RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "79903-310-48",
      "PackageDescription": "4 BLISTER PACK in 1 CARTON (79903-310-48)  / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
      "NDC11Code": "79903-0310-48",
      "ProductNDC": "79903-310",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Allergy Relief",
      "NonProprietaryName": "Diphenhydramine Hydrochloride",
      "DosageFormName": "CAPSULE, LIQUID FILLED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20241125",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "Walmart Inc.",
      "SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-06-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250627",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat."
    },
    {
      "NDCCode": "79903-310-24",
      "PackageDescription": "2 BLISTER PACK in 1 CARTON (79903-310-24)  / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
      "NDC11Code": "79903-0310-24",
      "ProductNDC": "79903-310",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Allergy Relief",
      "NonProprietaryName": "Diphenhydramine Hydrochloride",
      "DosageFormName": "CAPSULE, LIQUID FILLED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20241125",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "Walmart Inc.",
      "SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-06-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20241125",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat."
    },
    {
      "NDCCode": "79903-155-48",
      "PackageDescription": "4 BLISTER PACK in 1 CARTON (79903-155-48)  / 12 TABLET, FILM COATED in 1 BLISTER PACK",
      "NDC11Code": "79903-0155-48",
      "ProductNDC": "79903-155",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sinus And Headache",
      "NonProprietaryName": "Acetaminophen, Phenylephrine Hcl",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20050726",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "WALMART INC.",
      "SubstanceName": "ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "325; 5",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-04-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20050726",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:minor aches and painsheadachenasal congestionsinus congestion and pressure. helps decongest sinus openings and passages. promotes sinus drainage. helps clear nasal passages. temporarily reduces fever."
    },
    {
      "NDCCode": "79903-193-48",
      "PackageDescription": "4 BLISTER PACK in 1 CARTON (79903-193-48)  / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
      "NDC11Code": "79903-0193-48",
      "ProductNDC": "79903-193",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Allergy Relief",
      "ProprietaryNameSuffix": "Dye Free",
      "NonProprietaryName": "Diphenhydramine Hcl",
      "DosageFormName": "CAPSULE, LIQUID FILLED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230313",
      "EndMarketingDate": "20280131",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "Wal-Mart Stores Inc",
      "SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-01-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20230313",
      "EndMarketingDatePackage": "20280131",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: sneezing, runny nose, itchy, watery eyes, itching of the nose or throat. temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: sneezing,  runny nose."
    },
    {
      "NDCCode": "79903-206-02",
      "PackageDescription": "1 JAR in 1 CARTON (79903-206-02)  / 48 g in 1 JAR",
      "NDC11Code": "79903-0206-02",
      "ProductNDC": "79903-206",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Advanced Firming And Anti-wrinkle Day Spf 18",
      "ProprietaryNameSuffix": "Eqb",
      "NonProprietaryName": "Avobenzone 2% Octisalate 5% Octocrylene 5%",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240401",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Walmart",
      "SubstanceName": "AVOBENZONE; OCTISALATE",
      "StrengthNumber": "2; 5",
      "StrengthUnit": "g/100g; g/100g",
      "Status": "Active",
      "LastUpdate": "2024-04-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240401",
      "SamplePackage": "N",
      "IndicationAndUsage": "helps prevent sunburn If used as directed with other sun protection measures ( see Oirections),decreases the risk of skin cancer and early skin aging caused by the sun."
    },
    {
      "NDCCode": "79903-316-17",
      "PackageDescription": "48 g in 1 JAR (79903-316-17) ",
      "NDC11Code": "79903-0316-17",
      "ProductNDC": "79903-316",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Equate",
      "NonProprietaryName": "Octocrylene, Homosalate, Octisalate, Avobenzone",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250401",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "WALMART INC",
      "SubstanceName": "OCTOCRYLENE; HOMOSALATE; AVOBENZONE; OCTISALATE",
      "StrengthNumber": "70; 50; 30; 50",
      "StrengthUnit": "mg/g; mg/g; mg/g; mg/g",
      "Status": "Active",
      "LastUpdate": "2026-05-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250401",
      "SamplePackage": "N",
      "IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
    },
    {
      "NDCCode": "0069-1965-02",
      "PackageDescription": "1 VIAL, GLASS in 1 CARTON (0069-1965-02)  / 48 mL in 1 VIAL, GLASS (0069-1965-01) ",
      "NDC11Code": "00069-1965-02",
      "ProductNDC": "0069-1965",
      "ProductTypeName": "PLASMA DERIVATIVE",
      "ProprietaryName": "Cutaquig",
      "NonProprietaryName": "Immunoglobulin G",
      "DosageFormName": "SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20190913",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125668",
      "LabelerName": "Pfizer Laboratories Div Pfizer Inc",
      "SubstanceName": "HUMAN IMMUNOGLOBULIN G",
      "StrengthNumber": "165",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]",
      "Status": "Active",
      "LastUpdate": "2025-10-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190913",
      "SamplePackage": "N",
      "IndicationAndUsage": "CUTAQUIG (Immune Globulin Subcutaneous (Human) - hipp) is a 16.5% immune globulin solution for subcutaneous infusion (IGSC), indicated as replacement therapy for primary humoral immunodeficiency (PI) in adults and pediatric patients 2 years of age and older. This includes, but is not limited to, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.",
      "Description": "CUTAQUIG (Immune Globulin Subcutaneous (Human) - hipp), is a solvent/detergent (S/D)-treated, sterile preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. CUTAQUIG is a solution for injection to be administered subcutaneously. This preparation contains approximately 165 mg of protein per mL (16.5%), of which not less than 96% is normal human immunoglobulin G. CUTAQUIG contains not more than 3% aggregates, not less than 94% monomers and dimers, and not more than 3% fragments. The product contains on average 0.206 mg of IgA /mL. The sodium content of the final solution is not more than 30 mmol/L and the pH is between 5.0 and 5.5. The osmolality is 310 - 380 mOsmol/kg. The manufacturing process for CUTAQUIG isolates IgG without additional chemical or enzymatic modification, and the Fc portion is maintained intact. CUTAQUIG contains the IgG antibody activities present in the donor population. IgG subclasses are fully represented with the following approximate percent of total IgG: IgG1 is 70%, IgG2 is 25%, IgG3 is 3% and IgG4 is 2%. CUTAQUIG contains a broad spectrum of IgG antibodies against bacterial and viral agents that are capable of opsonization and neutralization of microbes and toxins. It contains maltose (79 mg/mL), but no preservatives or sucrose. All units of human plasma used in the manufacture of CUTAQUIG are provided by FDA-approved blood and plasma establishments, and are tested by FDA-licensed serological tests for HBsAg, antibodies to HCV and HIV and Nucleic Acid Test (NAT) for HCV and HIV-1 and found to be non-reactive (negative). The product is manufactured by the cold ethanol fractionation process followed by ultrafiltration and chromatography. The manufacturing process includes treatment with an organic S/D mixture composed of tri-n-butyl phosphate (TNBP) and Octoxynol. The CUTAQUIG manufacturing process shows significant viral reduction in in vitro studies ( Table 6 ). These reductions are achieved through a combination of process steps including cold ethanol fractionation, S/D treatment and pH 4 treatment. Table 6 Pathogen Reduction During CUTAQUIG Manufacturing. * Not calculated for global Log 10 Reduction Factor. HIV-1: Human Immunodeficiency Virus - 1. PRV: Pseudorabies Virus, model virus for e.g. Hepatitis B Virus (HBV). SBV: Sindbis Virus, model virus for Hepatitis C Virus (HCV). MEV: Mouse Encephalomyelitis Virus, model virus for Human Parvovirus B19. PPV: Porcine Parvovirus, model virus for Hepatitis A Virus (HAV). n.a.: not applicable."
