",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "COCHLIOBOLUS SATIVUS",
"StrengthNumber": ".1",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "39822-2000-1",
"PackageDescription": "10 mL in 1 VIAL, SINGLE-DOSE (39822-2000-1) ",
"NDC11Code": "39822-2000-01",
"ProductNDC": "39822-2000",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clonidine",
"NonProprietaryName": "Clonidine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "EPIDURAL",
"StartMarketingDate": "20131029",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203167",
"LabelerName": "XGen Pharmaceuticals DJB, Inc.",
"SubstanceName": "CLONIDINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20131029",
"SamplePackage": "N",
"IndicationAndUsage": "Clonidine hydrochloride injection is indicated in combination with opiates for the treatment of severe pain in cancer patients that is not adequately relieved by opioid analgesics alone. Epidural clonidine is more likely to be effective in patients with neuropathic pain than somatic or visceral pain (see Clinical Trials). The safety of this drug product has only been established in a highly selected group of cancer patients, and only after an adequate trial of opioid analgesia. Other use is of unproven safety and is not recommended. In a rare patient, the potential benefits may outweigh the known risks (see WARNINGS).",
"Description": "Clonidine hydrochloride injection is a centrally-acting analgesic solution for use in continuous epidural infusion devices. Clonidine Hydrochloride, USP, is an imidazoline derivative and exists as a mesomeric compound. The chemical names are Benzenamine, 2,6-dichloro-N-2-imidazolidinylidene monohydrochloride and 2-[(2,6-dichlorophenyl)imino]imidazolidine monohydrochloride. The following is the structural formula. Clonidine hydrochloride injection is supplied as a clear, colorless, preservative-free, pyrogen-free, aqueous sterile solution (pH 5 to 7) in single-dose, 10 mL vials. Each mL of the 100 mcg/mL (0.1 mg/mL) concentration contains 100 mcg of Clonidine Hydrochloride, USP and 9 mg Sodium Chloride in Water for Injection, USP. Hydrochloric Acid and/or Sodium Hydroxide may have been added for pH adjustment. Each 10 mL vial contains 1 mg (1000 mcg) of clonidine hydrochloride. Each mL of the 500 mcg/mL (0.5 mg/mL) concentration contains 500 mcg of Clonidine Hydrochloride, USP and 9 mg Sodium Chloride in Water for Injection, USP. Hydrochloric Acid and/or Sodium Hydroxide may have been added for pH adjustment. Each 10 mL vial contains 5 mg (5000 mcg) of clonidine hydrochloride."
},
{
"NDCCode": "41699-2000-2",
"PackageDescription": "10 kg in 1 CONTAINER (41699-2000-2) ",
"NDC11Code": "41699-2000-02",
"ProductNDC": "41699-2000",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Bacitracin",
"DosageFormName": "POWDER",
"StartMarketingDate": "20241216",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Lifecome Biochemistry Co., Ltd",
"SubstanceName": "BACITRACIN",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2026-02-10",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "16-DEC-24"
},
{
"NDCCode": "44738-6001-2",
"PackageDescription": "10 POUCH in 1 CARTON (44738-6001-2) > 2000 mg in 1 POUCH (44738-6001-1)",
"NDC11Code": "44738-6001-02",
"ProductNDC": "44738-6001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ginsamin Beauty",
"NonProprietaryName": "Ginkgo Leaf Extract",
"DosageFormName": "GRANULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100307",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Biogrand Co., Ltd",
"SubstanceName": "GINKGO; ASIAN GINSENG; N-ACETYLGLUCOSAMINE; HYALURONIC ACID",
"StrengthNumber": "150; 150; 200; 60",
"StrengthUnit": "mg/2000mg; mg/2000mg; mg/2000mg; mg/2000mg",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "49701-2000-1",
"PackageDescription": "10 mL in 1 BOTTLE, SPRAY (49701-2000-1)",
"NDC11Code": "49701-2000-01",
"ProductNDC": "49701-2000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antibacterial Hand Sanitizer Spray",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20091201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333",
"LabelerName": "The Webb Company",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"Description": "(0.34 oz) Made in China."
