RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "75907-085-28",
      "PackageDescription": "1 BLISTER PACK in 1 PACKET (75907-085-28)  / 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "75907-0085-28",
      "ProductNDC": "75907-085",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Necon",
      "NonProprietaryName": "Norethindrone And Ethinyl Estradiol",
      "DosageFormName": "KIT",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240401",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091204",
      "LabelerName": "Dr. Reddy's Laboratories Inc.",
      "Status": "Active",
      "LastUpdate": "2024-04-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240401",
      "SamplePackage": "N",
      "IndicationAndUsage": "Necon 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 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 methods can result in lower failure rates. Necon has not been studied for and is not indicated for use in emergency contraception."
    },
    {
      "NDCCode": "75907-085-32",
      "PackageDescription": "3 BLISTER PACK in 1 CARTON (75907-085-32)  / 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "75907-0085-32",
      "ProductNDC": "75907-085",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Necon",
      "NonProprietaryName": "Norethindrone And Ethinyl Estradiol",
      "DosageFormName": "KIT",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240401",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091204",
      "LabelerName": "Dr. Reddy's Laboratories Inc.",
      "Status": "Active",
      "LastUpdate": "2024-04-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240401",
      "SamplePackage": "N",
      "IndicationAndUsage": "Necon 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 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 methods can result in lower failure rates. Necon has not been studied for and is not indicated for use in emergency contraception."
    },
    {
      "NDCCode": "59779-085-99",
      "PackageDescription": "1 TUBE in 1 CARTON (59779-085-99)  > 28.4 g in 1 TUBE",
      "NDC11Code": "59779-0085-99",
      "ProductNDC": "59779-085",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Povidone Iodine",
      "NonProprietaryName": "Povione Iodine",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20080730",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "CVS Pharmacy",
      "SubstanceName": "POVIDONE-IODINE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/10g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Section from Directions portion of tube label follows:Directions - clean the affected area and dry thoroughly- apply a small amount of this product on the area 1 to 3 timesdaily - May be covered with a sterile bandageSection from Directions portion of carton label follows:Directions- clean the affected area and dry thoroughly - apply a small amount of this product on the area 1 to 3 times daily - May be covered with a sterile bandage."
    },
    {
      "NDCCode": "67046-085-28",
      "PackageDescription": "28 CAPSULE, GELATIN COATED in 1 BLISTER PACK (67046-085-28)",
      "NDC11Code": "67046-0085-28",
      "ProductNDC": "67046-085",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clindamycin Hydrochloride",
      "NonProprietaryName": "Clindamycin Hydrochloride",
      "DosageFormName": "CAPSULE, GELATIN COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100702",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065194",
      "LabelerName": "Contract Pharmacy Services-PA",
      "SubstanceName": "CLINDAMYCIN HYDROCHLORIDE",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the WARNING box, before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (eg, erythromycin). : 1  Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis and postsurgical vaginal cuff infection., 2  Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections., 3  Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections., 4  Pneumococci: Serious respiratory tract infections.",
      "Description": "Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules USP, intended for oral administration, contain clindamycin hydrochloride equivalent to 150 mg or 300 mg of clindamycin. In addition, they also contain the following inactive ingredients: D&C yellow # 10, FD&C blue #1, gelatin, lactose monohydrate, magnesium stearate, pregelatinized starch and titanium dioxide. The structural formula is represented below. Molecular Formula: C18H33CIN2O5SHCl. Molecular Weight: 461.45. The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4- propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside monohydrochloride."
    },
    {
      "NDCCode": "70108-085-01",
      "PackageDescription": "3 BOTTLE, SPRAY in 1 BOX (70108-085-01)  / 28 mL in 1 BOTTLE, SPRAY",
      "NDC11Code": "70108-0085-01",
      "ProductNDC": "70108-085",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Smart Care Hot Wheels Hand Sanitizer",
      "NonProprietaryName": "Ethyl Alcohol",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240615",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "505G(a)(3)",
      "LabelerName": "Ashtel Studios, Inc.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "mL/100mL",
      "Status": "Active",
      "LastUpdate": "2025-03-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240615",
      "SamplePackage": "N",
      "IndicationAndUsage": "Decreases bacteria on skin."