    },
    {
      "NDCCode": "0093-3304-16",
      "PackageDescription": "6 POUCH in 1 CARTON (0093-3304-16)  > 1 BLISTER PACK in 1 POUCH (0093-3304-28)  > 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "00093-3304-16",
      "ProductNDC": "0093-3304",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Reclipsen",
      "ProprietaryNameSuffix": "28 Day",
      "NonProprietaryName": "Desogestrel And Ethinyl Estradiol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20170101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075256",
      "LabelerName": "Teva Pharmaceuticals USA, Inc.",
      "Status": "Active",
      "LastUpdate": "2022-02-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20170101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Reclipsen (desogestrel and ethinyl estradiol tablets USP) is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. In a clinical trial with Reclipsen (desogestrel and ethinyl estradiol tablets USP), 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. This rate includes patients who did not take the drug correctly. Table 1: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF TYPICAL USE AND THE FIRST YEAR OF PERFECT USE OF CONTRACEPTION AND THE PERCENTAGE CONTINUING USE AT THE END OF THE FIRST YEAR. UNITED STATES. Reclipsen (desogestrel and ethinyl estradiol tablets USP) has not been studied for and is not indicated for use in emergency contraception.",
      "Description": "Reclipsen (desogestrel and ethinyl estradiol tablets USP) blister cards provide an oral contraceptive regimen of 21 rose-colored, round tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en-20-yn-17-ol) and 0.03 mg ethinyl estradiol, USP (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol). Inactive ingredients include colloidal silicon dioxide, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, hydroxypropyl methylcellulose, lactose monohydrate, polyethylene glycol, polysorbate 80, povidone, pregelatinized corn starch, stearic acid, titanium dioxide, and vitamin E. Reclipsen blister cards also contain 7 white “inactive” tablets for oral administration, containing the following inactive ingredients: lactose anhydrous, magnesium stearate, microcrystalline cellulose and pregelatinized corn starch. Desogestrel. C22H30O M.W. 310.48. Ethinyl Estradiol, USP. C20H24O2 M.W. 296.40. The 21 rose-colored tablets meet USP Dissolution Test 2."
    },
    {
      "NDCCode": "0338-0143-03",
      "PackageDescription": "500 mL in 1 BAG (0338-0143-03) ",
      "NDC11Code": "00338-0143-03",
      "ProductNDC": "0338-0143",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dextrose And Electrolyte No. 48",
      "NonProprietaryName": "Sodium Lactate, Potassium Chloride, Magnesium Chloride, Monobasic Potassium Phosphate, Sodium Chloride And Dextrose Monohydrate",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "19790202",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA017484",
      "LabelerName": "Baxter Healthcare Company",
      "SubstanceName": "DEXTROSE MONOHYDRATE; SODIUM LACTATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE",
      "StrengthNumber": "5; 260; 141; 31; 20; 12",
      "StrengthUnit": "g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
      "Pharm_Classes": "Acidifying Activity [MoA], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-07-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19790202",
      "SamplePackage": "N",
      "IndicationAndUsage": "5% Dextrose and Electrolyte No. 48 Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) is indicated as a source of water, electrolytes, and calories or as an alkalinizing agent.",
      "Description": "5% Dextrose and Electrolyte No. 48 Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in a single dose container for intravenous administration. Each 100 mL contains 5 g Dextrose Hydrous, USP*, 260 mg Sodium Lactate (C3H5NaO3), 141 mg Potassium Chloride, USP (KCl), 31 mg Magnesium Chloride, USP (MgCl26H20), 20 mg Monobasic Potassium Phosphate, NF (KH2PO4), and 12 mg Sodium Chloride, USP (NaCl). It contains no antimicrobial agents. The pH is 5.0 (4.0 to 6.5). 5% Dextrose and Electrolyte No. 48 Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) administered intravenously has value as a source of water, electrolytes, and calories. One liter has an ionic concentration of 25 mEq sodium, 20 mEq potassium, 3 mEq magnesium, 24 mEq chloride, 23 mEq lactate and 3 mEq phosphate (as HPO42-). The osmolarity is 348 mOsmol/L (calc). Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. Administration of substantially hypertonic solutions (≥ 600 mOsmol/L) may cause vein damage. The caloric content is 180 kcal/L. Dextrose is derived from corn. The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies."
    },
    {
      "NDCCode": "0338-1055-48",
      "PackageDescription": "24 BAG in 1 CARTON (0338-1055-48)  / 100 mL in 1 BAG",
      "NDC11Code": "00338-1055-48",
      "ProductNDC": "0338-1055",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metronidazole",
      "NonProprietaryName": "Metronidazole",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "19811224",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018657",
      "LabelerName": "Baxter Healthcare Corporation",
      "SubstanceName": "METRONIDAZOLE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/100mL",
      "Pharm_Classes": "Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]",
      "Status": "Active",
      "LastUpdate": "2026-03-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19811224",
      "SamplePackage": "N",
      "IndicationAndUsage": "Metronidazole Injection is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with Metronidazole Injection therapy. In a mixed aerobic and anaerobic infection, antibacterial drugs appropriate for the treatment of the aerobic infection should be used in addition to Metronidazole Injection. Metronidazole Injection is effective in Bacteroides fragilis infections resistant to clindamycin, chloramphenicol and penicillin. : 1 Intra-Abdominal Infections, including peritonitis, intra-abdominal abscess and liver abscess, caused by Bacteroides species including the B. fragilis group (B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgatus), Clostridium species, Eubacterium species, Peptococcus species and Peptostreptococcus species in adults and pediatric patients less than 4 months of age., 2 Skin and Skin Structure Infections caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species and Fusobacterium species in adults., 3 Gynecologic Infections, including endometritis, endomyometritis, tubo-ovarian abscess and postsurgical vaginal cuff infection, caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species and Fusobacterium species in adults., 4 Bacterial Septicemia caused by Bacteroides species including the B. fragilis group and Clostridium species in adults., 5 Bone and Joint Infections, as adjunctive therapy, caused by Bacteroides species including the B. fragilis group in adults., 6 Central Nervous System (CNS) Infections, including meningitis and brain abscess, caused by Bacteroides species including the B. fragilis group in adults. , 7 Lower Respiratory Tract Infections, including pneumonia, empyema and lung abscess, caused by Bacteroides species including the B. fragilis group in adults., 8 Endocarditis caused by Bacteroides species including the B. fragilis group in adults.",
      "Description": "Metronidazole Injection, USP, is a parenteral formulation of the synthetic nitroimidazole antibacterial agent 2-methyl-5-nitro-1H-imidazole-1-ethanol. Metronidazole Injection, USP, in 100 mL VIAFLEX Plus single dose plastic container, is a sterile, nonpyrogenic, iso-osmotic, buffered solution of 500 mg Metronidazole, USP, 790 mg Sodium Chloride, USP, 47.6 mg Dibasic Sodium Phosphate Dried, USP and 22.9 mg Citric Acid Anhydrous, USP. Metronidazole Injection, USP has an osmolarity of 310 mOsmol/L (calc) and a pH of 5.5 (4.5 to 7.0). Each container contains 14 mEq of sodium. The plastic container is fabricated from a specially formulated polyvinyl chloride plastic. Water can permeate from inside the container into the overwrap in amounts insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies."
    },
    {
      "NDCCode": "0378-7296-53",
      "PackageDescription": "3 POUCH in 1 CARTON (0378-7296-53)  / 1 BLISTER PACK in 1 POUCH (0378-7296-85)  / 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "00378-7296-53",
      "ProductNDC": "0378-7296",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Desogestrel And Ethinyl Estradiol And Ethinyl Estradiol",
      "NonProprietaryName": "Desogestrel And Ethinyl Estradiol And Ethinyl Estradiol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20140716",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202296",
      "LabelerName": "Mylan Pharmaceuticals Inc.",
      "Status": "Active",
      "LastUpdate": "2025-07-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20140716",
      "SamplePackage": "N",
      "IndicationAndUsage": "Desogestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates.",
      "Description": "Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP provide an oral contraceptive regimen of 21 white to off-white round tablets each containing 0.15 mg desogestrel (13-ethyl-11- methylene-18,19-dinor-17 alpha-pregn- 4-en- 20-yn-17-ol), 0.02 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol), and inactive ingredients which include anhydrous lactose, colloidal silicon dioxide, polyvinyl pyrrolidone, potato starch, stearic acid, and vitamin E, followed by 2 inert green round tablets with the following inactive ingredients: FD&C Blue No. 1 Aluminum Lake, ferric oxide yellow, lactose monohydrate, magnesium stearate and polacrilin potassium. Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP, 0.15 mg/0.02 mg and 0.01 mg also contain 5 light peach round tablets containing 0.01 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20- yne-3,17-diol) and inactive ingredients which include anhydrous lactose, dl-alpha-tocopherol, FD&C Yellow No. 6 Aluminum Lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polacrilin potassium and povidone K-25. The molecular weights for desogestrel and ethinyl estradiol are 310.48 and 296.40 respectively. The structural formulas are as follows. Desogestrel and ethinyl estradiol tablets meet USP dissolution test 2."