},
{
"NDCCode": "58228-8691-1",
"PackageDescription": "2000 BAG in 1 CASE (58228-8691-1) / 10 PACKET in 1 BAG / 1.01 mL in 1 PACKET",
"NDC11Code": "58228-8691-01",
"ProductNDC": "58228-8691",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Hand Sanitizer",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240108",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "ProStat First Aid LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2025-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240108",
"SamplePackage": "N",
"IndicationAndUsage": "For handwashing to decrease bacteria on the skin."
},
{
"NDCCode": "59149-004-10",
"PackageDescription": "2000 g in 1 BOTTLE, GLASS (59149-004-10) ",
"NDC11Code": "59149-0004-10",
"ProductNDC": "59149-004",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Exenatide",
"DosageFormName": "POWDER",
"StartMarketingDate": "20230220",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "PolyPeptide Laboratories Private Limited",
"SubstanceName": "EXENATIDE",
"StrengthNumber": "250",
"StrengthUnit": "g/250g",
"Status": "Unfinished",
"LastUpdate": "2023-02-28",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20-FEB-23"
},
{
"NDCCode": "61788-2000-1",
"PackageDescription": "10 kg in 1 DRUM (61788-2000-1)",
"NDC11Code": "61788-2000-01",
"ProductNDC": "61788-2000",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Cefdinir",
"DosageFormName": "POWDER",
"StartMarketingDate": "20150428",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Covalent Laboratories Private Limited",
"SubstanceName": "CEFDINIR",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2019-10-23",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "67684-2000-0",
"PackageDescription": "10 VIAL in 1 PACKAGE (67684-2000-0) / 5 mL in 1 VIAL",
"NDC11Code": "67684-2000-00",
"ProductNDC": "67684-2000",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dotarem",
"NonProprietaryName": "Gadoterate Meglumine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20130320",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204781",
"LabelerName": "Guerbet LLC",
"SubstanceName": "GADOTERATE MEGLUMINE",
"StrengthNumber": "376.9",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Gadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170331",
"SamplePackage": "N",
"IndicationAndUsage": "DOTAREM is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.",
"Description": "DOTAREM (gadoterate meglumine) is a paramagnetic macrocyclic ionic contrast agent administered for magnetic resonance imaging. The chemical name for gadoterate meglumine is D-glucitol, 1-deoxy-1-(methylamino)-,[1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraaceto(4-)-.kappa.N1, .kappa.N4, .kappa.N7, .kappa.N10, .kappa.O1, .kappa.O4, .kappa.O7, .kappa.O10]gadolinate(1-)(1:1); it has a formula weight of 753.9 g/mol and empirical formula of C 23H 42O 13N 5Gd (anhydrous basis). The structural formula of gadoterate meglumine in solution is as follows. CAS Registry No. 92943-93-6. DOTAREM Injection is a sterile, nonpyrogenic, clear, colorless to yellow, aqueous solution of 0.5 mmol/mL of gadoterate meglumine. No preservative is added. Each mL of DOTAREM contains 376.9 mg of gadoterate meglumine, 0.25 mg of DOTA and water for injection. DOTAREM has a pH of 6.5 to 8.0. The main physiochemical properties of DOTAREM are provided below. The thermodynamic stability constants for gadoterate (log K therm and log K cond at pH 7.4) are 25.6 and 19.3, respectively."