    },
    {
      "NDCCode": "70108-085-02",
      "PackageDescription": "28 mL in 1 BOTTLE, SPRAY (70108-085-02) ",
      "NDC11Code": "70108-0085-02",
      "ProductNDC": "70108-085",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Smart Care Hot Wheels Hand Sanitizer",
      "NonProprietaryName": "Ethyl Alcohol",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240615",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "505G(a)(3)",
      "LabelerName": "Ashtel Studios, Inc.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "mL/100mL",
      "Status": "Active",
      "LastUpdate": "2025-03-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250228",
      "SamplePackage": "N",
      "IndicationAndUsage": "Decreases bacteria on skin."
    },
    {
      "NDCCode": "75907-074-32",
      "PackageDescription": "3 BLISTER PACK in 1 CARTON (75907-074-32)  / 28 TABLET in 1 BLISTER PACK (75907-074-28) ",
      "NDC11Code": "75907-0074-32",
      "ProductNDC": "75907-074",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Camila",
      "NonProprietaryName": "Norethindrone",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240506",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076177",
      "LabelerName": "Dr. Reddy's Labratories Inc.",
      "SubstanceName": "NORETHINDRONE",
      "StrengthNumber": ".35",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Progesterone Congeners [CS], Progestin [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-05-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240506",
      "SamplePackage": "N",
      "IndicationAndUsage": "Progestin-only oral contraceptives are indicated for the prevention of pregnancy.",
      "Description": "Each light pink Camila® tablet provides a continuous oral contraceptive regimen of 0.35 mg norethindrone, USP daily, and has the following inactive ingredients: corn starch, FD&C red no. 40 aluminum lake, lactose monohydrate, magnesium stearate, povidone and sodium starch glycolate. The chemical name for norethindrone is 17-Hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one. The structural formula follows. Therapeutic class = oral contraceptive. Meets USP Dissolution Test 2."
    },
    {
      "NDCCode": "75907-075-32",
      "PackageDescription": "3 BLISTER PACK in 1 CARTON (75907-075-32)  / 28 TABLET in 1 BLISTER PACK (75907-075-28) ",
      "NDC11Code": "75907-0075-32",
      "ProductNDC": "75907-075",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Errin",
      "NonProprietaryName": "Norethindrone",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240310",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076225",
      "LabelerName": "Dr. Reddy's Labratories Inc.",
      "SubstanceName": "NORETHINDRONE",
      "StrengthNumber": ".35",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Progesterone Congeners [CS], Progestin [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-03-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240310",
      "SamplePackage": "N",
      "IndicationAndUsage": "Progestin-only oral contraceptives are indicated for the prevention of pregnancy.",
      "Description": "Norethindrone, USP is a white to creamy white, odorless, crystalline powder. It is stable in air. Practically insoluble in water; soluble in chloroform and in dioxane; sparingly soluble in alcohol; slightly soluble in ether. The chemical name for norethindrone is 17-Hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one. The structural formula is as follows. C20H26O2 M.W.298.42. Each yellow tablet contains 0.35 mg norethindrone, USP and has the following inactive ingredients: anhydrous lactose, corn starch, D&C yellow no. 10 aluminum lake, ethylcellulose aqueous dispersion, lactose monohydrate, magnesium stearate, microcrystalline cellulose and povidone. Meets USP Dissolution Test 2."