    },
    {
      "NDCCode": "0409-7929-48",
      "PackageDescription": "12 BAG in 1 CASE (0409-7929-48)  > 1000 mL in 1 BAG",
      "NDC11Code": "00409-7929-48",
      "ProductNDC": "0409-7929",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lactated Ringers And Dextrose",
      "NonProprietaryName": "Sodium Chloride, Sodium Lactate, Potassium Chloride, Calcium Chloride, And Dextrose Monohydrate",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "19750813",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA017608",
      "LabelerName": "Hospira, Inc.",
      "SubstanceName": "CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE",
      "StrengthNumber": "20; 5; 30; 600; 310",
      "StrengthUnit": "mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL",
      "Pharm_Classes": "Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2014-09-05"
    },
    {
      "NDCCode": "0409-7953-48",
      "PackageDescription": "12 BAG in 1 CASE (0409-7953-48)  > 1000 mL in 1 BAG",
      "NDC11Code": "00409-7953-48",
      "ProductNDC": "0409-7953",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lactated Ringers",
      "NonProprietaryName": "Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "19760126",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA017641",
      "LabelerName": "Hospira, Inc.",
      "SubstanceName": "CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE",
      "StrengthNumber": "20; 30; 600; 310",
      "StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL",
      "Pharm_Classes": "Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2014-09-05"
    },
    {
      "NDCCode": "0555-9043-58",
      "PackageDescription": "6 POUCH in 1 CARTON (0555-9043-58)  > 1 BLISTER PACK in 1 POUCH (0555-9043-79)  > 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "00555-9043-58",
      "ProductNDC": "0555-9043",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Apri",
      "ProprietaryNameSuffix": "28 Day",
      "NonProprietaryName": "Desogestrel And Ethinyl Estradiol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "19991022",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075256",
      "LabelerName": "Teva Pharmaceuticals USA, Inc.",
      "Status": "Active",
      "LastUpdate": "2021-12-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19991022",
      "SamplePackage": "N",
      "IndicationAndUsage": "Apri® (desogestrel and ethinyl estradiol tablets USP) is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. In a clinical trial with Apri (desogestrel and ethinyl estradiol tablets USP), 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. This rate includes patients who did not take the drug correctly. Table 1: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF TYPICAL USE AND THE FIRST YEAR OF PERFECT USE OF CONTRACEPTION AND THE PERCENTAGE CONTINUING USE AT THE END OF THE FIRST YEAR. UNITED STATES. Apri (desogestrel and ethinyl estradiol tablets USP) has not been studied for and is not indicated for use in emergency contraception.",
      "Description": "Apri® (desogestrel and ethinyl estradiol tablets USP) blister cards provide an oral contraceptive regimen of 21 rose-colored, round tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en-20-yn-17-ol) and 0.03 mg ethinyl estradiol, USP (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol). Inactive ingredients include colloidal silicon dioxide, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, hydroxypropyl methylcellulose, lactose monohydrate, polyethylene glycol, polysorbate 80, povidone, pregelatinized corn starch, stearic acid, titanium dioxide, and vitamin E. Apri blister cards also contain 7 white “inactive” tablets for oral administration, containing the following inactive ingredients: lactose anhydrous, magnesium stearate, microcrystalline cellulose and pregelatinized corn starch. Desogestrel. C22H30O M.W. 310.48. Ethinyl Estradiol, USP. C20H24O2 M.W. 296.40. The 21 rose-colored tablets meet USP Dissolution Test 2."
    },
    {
      "NDCCode": "0555-9050-58",
      "PackageDescription": "6 POUCH in 1 CARTON (0555-9050-58)  / 1 BLISTER PACK in 1 POUCH (0555-9050-79)  / 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "00555-9050-58",
      "ProductNDC": "0555-9050",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Kariva",
      "NonProprietaryName": "Desogestrel/ethinyl Estradiol And Ethinyl Estradiol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20020408",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075863",
      "LabelerName": "Teva Pharmaceuticals USA, Inc.",
      "Status": "Active",
      "LastUpdate": "2024-04-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20020408",
      "SamplePackage": "N",
      "IndicationAndUsage": "Kariva® (desogestrel/ethinyl estradiol and ethinyl estradiol tablets USP) is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. a) Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. b) Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. c) Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. d) The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. e) Foams, creams, gels, vaginal suppositories, and vaginal film. f) Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. g) With spermicidal cream or jelly. h) Without spermicides.",
      "Description": "Kariva® (desogestrel/ethinyl estradiol and ethinyl estradiol tablets USP) provides an oral contraceptive regimen of 21 white, round tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en-20-yn-17-ol), 0.02 mg ethinyl estradiol, USP (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol), and inactive ingredients which include colloidal silicon dioxide, hypromellose, lactose monohydrate, polyethylene glycol, povidone, pregelatinized corn starch, stearic acid, and vitamin E, followed by 2 inert light-green, round tablets with the following inactive ingredients: FD&C blue no. 1 aluminum lake, FD&C yellow no. 6 aluminum lake, D&C yellow no. 10 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized corn starch. Kariva® also contains 5 light-blue, round tablets containing 0.01 mg ethinyl estradiol, USP (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol) and inactive ingredients which include colloidal silicon dioxide, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, hypromellose, lactose monohydrate, polydextrose, polyethylene glycol, povidone, pregelatinized corn starch, stearic acid, titanium dioxide, triacetin and vitamin E. The structural formulas are as follows. DESOGESTREL. C22H30O M.W. 310.48. ETHINYL ESTRADIOL, USP. C20H24O2 M.W. 296.40. The 21 white tablets meet USP Dissolution Test 2."
    },
    {
      "NDCCode": "16714-404-01",
      "PackageDescription": "1 BLISTER PACK in 1 PACKET (16714-404-01)  / 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "16714-0404-01",
      "ProductNDC": "16714-404",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pimtrea",
      "NonProprietaryName": "Desogestrel/ethinyl Estradiol And Ethinyl Estradiol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20130801",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091247",
      "LabelerName": "Northstar Rx LLC",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20130913",
      "SamplePackage": "N",
      "IndicationAndUsage": "PIMTREATM (Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP) is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. Adapted from Hatcher et al., 1998, Ref#1. 1 Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.2 Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.4 The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether.5 Foams, creams, gels, vaginal suppositories, and vaginal film.6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatmy and basal body temperature in the post-ovulatory phases.7 With spermicidal cream or jelly.8 Without spermicides.",
      "Description": "PimtreaTM (Desogestrel and Ethinyl Estradiol tablets, USP and Ethinyl Estradiol tablets, USP) provide an oral contraceptive regimen of 21 dark blue tablets each containing 0.15 mg desogestrel (13-ethyl­-11- methylene-18,19-dinor-17 alpha-pregn- 4-en- 20-yn-17-ol), 0.02 mg ethinyl estradiol (19-nor­- 17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol), and inactive ingredients which include: titanium dioxide, macrogol/PEG 400 NF, hydroxypropylmethylcellulose/hypromellose, FD&C Red No. 40, FD&C Yellow No. 6, FD&C Blue No. 1, vitamin E, lactose monohydrate, povidone, stearic acid and pregelatinized starch, followed by 2 white tablets with the following inactive ingredients: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol 8000, lactose, magnesium stearate and pregelatinized corn starch. PimtreaTM also contains 5 green tablets containing 0.01 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne­-3,17-diol) and inactive ingredients which include: polyvinyl alcohol, titanium dioxide, talc, macrogol/PEG, lecithin (soya), D&C Yellow No. 10, FD&C Blue No. 1, Iron Oxide Yellow, FD&C Red No. 40, lactose monohydrate, magnesium stearate and pregelatinized starch. The molecular weights for desogestrel and ethinyl estradiol are 310.48 and 296.40 respectively. The structural formulas are as follows. The 21 dark blue tablets meet USP Dissolution Test 2."