},
{
"NDCCode": "67684-2000-1",
"PackageDescription": "10 VIAL in 1 PACKAGE (67684-2000-1) / 10 mL in 1 VIAL",
"NDC11Code": "67684-2000-01",
"ProductNDC": "67684-2000",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dotarem",
"NonProprietaryName": "Gadoterate Meglumine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20130320",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204781",
"LabelerName": "Guerbet LLC",
"SubstanceName": "GADOTERATE MEGLUMINE",
"StrengthNumber": "376.9",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Gadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-03-24",
"PackageNdcExcludeFlag": "N",
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"Description": "DOTAREM (gadoterate meglumine) is a paramagnetic macrocyclic ionic contrast agent administered for magnetic resonance imaging. The chemical name for gadoterate meglumine is D-glucitol, 1-deoxy-1-(methylamino)-,[1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraaceto(4-)-.kappa.N1, .kappa.N4, .kappa.N7, .kappa.N10, .kappa.O1, .kappa.O4, .kappa.O7, .kappa.O10]gadolinate(1-)(1:1); it has a formula weight of 753.9 g/mol and empirical formula of C 23H 42O 13N 5Gd (anhydrous basis). The structural formula of gadoterate meglumine in solution is as follows. CAS Registry No. 92943-93-6. DOTAREM Injection is a sterile, nonpyrogenic, clear, colorless to yellow, aqueous solution of 0.5 mmol/mL of gadoterate meglumine. No preservative is added. Each mL of DOTAREM contains 376.9 mg of gadoterate meglumine, 0.25 mg of DOTA and water for injection. DOTAREM has a pH of 6.5 to 8.0. The main physiochemical properties of DOTAREM are provided below. The thermodynamic stability constants for gadoterate (log K therm and log K cond at pH 7.4) are 25.6 and 19.3, respectively."
}
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<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>Active</Status>
<LastUpdate>2024-04-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060927</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to:oheadache oa coldoarthritisomuscular achesotoothache opremenstrual & menstrual cramps.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0067-2000-91</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0067-2000-91) / 100 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>00067-2000-91</NDC11Code>
<ProductNDC>0067-2000</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Excedrin</ProprietaryName>
<ProprietaryNameSuffix>Extra Strength Pain Reliever</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Aspirin (nsaid), And Caffeine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060927</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Haleon US Holdings LLC</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>Active</Status>
<LastUpdate>2024-04-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060927</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to:oheadache oa coldoarthritisomuscular achesotoothache opremenstrual & menstrual cramps.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0067-2000-94</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (0067-2000-94)</PackageDescription>
<NDC11Code>00067-2000-94</NDC11Code>
<ProductNDC>0067-2000</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Excedrin</ProprietaryName>
<ProprietaryNameSuffix>Extra Strength Pain Reliever</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Aspirin (nsaid), And Caffeine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060927</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>GlaxoSmithKline Consumer Healthcare Holdings (US) LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; ASPIRIN; CAFFEINE</SubstanceName>
<StrengthNumber>250; 250; 65</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-03-15</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0067-8148-01</NDCCode>
<PackageDescription>1 KIT in 1 PACKAGE, COMBINATION (0067-8148-01) * 1 BOTTLE in 1 CARTON (0067-2056-24) / 24 TABLET, COATED in 1 BOTTLE * 1 BOTTLE in 1 CARTON (0067-2000-91) / 100 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>00067-8148-01</NDC11Code>
<ProductNDC>0067-8148</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Excedrin Pm Triple Action Caplets And Excedrin Extra Strength Pain Reliever</ProprietaryName>
<NonProprietaryName>Acetaminophen, Aspirin (nsaid), Caffeine, And Diphenhydramine Citrate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20180501</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Haleon US Holdings LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0067-8151-01</NDCCode>