    },
    {
      "NDCCode": "75907-078-55",
      "PackageDescription": "5 BLISTER PACK in 1 CARTON (75907-078-55)  / 1 KIT in 1 BLISTER PACK (75907-078-28) ",
      "NDC11Code": "75907-0078-55",
      "ProductNDC": "75907-078",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Low-ogestrel",
      "NonProprietaryName": "Norgestrel And Ethinyl Estradiol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20240930",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075288",
      "LabelerName": "Dr. Reddy's Laboratories Inc.",
      "Status": "Deprecated",
      "LastUpdate": "2025-07-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20240930",
      "SamplePackage": "N",
      "IndicationAndUsage": "Low-Ogestrel is indicated for use by females of reproductive potential to prevent pregnancy. In a study of 1,287 women with a total of 11,085 cycles or 852.7 women-years of usage, the pregnancy rate in women age 15-40 years was approximately 1 pregnancy per 100 women-years of use.",
      "Description": "Low-Ogestrel is a combination oral contraceptive containing the progestational compound norgestrel and the estrogenic compound ethinyl estradiol. Norgestrel is designated as (2) (±)-13­ Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one and ethinyl estradiol is designated as (19-nor-17α-pregna-1,3,5 (10)-trien-20-yne-3,17-diol). Each white active Low-Ogestrel tablet contains 0.3 mg norgestrel and 0.03 mg ethinyl estradiol and the following inert ingredients: croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, and povidone. Each peach placebo tablet contains only the following inert ingredients: anhydrous lactose, FD&C Yellow No. 6 Lake, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Each pill pack contains 21 white active tablets and 7 peach inert tablets."
    },
    {
      "NDCCode": "75907-079-55",
      "PackageDescription": "5 BLISTER PACK in 1 CARTON (75907-079-55)  / 1 KIT in 1 BLISTER PACK (75907-079-28) ",
      "NDC11Code": "75907-0079-55",
      "ProductNDC": "75907-079",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lutera",
      "NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20240930",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076625",
      "LabelerName": "Dr. Reddy's Laboratories Inc.",
      "Status": "Deprecated",
      "LastUpdate": "2025-07-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20240930",
      "SamplePackage": "N",
      "IndicationAndUsage": "Lutera 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 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, the IUD, and Norplant ®System, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. In a clinical trial with levonorgestrel and ethinyl estradiol tablets, 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported. This represents an overall pregnancy rate of 0.84 per 100 woman-years. This rate includes patients who did not take the drug correctly. One or more pills were missed during 1,479 (18.8%) of the 7,870 cycles; thus all tablets were taken during 6,391 (81.2%) of the 7,870 cycles. Of the total 7,870 cycles, a total of 150 cycles were excluded from the calculation of the Pearl index due to the use of backup contraception and/or missing 3 or more consecutive pills.",
      "Description": "Each active, white tablet (21) contains 0.1 mg of levonorgestrel, d (-)-13β-ethyl-17α-ethinyl-17β- hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, 17α-ethinyl- 1,3,5(10)-estratriene-3,17β-diol. The inactive ingredients present are croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Each inactive, peach tablet (7) contains the following inactive ingredients: FD&C Yellow #6, lactose anhydrous, lactose monohydrate, magnesium stearate, and microcrystalline cellulose."
    },
    {
      "NDCCode": "75907-081-28",
      "PackageDescription": "1 BLISTER PACK in 1 PACKET (75907-081-28)  / 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "75907-0081-28",
      "ProductNDC": "75907-081",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Microgestin Fe 1.5/30",
      "NonProprietaryName": "Norethindrone Acetate/ethinyl Estradiol And Ferrous Fumarate",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20240501",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091453",
      "LabelerName": "Dr. Reddy�s Laboratories Inc",
      "Status": "Active",
      "LastUpdate": "2024-05-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240501",
      "SamplePackage": "N",
      "IndicationAndUsage": "Microgestin Fe 1.5/30 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 I 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 methods can result in lower failure rates.",
      "Description": "Microgestin Fe 1.5/30 is a progestogen-estrogen combination. Microgestin Fe 1.5/30 provides a continuous dosage regimen consisting of 21 yellow oral contraceptive tablets and seven brown ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose. Each yellow tablet contains norethindrone acetate (17 alpha-ethinyl-19-nortestosterone acetate), 1.5 mg; ethinyl estradiol (17 alpha-ethinyl-1,3,5(10)-estratriene-3, 17 beta-diol), 30 mcg. Also contains polyvinyl alcohol, titanium dioxide, talc, macrogol/polyethylglycol 3350 , lecithin (soya), iron oxide yellow, FD&C Blue No.2 Aluminum Lake, D&C Yellow No.10 Aluminum Lake, FD&C Yellow No.6 Aluminum Lake, lactose, magnesium stearate and pregelatinized corn starch. The structural formulas are as follows. Each brown placebo tablet contains ferrous fumarate, polyvinyl alcohol, talc, macrogol/polyethylene glycol 3350 NF, lecithin (soya), iron oxide black, iron oxide yellow, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate and crospovidone. The ferrous fumarate tablets do not serve any therapeutic purpose."