    },
    {
      "NDCCode": "16714-404-02",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (16714-404-02)  / 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "16714-0404-02",
      "ProductNDC": "16714-404",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pimtrea",
      "NonProprietaryName": "Desogestrel/ethinyl Estradiol And Ethinyl Estradiol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20130801",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091247",
      "LabelerName": "Northstar Rx LLC",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20130913",
      "SamplePackage": "N",
      "IndicationAndUsage": "PIMTREATM (Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP) is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. Adapted from Hatcher et al., 1998, Ref#1. 1 Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.2 Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.4 The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether.5 Foams, creams, gels, vaginal suppositories, and vaginal film.6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatmy and basal body temperature in the post-ovulatory phases.7 With spermicidal cream or jelly.8 Without spermicides.",
      "Description": "PimtreaTM (Desogestrel and Ethinyl Estradiol tablets, USP and Ethinyl Estradiol tablets, USP) provide an oral contraceptive regimen of 21 dark blue tablets each containing 0.15 mg desogestrel (13-ethyl­-11- methylene-18,19-dinor-17 alpha-pregn- 4-en- 20-yn-17-ol), 0.02 mg ethinyl estradiol (19-nor­- 17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol), and inactive ingredients which include: titanium dioxide, macrogol/PEG 400 NF, hydroxypropylmethylcellulose/hypromellose, FD&C Red No. 40, FD&C Yellow No. 6, FD&C Blue No. 1, vitamin E, lactose monohydrate, povidone, stearic acid and pregelatinized starch, followed by 2 white tablets with the following inactive ingredients: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol 8000, lactose, magnesium stearate and pregelatinized corn starch. PimtreaTM also contains 5 green tablets containing 0.01 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne­-3,17-diol) and inactive ingredients which include: polyvinyl alcohol, titanium dioxide, talc, macrogol/PEG, lecithin (soya), D&C Yellow No. 10, FD&C Blue No. 1, Iron Oxide Yellow, FD&C Red No. 40, lactose monohydrate, magnesium stearate and pregelatinized starch. The molecular weights for desogestrel and ethinyl estradiol are 310.48 and 296.40 respectively. The structural formulas are as follows. The 21 dark blue tablets meet USP Dissolution Test 2."
    },
    {
      "NDCCode": "16714-404-03",
      "PackageDescription": "3 BLISTER PACK in 1 CARTON (16714-404-03)  / 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "16714-0404-03",
      "ProductNDC": "16714-404",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pimtrea",
      "NonProprietaryName": "Desogestrel/ethinyl Estradiol And Ethinyl Estradiol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20130801",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091247",
      "LabelerName": "Northstar Rx LLC",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20130913",
      "SamplePackage": "N",
      "IndicationAndUsage": "PIMTREATM (Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP) is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. Adapted from Hatcher et al., 1998, Ref#1. 1 Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.2 Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.4 The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether.5 Foams, creams, gels, vaginal suppositories, and vaginal film.6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatmy and basal body temperature in the post-ovulatory phases.7 With spermicidal cream or jelly.8 Without spermicides.",
      "Description": "PimtreaTM (Desogestrel and Ethinyl Estradiol tablets, USP and Ethinyl Estradiol tablets, USP) provide an oral contraceptive regimen of 21 dark blue tablets each containing 0.15 mg desogestrel (13-ethyl­-11- methylene-18,19-dinor-17 alpha-pregn- 4-en- 20-yn-17-ol), 0.02 mg ethinyl estradiol (19-nor­- 17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol), and inactive ingredients which include: titanium dioxide, macrogol/PEG 400 NF, hydroxypropylmethylcellulose/hypromellose, FD&C Red No. 40, FD&C Yellow No. 6, FD&C Blue No. 1, vitamin E, lactose monohydrate, povidone, stearic acid and pregelatinized starch, followed by 2 white tablets with the following inactive ingredients: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol 8000, lactose, magnesium stearate and pregelatinized corn starch. PimtreaTM also contains 5 green tablets containing 0.01 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne­-3,17-diol) and inactive ingredients which include: polyvinyl alcohol, titanium dioxide, talc, macrogol/PEG, lecithin (soya), D&C Yellow No. 10, FD&C Blue No. 1, Iron Oxide Yellow, FD&C Red No. 40, lactose monohydrate, magnesium stearate and pregelatinized starch. The molecular weights for desogestrel and ethinyl estradiol are 310.48 and 296.40 respectively. The structural formulas are as follows. The 21 dark blue tablets meet USP Dissolution Test 2."
    },
    {
      "NDCCode": "16714-404-04",
      "PackageDescription": "6 BLISTER PACK in 1 CARTON (16714-404-04)  / 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "16714-0404-04",
      "ProductNDC": "16714-404",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pimtrea",
      "NonProprietaryName": "Desogestrel/ethinyl Estradiol And Ethinyl Estradiol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20130801",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091247",
      "LabelerName": "Northstar Rx LLC",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20130913",
      "SamplePackage": "N",
      "IndicationAndUsage": "PIMTREATM (Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP) is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. Adapted from Hatcher et al., 1998, Ref#1. 1 Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.2 Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.4 The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether.5 Foams, creams, gels, vaginal suppositories, and vaginal film.6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatmy and basal body temperature in the post-ovulatory phases.7 With spermicidal cream or jelly.8 Without spermicides.",
      "Description": "PimtreaTM (Desogestrel and Ethinyl Estradiol tablets, USP and Ethinyl Estradiol tablets, USP) provide an oral contraceptive regimen of 21 dark blue tablets each containing 0.15 mg desogestrel (13-ethyl­-11- methylene-18,19-dinor-17 alpha-pregn- 4-en- 20-yn-17-ol), 0.02 mg ethinyl estradiol (19-nor­- 17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol), and inactive ingredients which include: titanium dioxide, macrogol/PEG 400 NF, hydroxypropylmethylcellulose/hypromellose, FD&C Red No. 40, FD&C Yellow No. 6, FD&C Blue No. 1, vitamin E, lactose monohydrate, povidone, stearic acid and pregelatinized starch, followed by 2 white tablets with the following inactive ingredients: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol 8000, lactose, magnesium stearate and pregelatinized corn starch. PimtreaTM also contains 5 green tablets containing 0.01 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne­-3,17-diol) and inactive ingredients which include: polyvinyl alcohol, titanium dioxide, talc, macrogol/PEG, lecithin (soya), D&C Yellow No. 10, FD&C Blue No. 1, Iron Oxide Yellow, FD&C Red No. 40, lactose monohydrate, magnesium stearate and pregelatinized starch. The molecular weights for desogestrel and ethinyl estradiol are 310.48 and 296.40 respectively. The structural formulas are as follows. The 21 dark blue tablets meet USP Dissolution Test 2."
    },
    {
      "NDCCode": "44567-310-10",
      "PackageDescription": "10 VIAL in 1 TRAY (44567-310-10)  / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL",
      "NDC11Code": "44567-0310-10",
      "ProductNDC": "44567-310",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Penicillin G Potassium",
      "NonProprietaryName": "Penicillin G Potassium",
      "DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
      "RouteName": "INTRAMUSCULAR; INTRAVENOUS",
      "StartMarketingDate": "20120510",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065149",
      "LabelerName": "WG Critical Care, LLC",
      "SubstanceName": "PENICILLIN G POTASSIUM",
      "StrengthNumber": "1000000",
      "StrengthUnit": "[iU]/1",
      "Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
      "Status": "Active",
      "LastUpdate": "2026-09-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20120510",
      "SamplePackage": "N",
      "IndicationAndUsage": "Therapy: Penicillin G Potassium for Injection, USP is indicated in the treatment of serious infections caused by susceptible strains of the designated microorganisms in the conditions listed below. Appropriate culture and susceptibility tests should be done before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to penicillin G. Therapy with Penicillin G Potassium for Injection, USP may be initiated before results of such tests are known when there is reason to believe the infection may involve any of the organisms listed below, however, once these results become available, appropriate therapy should be continued. To reduce the development of drug-resistant bacteria and maintain effectiveness of Penicillin G Potassium for Injection, USP and other antibacterial drugs, Penicillin G Potassium for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
      "Description": "Penicillin G Potassium for Injection, USP is a natural penicillin. Penicillin G Potassium for Injection, USP is a sterile, pyrogen-free powder for reconstitution. Penicillin G Potassium for Injection, USP is an antibacterial agent for intramuscular, continuous intravenous drip, intrapleural or other local infusion, and intrathecal administration. Chemically, Penicillin G Potassium for Injection, USP is monopotassium (2S,5R,6R) -3,3-dimethyl-7- oxo-6- (2-phenylacetamido) -4-thia-1- azabicyclo (3.2.0) heptane-2-carboxylate. It has a molecular weight of 372.48 and the following structural formula. Penicillin G potassium is a colorless or white crystal, or a white crystalline powder which is odorless, or practically so, and moderately hygroscopic. Penicillin G potassium is very soluble in water. The pH of the reconstituted product is between 6.0-8.5. Penicillin G potassium is buffered with sodium citrate to an optimum pH. Penicillin G Potassium for Injection, USP is supplied in vials equivalent to 1,000,000 units (1 million units), 5,000,000 units (5 million units), for intramuscular and intravenous use or 20,000,000 units (20 million units), for intravenous use only, of penicillin G as the potassium salt. Each million units contains approximately 6.9 milligrams of sodium (0.3 mEq) and 65.8 milligrams of potassium (1.68 mEq)."