<PackageDescription>1 KIT in 1 PACKAGE, COMBINATION (0067-8151-01) * 1 BOTTLE in 1 CARTON (0067-8139-01) / 24 TABLET, FILM COATED in 1 BOTTLE * 1 BOTTLE in 1 CARTON (0067-2000-91) / 100 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>00067-8151-01</NDC11Code>
<ProductNDC>0067-8151</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Excedrin Extra Strength And Excedrin Tension Headache</ProprietaryName>
<NonProprietaryName>Acetaminophen, Aspirin (nsaid), And Caffeine</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20180930</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Haleon US Holdings LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0005-2000-10</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (0005-2000-10) / .5 mL in 1 SYRINGE (0005-2000-01) </PackageDescription>
<NDC11Code>00005-2000-10</NDC11Code>
<ProductNDC>0005-2000</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Prevnar 20</ProprietaryName>
<NonProprietaryName>Pneumococcal 20-valent Conjugate Vaccine</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20210810</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125731</ApplicationNumber>
<LabelerName>Wyeth Pharmaceutical Division of Wyeth Holdings LLC</LabelerName>
<SubstanceName>STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 4 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 5 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 6A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 6B CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 7F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 8 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 9V CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 10A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 11A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 12F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 15B CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 22F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 23F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 33F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN</SubstanceName>
<StrengthNumber>2.2; 2.2; 2.2; 2.2; 2.2; 4.4; 2.2; 2.2; 2.2; 2.2; 2.2; 2.2; 2.2; 2.2; 2.2; 2.2; 2.2; 2.2; 2.2; 2.2</StrengthNumber>
<StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
<Pharm_Classes>Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Vaccines, Conjugate [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210810</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Prevnar 20® is a vaccine indicated for : 1 active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in individuals 6 weeks of age and older., 2 active immunization for the prevention of otitis media caused by S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F in individuals 6 weeks through 5 years of age., 3 active immunization for the prevention of pneumonia caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in individuals 18 years of age and older.</IndicationAndUsage>
<Description>Prevnar 20, Pneumococcal 20-valent Conjugate Vaccine is a sterile suspension of saccharides of the capsular antigens of S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F, individually linked to non-toxic diphtheria CRM197 protein. Each serotype is grown in soy peptone broth. The individual polysaccharides are purified by a series of chemical and physical methods. The polysaccharides are chemically activated and then directly conjugated to the carrier protein CRM197, to form the glycoconjugate. CRM197 is a non-toxic variant of diphtheria toxin isolated from cultures of Corynebacterium diphtheriae strain C7 (β197) grown in a casamino acids and yeast extract-based medium or in a chemically-defined medium. CRM197 is purified by a series of chemical and physical methods. The individual glycoconjugates are purified by a series of chemical and physical methods and analyzed for saccharide to protein ratios, molecular size, free saccharide, and free protein. The individual glycoconjugates are compounded to formulate Prevnar 20. Potency of the formulated vaccine is determined by quantification of each of the saccharide antigens and by the saccharide to protein ratios in the individual glycoconjugates. Each 0.5 mL dose of the vaccine is formulated to contain approximately 2.2 μg of each of S. pneumoniae serotypes 1, 3, 4, 5, 6A, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 33F saccharides, 4.4 μg of 6B saccharides, 51 μg CRM197 carrier protein, 100 μg polysorbate 80, 295 μg succinate buffer, 4.4 mg sodium chloride, and 125 μg aluminum as aluminum phosphate adjuvant.</Description>
</NDC>
<NDC>
<NDCCode>0268-2000-10</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (0268-2000-10) </PackageDescription>
<NDC11Code>00268-2000-10</NDC11Code>
<ProductNDC>0268-2000</ProductNDC>
<ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Cat Hair, Standardized</ProprietaryName>
<NonProprietaryName>Cat Hair, Standardized</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20031128</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103810</ApplicationNumber>
<LabelerName>ALK-Abello, Inc.</LabelerName>
<SubstanceName>FELIS CATUS HAIR</SubstanceName>
<StrengthNumber>10000</StrengthNumber>
<StrengthUnit>[BAU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dander [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Salivary Proteins and Peptides [CS], Standardized Animal Hair Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20031128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Standardized Cat Hair allergenic extracts are indicated for the diagnostic skin testing and immunotherapy of patients whose histories indicate that they experience allergic symptoms upon natural exposure to the specific allergens.</IndicationAndUsage>
<Description>Standardized cat hair extract is manufactured from source material obtained from the wash of cat hair clippings, which is then concentrated and absorbed onto powdered cat hair. Cat albumin and other serum-related non-Fel d 1 allergens, found in cat pelt extracts, have not been included in this extract. Cat albumin is not an important allergen for 80% of cat-sensitive patients2. They are supplied as sterile solutions for scratch, intradermal or subcutaneous administration. The inactive ingredients are as shown in Table 1. Standardized cat hair extracts containing 10 to19.9 Fel d 1 units per ml are assigned 10,000 Bioequivalent Allergy Units per ml (BAU/mI) based on quantitative skin testing3. Standardized cat hair extracts containing 5 to 9.9 Fel d 1 units per ml are assigned 5,000 BAU/ml. Isoelectric focusing (IEF) patterns of these standardized cat extracts have been shown to be predictive of the presence of non-Fel d 1 allergens. IEF has been adopted by the FDA as a release criterion. Therefore, all lots of Standardized Cat Hair extract are required to be compared by IEF to Center for Biologics Evaluation and Research (CBER) Cat Hair Extract Reference4. Allergenic extracts must be diluted before use in intradermal diagnosis or in the initial stages of treatment.</Description>
</NDC>
<NDC>
<NDCCode>0280-2000-10</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0280-2000-10) / 100 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>00280-2000-10</NDC11Code>
<ProductNDC>0280-2000</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bayer Genuine Aspirin</ProprietaryName>
<NonProprietaryName>Aspirin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140731</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Bayer HealthCare LLC.</LabelerName>
<SubstanceName>ASPIRIN</SubstanceName>
<StrengthNumber>325</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>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]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140731</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves: 1 headache, 2 muscle pain, 3 toothache, 4 menstrual pain, 5 pain and fever of colds, 6 minor pain of arthritis.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0498-2000-10</NDCCode>
<PackageDescription>100 PACKET in 1 BOX, UNIT-DOSE (0498-2000-10) > 2 TABLET in 1 PACKET</PackageDescription>
<NDC11Code>00498-2000-10</NDC11Code>
<ProductNDC>0498-2000</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aypanal</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120410</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>North Safety Products</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>325</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-13</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>36987-2000-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (36987-2000-2)</PackageDescription>
<NDC11Code>36987-2000-02</NDC11Code>
<ProductNDC>36987-2000</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bipolaris Sorokiniana</ProprietaryName>
<NonProprietaryName>Bipolaris Sorokiniana</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>COCHLIOBOLUS SATIVUS</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>39822-2000-1</NDCCode>
<PackageDescription>10 mL in 1 VIAL, SINGLE-DOSE (39822-2000-1) </PackageDescription>
<NDC11Code>39822-2000-01</NDC11Code>