    },
    {
      "NDCCode": "50090-1395-0",
      "PackageDescription": "1 KIT in 1 KIT (50090-1395-0) ",
      "NDC11Code": "50090-1395-00",
      "ProductNDC": "50090-1395",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Viorele",
      "NonProprietaryName": "Desogestrel And Ethinyl Estradiol And Ethinyl Estradiol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20120404",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091346",
      "LabelerName": "A-S Medication Solutions",
      "Status": "Active",
      "LastUpdate": "2026-06-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20141128",
      "SamplePackage": "N",
      "Description": "VIORELE® (desogestrel and ethinyl estradiol tablets, USP and ethinyl estradiol tablets, USP) provides an oral contraceptive regimen of 21 white to off-white, round tablets each containing 0.15 mg desogestrel, USP (13-ethyl-11- methylene-18,19-dinor-17 alpha-pregn- 4-en- 20-yn-17-ol), 0.02 mg ethinyl estradiol, USP (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol), and inactive ingredients which include vitamin E, potato starch, povidone, isopropyl alcohol, colloidal silicon dioxide, stearic acid, lactose, hypromellose, titanium dioxide, macrogol, talc, followed by 2 inert pale green to yellowish green, round tablets with following inactive ingredients: lactose, starch, magnesium stearate, hypromellose, titanium dioxide, macrogol, talc, iron oxide yellow, FD&C blue No. 2 indigo carmine aluminum lake. VIORELE® also contains 5 light yellow to yellow, round tablets containing 0.01 mg ethinyl estradiol, USP (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3, 17-diol) and inactive ingredients which include vitamin E, lactose, potato starch, povidone, isopropyl alcohol, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, macrogol, talc, iron oxide yellow. The molecular weights for desogestrel, USP and ethinyl estradiol, USP are 310.48 g/mol and 296.40 g/mol respectively. The structural formulas are as follows."
    },
    {
      "NDCCode": "50090-2481-0",
      "PackageDescription": "1 KIT in 1 KIT (50090-2481-0) ",
      "NDC11Code": "50090-2481-00",
      "ProductNDC": "50090-2481",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Apri",
      "ProprietaryNameSuffix": "28 Day",
      "NonProprietaryName": "Desogestrel And Ethinyl Estradiol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "19991022",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075256",
      "LabelerName": "A-S Medication Solutions",
      "Status": "Active",
      "LastUpdate": "2024-06-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20161006",
      "SamplePackage": "N",
      "IndicationAndUsage": "Apri® (desogestrel and ethinyl estradiol tablets USP) is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. In a clinical trial with Apri (desogestrel and ethinyl estradiol tablets USP), 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. This rate includes patients who did not take the drug correctly. Table 1: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF TYPICAL USE AND THE FIRST YEAR OF PERFECT USE OF CONTRACEPTION AND THE PERCENTAGE CONTINUING USE AT THE END OF THE FIRST YEAR. UNITED STATES. Apri (desogestrel and ethinyl estradiol tablets USP) has not been studied for and is not indicated for use in emergency contraception.",
      "Description": "Apri® (desogestrel and ethinyl estradiol tablets USP) blister cards provide an oral contraceptive regimen of 21 rose-colored, round tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en-20-yn-17-ol) and 0.03 mg ethinyl estradiol, USP (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol). Inactive ingredients include colloidal silicon dioxide, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, hydroxypropyl methylcellulose, lactose monohydrate, polyethylene glycol, polysorbate 80, povidone, pregelatinized corn starch, stearic acid, titanium dioxide, and vitamin E. Apri blister cards also contain 7 white “inactive” tablets for oral administration, containing the following inactive ingredients: lactose anhydrous, magnesium stearate, microcrystalline cellulose and pregelatinized corn starch. Desogestrel. C22H30O M.W. 310.48. Ethinyl Estradiol, USP. C20H24O2 M.W. 296.40. The 21 rose-colored tablets meet USP Dissolution Test 2."
    },
    {
      "NDCCode": "50268-310-12",
      "PackageDescription": "20 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-310-12)  > 1 TABLET in 1 BLISTER PACK (50268-310-11) ",
      "NDC11Code": "50268-0310-12",
      "ProductNDC": "50268-310",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fenofibrate",
      "NonProprietaryName": "Fenofibrate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160919",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090856",
      "LabelerName": "AvPAK",
      "SubstanceName": "FENOFIBRATE",
      "StrengthNumber": "48",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20160919",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "50742-310-25",
      "PackageDescription": "5 PACKET in 1 CARTON (50742-310-25)  / 1 POWDER, FOR SOLUTION in 1 PACKET (50742-310-50) ",
      "NDC11Code": "50742-0310-25",
      "ProductNDC": "50742-310",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Mafenide Acetate",
      "NonProprietaryName": "Mafenide Acetate",
      "DosageFormName": "POWDER, FOR SOLUTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20181022",
      "EndMarketingDate": "20250331",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA206716",
      "LabelerName": "Ingenus Pharmaceuticals, LLC",
      "SubstanceName": "MAFENIDE ACETATE",
      "StrengthNumber": "50",
      "StrengthUnit": "g/1",
      "Pharm_Classes": "Methylated Sulfonamide Antibacterial [EPC], Methylated Sulfonamides [EXT]",
      "Status": "Deprecated",
      "LastUpdate": "2025-04-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20181022",
      "EndMarketingDatePackage": "20250331",
      "SamplePackage": "N",
      "IndicationAndUsage": "Mafenide Acetate for 5% Topical Solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds.",
      "Description": "Mafenide Acetate, USP is a synthetic antimicrobial agent designated chemically as α-amino-p-toluenesulfonamide monoacetate. It has the following structural formula. Mafenide Acetate, USP is a white, crystalline powder which is freely soluble in water. Mafenide Acetate for 5% Topical Solution is provided in packets containing 50 g of sterile Mafenide Acetate to be reconstituted in 1000 mL of Sterile Water for Irrigation, USP or 0.9% Sodium Chloride Irrigation, USP. After mixing, the solution contains 5% w/v of Mafenide Acetate. The solution is an antimicrobial preparation suitable for topical administration. The solution is not for injection. The reconstituted solution may be held up to 28 days after preparation if stored in unopened containers. ONCE A CONTAINER IS OPENED, ANY UNUSED PORTION SHOULD BE DISCARDED AFTER 48 HOURS. Store the reconstituted solution at 20° to 25°C (68° to 77°F). Limited storage periods at 15° to 30°C (59° to 86°F) are acceptable."
    },
    {
      "NDCCode": "51662-1566-1",
      "PackageDescription": "250 mL in 1 BAG (51662-1566-1) ",
      "NDC11Code": "51662-1566-01",
      "ProductNDC": "51662-1566",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dobutamine Hydrochloride",
      "NonProprietaryName": "Dobutamine Hydrochloride",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20210710",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020255",
      "LabelerName": "HF Acquisition Co LLC, DBA HealthFirst",
      "SubstanceName": "DOBUTAMINE HYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/100mL",
      "Pharm_Classes": "Adrenergic beta-Agonists [MoA], beta-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-02-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210710",
      "SamplePackage": "N",
      "IndicationAndUsage": "Dobutamine Hydrochloride in 5% Dextrose Injection is indicated when parenteral therapy is necessary for inotropic support in the short-term treatment of patients with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures. Experience with intravenous dobutamine in controlled trials does not extend beyond 48 hours of repeated boluses and/or continuous infusions. Whether given orally, continuously intravenously, or intermittently intravenously, neither dobutamine nor any other cyclic-AMP-dependent inotrope has been shown in controlled trials to be safe or effective in the long-term treatment of congestive heart failure. In controlled trials of chronic oral therapy with various such agents, symptoms were not consistently alleviated, and the cyclic-AMP-dependent inotropes were consistently associated with increased risks of hospitalization and death. Patients with NYHA Class IV symptoms appeared to be at particular risk.",
      "Description": "Dobutamine Hydrochloride in 5% Dextrose Injection is a sterile, nonpyrogenic solution of Dobutamine Hydrochloride, USP and Dextrose, USP in Water for Injection, USP. Dobutamine hydrochloride is chemically designated as (±)-4-[2-[[3-(p-hydroxyphenyl)-1-methylpropyl]amino]ethyl]-pyrocatechol hydrochloride. It is a synthetic catecholamine. Dextrose Hydrous, USP is chemically designated as D-Glucopyranose monohydrate. Structural formulas are shown below. Dobutamine Hydrochloride, USP. (D-Glucopyranose monohydrate) Dextrose Hydrous, USP. Dobutamine Hydrochloride in 5% Dextrose Injection is intended for intravenous use only. It contains no antimicrobial agents. The pH is adjusted with sodium hydroxide and/or hydrochloric acid. Sodium bisulfite is added as a stabilizer. The solution is intended for single use only. When smaller doses are required, the unused portion should be discarded. Composition, osmolarity, pH and caloric content are given in Table 1. * Approximately 5 mEq/L sodium bisulfite is added as a stabilizer. † Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. Administration of substantially hypertonic solutions (≥ 600 mOsmol/L) may cause vein damage. This VIAFLEX PLUS plastic container is fabricated from a specially formulated polyvinyl chloride (PL 2207 Plastic). VIAFLEX containers, including VIAFLEX PLUS containers, are made of flexible plastic and are for parenteral use. VIAFLEX PLUS on the container indicates the presence of a drug additive in a drug vehicle. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies."
    },
    {
      "NDCCode": "53002-1600-1",
      "PackageDescription": "1 BLISTER PACK in 1 PACKAGE (53002-1600-1)  > 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "53002-1600-01",
      "ProductNDC": "53002-1600",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Azurette",
      "NonProprietaryName": "Desogestrel/ethinyl Estradiol And Ethinyl Estradiol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20161114",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075863",
      "LabelerName": "RPK Pharmaceuticals, Inc.",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20170901",
      "SamplePackage": "N",
      "IndicationAndUsage": "Azurette® (desogestrel/ethinyl estradiol and ethinyl estradiol tablets USP) is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. TABLE II: Percentage of women experiencing an unintended pregnancy during the first year of typical use and the first year of perfect use of contraception and the percentage continuing use at the end of the first year, United States.",
      "Description": "Azurette® (desogestrel/ethinyl estradiol and ethinyl estradiol tablets USP) provides an oral contraceptive regimen of 21 white, round tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn- 4-en- 20-yn-17-ol), 0.02 mg ethinyl estradiol, USP (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol), and inactive ingredients which include colloidal silicon dioxide, hypromellose, lactose monohydrate, polyethylene glycol, povidone, pregelatinized corn starch, stearic acid, and vitamin E, followed by 2 inert light-green, round tablets with the following inactive ingredients: FD&C blue no. 1 aluminum lake, FD&C yellow no. 6 aluminum lake, D&C yellow no. 10 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized corn starch. Azurette also contains 5 light-blue, round tablets containing 0.01 mg ethinyl estradiol, USP (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol) and inactive ingredients which include colloidal silicon dioxide, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, hypromellose, lactose monohydrate, polydextrose, polyethylene glycol, povidone, pregelatinized corn starch, stearic acid, titanium dioxide, triacetin and vitamin E. The structural formulas are as follows. DESOGESTREL. C22H30O M.W. 310.48. ETHINYL ESTRADIOL, USP. C20H24O2 M.W. 296.40. The 21 white tablets meet USP Dissolution Test 2."
    },
    {
      "NDCCode": "53002-1600-3",
      "PackageDescription": "3 BLISTER PACK in 1 PACKAGE (53002-1600-3)  > 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "53002-1600-03",
      "ProductNDC": "53002-1600",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Azurette",
      "NonProprietaryName": "Desogestrel/ethinyl Estradiol And Ethinyl Estradiol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20161114",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075863",
      "LabelerName": "RPK Pharmaceuticals, Inc.",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20170901",
      "SamplePackage": "N",
      "IndicationAndUsage": "Azurette® (desogestrel/ethinyl estradiol and ethinyl estradiol tablets USP) is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. TABLE II: Percentage of women experiencing an unintended pregnancy during the first year of typical use and the first year of perfect use of contraception and the percentage continuing use at the end of the first year, United States.",
      "Description": "Azurette® (desogestrel/ethinyl estradiol and ethinyl estradiol tablets USP) provides an oral contraceptive regimen of 21 white, round tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn- 4-en- 20-yn-17-ol), 0.02 mg ethinyl estradiol, USP (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol), and inactive ingredients which include colloidal silicon dioxide, hypromellose, lactose monohydrate, polyethylene glycol, povidone, pregelatinized corn starch, stearic acid, and vitamin E, followed by 2 inert light-green, round tablets with the following inactive ingredients: FD&C blue no. 1 aluminum lake, FD&C yellow no. 6 aluminum lake, D&C yellow no. 10 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized corn starch. Azurette also contains 5 light-blue, round tablets containing 0.01 mg ethinyl estradiol, USP (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol) and inactive ingredients which include colloidal silicon dioxide, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, hypromellose, lactose monohydrate, polydextrose, polyethylene glycol, povidone, pregelatinized corn starch, stearic acid, titanium dioxide, triacetin and vitamin E. The structural formulas are as follows. DESOGESTREL. C22H30O M.W. 310.48. ETHINYL ESTRADIOL, USP. C20H24O2 M.W. 296.40. The 21 white tablets meet USP Dissolution Test 2."
    },
    {
      "NDCCode": "53002-1600-6",
      "PackageDescription": "6 BLISTER PACK in 1 PACKAGE (53002-1600-6)  > 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "53002-1600-06",
      "ProductNDC": "53002-1600",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Azurette",
      "NonProprietaryName": "Desogestrel/ethinyl Estradiol And Ethinyl Estradiol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20161114",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075863",
      "LabelerName": "RPK Pharmaceuticals, Inc.",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20170901",
      "SamplePackage": "N",
      "IndicationAndUsage": "Azurette® (desogestrel/ethinyl estradiol and ethinyl estradiol tablets USP) is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. TABLE II: Percentage of women experiencing an unintended pregnancy during the first year of typical use and the first year of perfect use of contraception and the percentage continuing use at the end of the first year, United States.",
      "Description": "Azurette® (desogestrel/ethinyl estradiol and ethinyl estradiol tablets USP) provides an oral contraceptive regimen of 21 white, round tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn- 4-en- 20-yn-17-ol), 0.02 mg ethinyl estradiol, USP (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol), and inactive ingredients which include colloidal silicon dioxide, hypromellose, lactose monohydrate, polyethylene glycol, povidone, pregelatinized corn starch, stearic acid, and vitamin E, followed by 2 inert light-green, round tablets with the following inactive ingredients: FD&C blue no. 1 aluminum lake, FD&C yellow no. 6 aluminum lake, D&C yellow no. 10 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized corn starch. Azurette also contains 5 light-blue, round tablets containing 0.01 mg ethinyl estradiol, USP (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol) and inactive ingredients which include colloidal silicon dioxide, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, hypromellose, lactose monohydrate, polydextrose, polyethylene glycol, povidone, pregelatinized corn starch, stearic acid, titanium dioxide, triacetin and vitamin E. The structural formulas are as follows. DESOGESTREL. C22H30O M.W. 310.48. ETHINYL ESTRADIOL, USP. C20H24O2 M.W. 296.40. The 21 white tablets meet USP Dissolution Test 2."