<ProductNDC>39822-2000</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clonidine</ProprietaryName>
<NonProprietaryName>Clonidine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>EPIDURAL</RouteName>
<StartMarketingDate>20131029</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203167</ApplicationNumber>
<LabelerName>XGen Pharmaceuticals DJB, Inc.</LabelerName>
<SubstanceName>CLONIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131029</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clonidine hydrochloride injection is indicated in combination with opiates for the treatment of severe pain in cancer patients that is not adequately relieved by opioid analgesics alone. Epidural clonidine is more likely to be effective in patients with neuropathic pain than somatic or visceral pain (see Clinical Trials). The safety of this drug product has only been established in a highly selected group of cancer patients, and only after an adequate trial of opioid analgesia. Other use is of unproven safety and is not recommended. In a rare patient, the potential benefits may outweigh the known risks (see WARNINGS).</IndicationAndUsage>
<Description>Clonidine hydrochloride injection is a centrally-acting analgesic solution for use in continuous epidural infusion devices. Clonidine Hydrochloride, USP, is an imidazoline derivative and exists as a mesomeric compound. The chemical names are Benzenamine, 2,6-dichloro-N-2-imidazolidinylidene monohydrochloride and 2-[(2,6-dichlorophenyl)imino]imidazolidine monohydrochloride. The following is the structural formula. Clonidine hydrochloride injection is supplied as a clear, colorless, preservative-free, pyrogen-free, aqueous sterile solution (pH 5 to 7) in single-dose, 10 mL vials. Each mL of the 100 mcg/mL (0.1 mg/mL) concentration contains 100 mcg of Clonidine Hydrochloride, USP and 9 mg Sodium Chloride in Water for Injection, USP. Hydrochloric Acid and/or Sodium Hydroxide may have been added for pH adjustment. Each 10 mL vial contains 1 mg (1000 mcg) of clonidine hydrochloride. Each mL of the 500 mcg/mL (0.5 mg/mL) concentration contains 500 mcg of Clonidine Hydrochloride, USP and 9 mg Sodium Chloride in Water for Injection, USP. Hydrochloric Acid and/or Sodium Hydroxide may have been added for pH adjustment. Each 10 mL vial contains 5 mg (5000 mcg) of clonidine hydrochloride.</Description>
</NDC>
<NDC>
<NDCCode>41699-2000-2</NDCCode>
<PackageDescription>10 kg in 1 CONTAINER (41699-2000-2) </PackageDescription>
<NDC11Code>41699-2000-02</NDC11Code>
<ProductNDC>41699-2000</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Bacitracin</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20241216</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Lifecome Biochemistry Co., Ltd</LabelerName>
<SubstanceName>BACITRACIN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-02-10</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>16-DEC-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>44738-6001-2</NDCCode>
<PackageDescription>10 POUCH in 1 CARTON (44738-6001-2) > 2000 mg in 1 POUCH (44738-6001-1)</PackageDescription>
<NDC11Code>44738-6001-02</NDC11Code>
<ProductNDC>44738-6001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ginsamin Beauty</ProprietaryName>
<NonProprietaryName>Ginkgo Leaf Extract</NonProprietaryName>
<DosageFormName>GRANULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100307</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Biogrand Co., Ltd</LabelerName>
<SubstanceName>GINKGO; ASIAN GINSENG; N-ACETYLGLUCOSAMINE; HYALURONIC ACID</SubstanceName>
<StrengthNumber>150; 150; 200; 60</StrengthNumber>
<StrengthUnit>mg/2000mg; mg/2000mg; mg/2000mg; mg/2000mg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>49701-2000-1</NDCCode>
<PackageDescription>10 mL in 1 BOTTLE, SPRAY (49701-2000-1)</PackageDescription>
<NDC11Code>49701-2000-01</NDC11Code>
<ProductNDC>49701-2000</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antibacterial Hand Sanitizer Spray</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20091201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333</ApplicationNumber>
<LabelerName>The Webb Company</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<Description>(0.34 oz) Made in China.</Description>
</NDC>
<NDC>
<NDCCode>58228-8691-1</NDCCode>
<PackageDescription>2000 BAG in 1 CASE (58228-8691-1) / 10 PACKET in 1 BAG / 1.01 mL in 1 PACKET</PackageDescription>
<NDC11Code>58228-8691-01</NDC11Code>