    },
    {
      "NDCCode": "53002-1631-1",
      "PackageDescription": "1 BLISTER PACK in 1 PACKAGE (53002-1631-1)  / 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "53002-1631-01",
      "ProductNDC": "53002-1631",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Reclipsen",
      "ProprietaryNameSuffix": "28 Day",
      "NonProprietaryName": "Desogestrel And Ethinyl Estradiol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20170101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075256",
      "LabelerName": "RPK Pharmaceuticals, Inc.",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20170901",
      "SamplePackage": "N",
      "IndicationAndUsage": "Reclipsen (desogestrel and ethinyl estradiol tablets USP) is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. In a clinical trial with Reclipsen (desogestrel and ethinyl estradiol tablets USP), 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. This rate includes patients who did not take the drug correctly. Table 1: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF TYPICAL USE AND THE FIRST YEAR OF PERFECT USE OF CONTRACEPTION AND THE PERCENTAGE CONTINUING USE AT THE END OF THE FIRST YEAR. UNITED STATES. Reclipsen (desogestrel and ethinyl estradiol tablets USP) has not been studied for and is not indicated for use in emergency contraception.",
      "Description": "Reclipsen (desogestrel and ethinyl estradiol tablets USP) blister cards provide an oral contraceptive regimen of 21 rose-colored, round tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en-20-yn-17-ol) and 0.03 mg ethinyl estradiol, USP (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol). Inactive ingredients include colloidal silicon dioxide, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, hydroxypropyl methylcellulose, lactose monohydrate, polyethylene glycol, polysorbate 80, povidone, pregelatinized corn starch, stearic acid, titanium dioxide, and vitamin E. Reclipsen blister cards also contain 7 white “inactive” tablets for oral administration, containing the following inactive ingredients: lactose anhydrous, magnesium stearate, microcrystalline cellulose and pregelatinized corn starch. Desogestrel. C22H30O M.W. 310.48. Ethinyl Estradiol, USP. C20H24O2 M.W. 296.40. The 21 rose-colored tablets meet USP Dissolution Test 2."
    },
    {
      "NDCCode": "53002-1631-3",
      "PackageDescription": "3 BLISTER PACK in 1 PACKAGE (53002-1631-3)  / 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "53002-1631-03",
      "ProductNDC": "53002-1631",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Reclipsen",
      "ProprietaryNameSuffix": "28 Day",
      "NonProprietaryName": "Desogestrel And Ethinyl Estradiol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20170101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075256",
      "LabelerName": "RPK Pharmaceuticals, Inc.",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20170901",
      "SamplePackage": "N",
      "IndicationAndUsage": "Reclipsen (desogestrel and ethinyl estradiol tablets USP) is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. In a clinical trial with Reclipsen (desogestrel and ethinyl estradiol tablets USP), 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. This rate includes patients who did not take the drug correctly. Table 1: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF TYPICAL USE AND THE FIRST YEAR OF PERFECT USE OF CONTRACEPTION AND THE PERCENTAGE CONTINUING USE AT THE END OF THE FIRST YEAR. UNITED STATES. Reclipsen (desogestrel and ethinyl estradiol tablets USP) has not been studied for and is not indicated for use in emergency contraception.",
      "Description": "Reclipsen (desogestrel and ethinyl estradiol tablets USP) blister cards provide an oral contraceptive regimen of 21 rose-colored, round tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en-20-yn-17-ol) and 0.03 mg ethinyl estradiol, USP (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol). Inactive ingredients include colloidal silicon dioxide, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, hydroxypropyl methylcellulose, lactose monohydrate, polyethylene glycol, polysorbate 80, povidone, pregelatinized corn starch, stearic acid, titanium dioxide, and vitamin E. Reclipsen blister cards also contain 7 white “inactive” tablets for oral administration, containing the following inactive ingredients: lactose anhydrous, magnesium stearate, microcrystalline cellulose and pregelatinized corn starch. Desogestrel. C22H30O M.W. 310.48. Ethinyl Estradiol, USP. C20H24O2 M.W. 296.40. The 21 rose-colored tablets meet USP Dissolution Test 2."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"79903-310-48","ProprietaryName":"Allergy Relief","NonProprietaryName":"Diphenhydramine Hydrochloride"},{"NDCCode":"79903-310-24","ProprietaryName":"Allergy Relief","NonProprietaryName":"Diphenhydramine Hydrochloride"},{"NDCCode":"79903-155-48","ProprietaryName":"Sinus And Headache","NonProprietaryName":"Acetaminophen, Phenylephrine Hcl"},{"NDCCode":"79903-193-48","ProprietaryName":"Allergy Relief","NonProprietaryName":"Diphenhydramine Hcl"},{"NDCCode":"79903-206-02","ProprietaryName":"Advanced Firming And Anti-wrinkle Day Spf 18","NonProprietaryName":"Avobenzone 2% Octisalate 5% Octocrylene 5%"},{"NDCCode":"79903-316-17","ProprietaryName":"Equate","NonProprietaryName":"Octocrylene, Homosalate, Octisalate, Avobenzone"},{"NDCCode":"0069-1965-02","ProprietaryName":"Cutaquig","NonProprietaryName":"Immunoglobulin G"},{"NDCCode":"0093-3304-16","ProprietaryName":"Reclipsen","NonProprietaryName":"Desogestrel And Ethinyl Estradiol"},{"NDCCode":"0338-0143-03","ProprietaryName":"Dextrose And Electrolyte No. 48","NonProprietaryName":"Sodium Lactate, Potassium Chloride, Magnesium Chloride, Monobasic Potassium Phosphate, Sodium Chloride And Dextrose Monohydrate"},{"NDCCode":"0338-1055-48","ProprietaryName":"Metronidazole","NonProprietaryName":"Metronidazole"},{"NDCCode":"0378-7296-53","ProprietaryName":"Desogestrel And Ethinyl Estradiol And Ethinyl Estradiol","NonProprietaryName":"Desogestrel And Ethinyl Estradiol And Ethinyl Estradiol"},{"NDCCode":"0409-7929-48","ProprietaryName":"Lactated Ringers And Dextrose","NonProprietaryName":"Sodium Chloride, Sodium Lactate, Potassium Chloride, Calcium Chloride, And Dextrose Monohydrate"},{"NDCCode":"0409-7953-48","ProprietaryName":"Lactated Ringers","NonProprietaryName":"Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride"},{"NDCCode":"0555-9043-58","ProprietaryName":"Apri","NonProprietaryName":"Desogestrel And Ethinyl Estradiol"},{"NDCCode":"0555-9050-58","ProprietaryName":"Kariva","NonProprietaryName":"Desogestrel/ethinyl Estradiol And Ethinyl Estradiol"},{"NDCCode":"16714-404-01","ProprietaryName":"Pimtrea","NonProprietaryName":"Desogestrel/ethinyl Estradiol And Ethinyl Estradiol"},{"NDCCode":"16714-404-02","ProprietaryName":"Pimtrea","NonProprietaryName":"Desogestrel/ethinyl