<ProductNDC>58228-8691</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Hand Sanitizer</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240108</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>ProStat First Aid LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240108</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For handwashing to decrease bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59149-004-10</NDCCode>
<PackageDescription>2000 g in 1 BOTTLE, GLASS (59149-004-10) </PackageDescription>
<NDC11Code>59149-0004-10</NDC11Code>
<ProductNDC>59149-004</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Exenatide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20230220</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>PolyPeptide Laboratories Private Limited</LabelerName>
<SubstanceName>EXENATIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>g/250g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2023-02-28</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20-FEB-23</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>61788-2000-1</NDCCode>
<PackageDescription>10 kg in 1 DRUM (61788-2000-1)</PackageDescription>
<NDC11Code>61788-2000-01</NDC11Code>
<ProductNDC>61788-2000</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Cefdinir</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20150428</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Covalent Laboratories Private Limited</LabelerName>
<SubstanceName>CEFDINIR</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2019-10-23</LastUpdate>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>67684-2000-0</NDCCode>
<PackageDescription>10 VIAL in 1 PACKAGE (67684-2000-0) / 5 mL in 1 VIAL</PackageDescription>
<NDC11Code>67684-2000-00</NDC11Code>
<ProductNDC>67684-2000</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dotarem</ProprietaryName>
<NonProprietaryName>Gadoterate Meglumine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20130320</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204781</ApplicationNumber>
<LabelerName>Guerbet LLC</LabelerName>
<SubstanceName>GADOTERATE MEGLUMINE</SubstanceName>
<StrengthNumber>376.9</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Gadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170331</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DOTAREM is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.</IndicationAndUsage>
<Description>DOTAREM (gadoterate meglumine) is a paramagnetic macrocyclic ionic contrast agent administered for magnetic resonance imaging. The chemical name for gadoterate meglumine is D-glucitol, 1-deoxy-1-(methylamino)-,[1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraaceto(4-)-.kappa.N1, .kappa.N4, .kappa.N7, .kappa.N10, .kappa.O1, .kappa.O4, .kappa.O7, .kappa.O10]gadolinate(1-)(1:1); it has a formula weight of 753.9 g/mol and empirical formula of C 23H 42O 13N 5Gd (anhydrous basis). The structural formula of gadoterate meglumine in solution is as follows. CAS Registry No. 92943-93-6. DOTAREM Injection is a sterile, nonpyrogenic, clear, colorless to yellow, aqueous solution of 0.5 mmol/mL of gadoterate meglumine. No preservative is added. Each mL of DOTAREM contains 376.9 mg of gadoterate meglumine, 0.25 mg of DOTA and water for injection. DOTAREM has a pH of 6.5 to 8.0. The main physiochemical properties of DOTAREM are provided below. The thermodynamic stability constants for gadoterate (log K therm and log K cond at pH 7.4) are 25.6 and 19.3, respectively.</Description>
</NDC>
<NDC>
<NDCCode>67684-2000-1</NDCCode>
<PackageDescription>10 VIAL in 1 PACKAGE (67684-2000-1) / 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>67684-2000-01</NDC11Code>
<ProductNDC>67684-2000</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dotarem</ProprietaryName>
<NonProprietaryName>Gadoterate Meglumine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20130320</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204781</ApplicationNumber>
<LabelerName>Guerbet LLC</LabelerName>
<SubstanceName>GADOTERATE MEGLUMINE</SubstanceName>
<StrengthNumber>376.9</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Gadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130320</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DOTAREM is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.</IndicationAndUsage>
<Description>DOTAREM (gadoterate meglumine) is a paramagnetic macrocyclic ionic contrast agent administered for magnetic resonance imaging. The chemical name for gadoterate meglumine is D-glucitol, 1-deoxy-1-(methylamino)-,[1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraaceto(4-)-.kappa.N1, .kappa.N4, .kappa.N7, .kappa.N10, .kappa.O1, .kappa.O4, .kappa.O7, .kappa.O10]gadolinate(1-)(1:1); it has a formula weight of 753.9 g/mol and empirical formula of C 23H 42O 13N 5Gd (anhydrous basis). The structural formula of gadoterate meglumine in solution is as follows. CAS Registry No. 92943-93-6. DOTAREM Injection is a sterile, nonpyrogenic, clear, colorless to yellow, aqueous solution of 0.5 mmol/mL of gadoterate meglumine. No preservative is added. Each mL of DOTAREM contains 376.9 mg of gadoterate meglumine, 0.25 mg of DOTA and water for injection. DOTAREM has a pH of 6.5 to 8.0. The main physiochemical properties of DOTAREM are provided below. The thermodynamic stability constants for gadoterate (log K therm and log K cond at pH 7.4) are 25.6 and 19.3, respectively.</Description>
</NDC>
<NDC>
<NDCCode>67684-2000-2</NDCCode>
<PackageDescription>10 VIAL in 1 PACKAGE (67684-2000-2) / 15 mL in 1 VIAL</PackageDescription>
<NDC11Code>67684-2000-02</NDC11Code>
<ProductNDC>67684-2000</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dotarem</ProprietaryName>
<NonProprietaryName>Gadoterate Meglumine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20130320</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204781</ApplicationNumber>
<LabelerName>Guerbet LLC</LabelerName>
<SubstanceName>GADOTERATE MEGLUMINE</SubstanceName>
<StrengthNumber>376.9</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Gadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130320</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DOTAREM is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.</IndicationAndUsage>
<Description>DOTAREM (gadoterate meglumine) is a paramagnetic macrocyclic ionic contrast agent administered for magnetic resonance imaging. The chemical name for gadoterate meglumine is D-glucitol, 1-deoxy-1-(methylamino)-,[1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraaceto(4-)-.kappa.N1, .kappa.N4, .kappa.N7, .kappa.N10, .kappa.O1, .kappa.O4, .kappa.O7, .kappa.O10]gadolinate(1-)(1:1); it has a formula weight of 753.9 g/mol and empirical formula of C 23H 42O 13N 5Gd (anhydrous basis). The structural formula of gadoterate meglumine in solution is as follows. CAS Registry No. 92943-93-6. DOTAREM Injection is a sterile, nonpyrogenic, clear, colorless to yellow, aqueous solution of 0.5 mmol/mL of gadoterate meglumine. No preservative is added. Each mL of DOTAREM contains 376.9 mg of gadoterate meglumine, 0.25 mg of DOTA and water for injection. DOTAREM has a pH of 6.5 to 8.0. The main physiochemical properties of DOTAREM are provided below. The thermodynamic stability constants for gadoterate (log K therm and log K cond at pH 7.4) are 25.6 and 19.3, respectively.</Description>
</NDC>
<NDC>
<NDCCode>67684-2000-3</NDCCode>
<PackageDescription>10 VIAL in 1 PACKAGE (67684-2000-3) / 20 mL in 1 VIAL</PackageDescription>
<NDC11Code>67684-2000-03</NDC11Code>
<ProductNDC>67684-2000</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dotarem</ProprietaryName>
<NonProprietaryName>Gadoterate Meglumine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20130320</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204781</ApplicationNumber>
<LabelerName>Guerbet LLC</LabelerName>
<SubstanceName>GADOTERATE MEGLUMINE</SubstanceName>
<StrengthNumber>376.9</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Gadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130320</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DOTAREM is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.</IndicationAndUsage>
<Description>DOTAREM (gadoterate meglumine) is a paramagnetic macrocyclic ionic contrast agent administered for magnetic resonance imaging. The chemical name for gadoterate meglumine is D-glucitol, 1-deoxy-1-(methylamino)-,[1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraaceto(4-)-.kappa.N1, .kappa.N4, .kappa.N7, .kappa.N10, .kappa.O1, .kappa.O4, .kappa.O7, .kappa.O10]gadolinate(1-)(1:1); it has a formula weight of 753.9 g/mol and empirical formula of C 23H 42O 13N 5Gd (anhydrous basis). The structural formula of gadoterate meglumine in solution is as follows. CAS Registry No. 92943-93-6. DOTAREM Injection is a sterile, nonpyrogenic, clear, colorless to yellow, aqueous solution of 0.5 mmol/mL of gadoterate meglumine. No preservative is added. Each mL of DOTAREM contains 376.9 mg of gadoterate meglumine, 0.25 mg of DOTA and water for injection. DOTAREM has a pH of 6.5 to 8.0. The main physiochemical properties of DOTAREM are provided below. The thermodynamic stability constants for gadoterate (log K therm and log K cond at pH 7.4) are 25.6 and 19.3, respectively.</Description>
</NDC>
</NDCList>