Estradiol And Ethinyl Estradiol"},{"NDCCode":"16714-404-03","ProprietaryName":"Pimtrea","NonProprietaryName":"Desogestrel/ethinyl Estradiol And Ethinyl Estradiol"},{"NDCCode":"16714-404-04","ProprietaryName":"Pimtrea","NonProprietaryName":"Desogestrel/ethinyl Estradiol And Ethinyl Estradiol"},{"NDCCode":"44567-310-10","ProprietaryName":"Penicillin G Potassium","NonProprietaryName":"Penicillin G Potassium"},{"NDCCode":"50090-1395-0","ProprietaryName":"Viorele","NonProprietaryName":"Desogestrel And Ethinyl Estradiol And Ethinyl Estradiol"},{"NDCCode":"50090-2481-0","ProprietaryName":"Apri","NonProprietaryName":"Desogestrel And Ethinyl Estradiol"},{"NDCCode":"50268-310-12","ProprietaryName":"Fenofibrate","NonProprietaryName":"Fenofibrate"},{"NDCCode":"50742-310-25","ProprietaryName":"Mafenide Acetate","NonProprietaryName":"Mafenide Acetate"},{"NDCCode":"51662-1566-1","ProprietaryName":"Dobutamine Hydrochloride","NonProprietaryName":"Dobutamine Hydrochloride"},{"NDCCode":"53002-1600-1","ProprietaryName":"Azurette","NonProprietaryName":"Desogestrel/ethinyl Estradiol And Ethinyl Estradiol"},{"NDCCode":"53002-1600-3","ProprietaryName":"Azurette","NonProprietaryName":"Desogestrel/ethinyl Estradiol And Ethinyl Estradiol"},{"NDCCode":"53002-1600-6","ProprietaryName":"Azurette","NonProprietaryName":"Desogestrel/ethinyl Estradiol And Ethinyl Estradiol"},{"NDCCode":"53002-1631-1","ProprietaryName":"Reclipsen","NonProprietaryName":"Desogestrel And Ethinyl Estradiol"},{"NDCCode":"53002-1631-3","ProprietaryName":"Reclipsen","NonProprietaryName":"Desogestrel And Ethinyl Estradiol"}]}
                    

<NDCList><NDC><NDCCode>79903-310-48</NDCCode><ProprietaryName>Allergy Relief</ProprietaryName><NonProprietaryName>Diphenhydramine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>79903-310-24</NDCCode><ProprietaryName>Allergy Relief</ProprietaryName><NonProprietaryName>Diphenhydramine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>79903-155-48</NDCCode><ProprietaryName>Sinus And Headache</ProprietaryName><NonProprietaryName>Acetaminophen, Phenylephrine Hcl</NonProprietaryName></NDC><NDC><NDCCode>79903-193-48</NDCCode><ProprietaryName>Allergy Relief</ProprietaryName><NonProprietaryName>Diphenhydramine Hcl</NonProprietaryName></NDC><NDC><NDCCode>79903-206-02</NDCCode><ProprietaryName>Advanced Firming And Anti-wrinkle Day Spf 18</ProprietaryName><NonProprietaryName>Avobenzone 2% Octisalate 5% Octocrylene 5%</NonProprietaryName></NDC><NDC><NDCCode>79903-316-17</NDCCode><ProprietaryName>Equate</ProprietaryName><NonProprietaryName>Octocrylene, Homosalate, Octisalate, Avobenzone</NonProprietaryName></NDC><NDC><NDCCode>0069-1965-02</NDCCode><ProprietaryName>Cutaquig</ProprietaryName><NonProprietaryName>Immunoglobulin G</NonProprietaryName></NDC><NDC><NDCCode>0093-3304-16</NDCCode><ProprietaryName>Reclipsen</ProprietaryName><NonProprietaryName>Desogestrel And Ethinyl Estradiol</NonProprietaryName></NDC><NDC><NDCCode>0338-0143-03</NDCCode><ProprietaryName>Dextrose And Electrolyte No. 48</ProprietaryName><NonProprietaryName>Sodium Lactate, Potassium Chloride, Magnesium Chloride, Monobasic Potassium Phosphate, Sodium Chloride And Dextrose Monohydrate</NonProprietaryName></NDC><NDC><NDCCode>0338-1055-48</NDCCode><ProprietaryName>Metronidazole</ProprietaryName><NonProprietaryName>Metronidazole</NonProprietaryName></NDC><NDC><NDCCode>0378-7296-53</NDCCode><ProprietaryName>Desogestrel And Ethinyl Estradiol And Ethinyl Estradiol</ProprietaryName><NonProprietaryName>Desogestrel And Ethinyl Estradiol And Ethinyl Estradiol</NonProprietaryName></NDC><NDC><NDCCode>0409-7929-48</NDCCode><ProprietaryName>Lactated Ringers And Dextrose</ProprietaryName><NonProprietaryName>Sodium Chloride, Sodium Lactate, Potassium Chloride, Calcium Chloride, And Dextrose Monohydrate</NonProprietaryName></NDC><NDC><NDCCode>0409-7953-48</NDCCode><ProprietaryName>Lactated Ringers</ProprietaryName><NonProprietaryName>Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride</NonProprietaryName></NDC><NDC><NDCCode>0555-9043-58</NDCCode><ProprietaryName>Apri</ProprietaryName><NonProprietaryName>Desogestrel And Ethinyl Estradiol</NonProprietaryName></NDC><NDC><NDCCode>0555-9050-58</NDCCode><ProprietaryName>Kariva</ProprietaryName><NonProprietaryName>Desogestrel/ethinyl Estradiol And Ethinyl Estradiol</NonProprietaryName></NDC><NDC><NDCCode>16714-404-01</NDCCode><ProprietaryName>Pimtrea</ProprietaryName><NonProprietaryName>Desogestrel/ethinyl Estradiol And Ethinyl Estradiol</NonProprietaryName></NDC><NDC><NDCCode>16714-404-02</NDCCode><ProprietaryName>Pimtrea</ProprietaryName><NonProprietaryName>Desogestrel/ethinyl Estradiol And Ethinyl Estradiol</NonProprietaryName></NDC><NDC><NDCCode>16714-404-03</NDCCode><ProprietaryName>Pimtrea</ProprietaryName><NonProprietaryName>Desogestrel/ethinyl Estradiol And Ethinyl Estradiol</NonProprietaryName></NDC><NDC><NDCCode>16714-404-04</NDCCode><ProprietaryName>Pimtrea</ProprietaryName><NonProprietaryName>Desogestrel/ethinyl Estradiol And Ethinyl Estradiol</NonProprietaryName></NDC><NDC><NDCCode>44567-310-10</NDCCode><ProprietaryName>Penicillin G Potassium</ProprietaryName><NonProprietaryName>Penicillin G Potassium</NonProprietaryName></NDC><NDC><NDCCode>50090-1395-0</NDCCode><ProprietaryName>Viorele</ProprietaryName><NonProprietaryName>Desogestrel And Ethinyl Estradiol And Ethinyl Estradiol</NonProprietaryName></NDC><NDC><NDCCode>50090-2481-0</NDCCode><ProprietaryName>Apri</ProprietaryName><NonProprietaryName>Desogestrel And Ethinyl Estradiol</NonProprietaryName></NDC><NDC><NDCCode>50268-310-12</NDCCode><ProprietaryName>Fenofibrate</ProprietaryName><NonProprietaryName>Fenofibrate</NonProprietaryName></NDC><NDC><NDCCode>50742-310-25</NDCCode><ProprietaryName>Mafenide Acetate</ProprietaryName><NonProprietaryName>Mafenide Acetate</NonProprietaryName></NDC><NDC><NDCCode>51662-1566-1</NDCCode><ProprietaryName>Dobutamine Hydrochloride</ProprietaryName><NonProprietaryName>Dobutamine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>53002-1600-1</NDCCode><ProprietaryName>Azurette</ProprietaryName><NonProprietaryName>Desogestrel/ethinyl Estradiol And Ethinyl Estradiol</NonProprietaryName></NDC><NDC><NDCCode>53002-1600-3</NDCCode><ProprietaryName>Azurette</ProprietaryName><NonProprietaryName>Desogestrel/ethinyl Estradiol And Ethinyl Estradiol</NonProprietaryName></NDC><NDC><NDCCode>53002-1600-6</NDCCode><ProprietaryName>Azurette</ProprietaryName><NonProprietaryName>Desogestrel/ethinyl Estradiol And Ethinyl Estradiol</NonProprietaryName></NDC><NDC><NDCCode>53002-1631-1</NDCCode><ProprietaryName>Reclipsen</ProprietaryName><NonProprietaryName>Desogestrel And Ethinyl Estradiol</NonProprietaryName></NDC><NDC><NDCCode>53002-1631-3</NDCCode><ProprietaryName>Reclipsen</ProprietaryName><NonProprietaryName>Desogestrel And Ethinyl Estradiol</NonProprietaryName></NDC></NDCList>