    },
    {
      "NDCCode": "75907-082-28",
      "PackageDescription": "1 BLISTER PACK in 1 PACKET (75907-082-28)  / 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "75907-0082-28",
      "ProductNDC": "75907-082",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Microgestin Fe 1/20",
      "NonProprietaryName": "Norethindrone Acetate/ethinyl Estradiol And Ferrous Fumarate",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20240501",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091454",
      "LabelerName": "Dr. Reddy's Laboratories Inc.",
      "Status": "Active",
      "LastUpdate": "2024-05-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240501",
      "SamplePackage": "N",
      "IndicationAndUsage": "Microgestin Fe 1/20 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 I 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 methods can result in lower failure rates. *The authors' best guess of the percentage of women expected to experience an accidental pregnancy among couples who initiate a method (not necessarily for the first time) and who use it consistently and correctly during the first year if they do not stop for any other reason. **This term represents \"typical\" couples who initiate use of a method (not necessarily for the first time), who experience an accidental pregnancy during the first year if they do not stop use for any other reason. ***N/A--Data not available.",
      "Description": "Microgestin Fe 1/20 is a progestogen-estrogen combination. Microgestin Fe 1/20 provides a continuous dosage regimen consisting of 21 oral contraceptive tablets and seven ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose. Each pale yellow tablet contains norethindrone acetate (17 alpha-ethinyl-19-nortestosterone acetate), 1 mg; ethinyl estradiol (17 alpha-ethinyl-1,3,5(10)-estratriene-3,17 beta-diol), 20 mcg. Also contains polyvinyl alcohol, titanium dioxide, talc, macrogol/polyethylglycol 3350, lecithin (soya), D&C Yellow No.10 Aluminum Lake, FD&C Blue No.2 Aluminum Lake, FD&C Yellow No.6 Aluminum Lake, lactose, magnesium stearate and pregelatinized corn starch. The structural formulas are as follows. Each brown placebo tablet contains ferrous fumarate, polyvinyl alcohol, talc, macrogol/polyethyleneglycol 3350 NF, lecithin (soya), iron oxide black, iron oxide yellow,microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate and crospovidone.The ferrous fumarate tablets do not serve any therapeutic purpose."
    },
    {
      "NDCCode": "75907-086-28",
      "PackageDescription": "1 BLISTER PACK in 1 PACKET (75907-086-28)  / 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "75907-0086-28",
      "ProductNDC": "75907-086",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tilia Fe",
      "NonProprietaryName": "Ndac And Ee Tablets And Ferrous Fumarate Tablets",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20240601",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202962",
      "LabelerName": "Dr. Reddy�s Laboratories Inc.",
      "Status": "Active",
      "LastUpdate": "2024-06-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240601",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tilia Fe is indicated for the prevention of pregnancy in women who elect to use combined oral contraceptives as a method of contraception. Tilia Fe is indicated for the treatment of moderate acne vulgaris in females, ≥15 years of age, who have no known contraindications to combined oral contraceptive therapy, desire oral contraception, have achieved menarche, and are unresponsive to topical anti-acne medications. Tilia Fe should be used for the treatment of acne only if the patient desires a combined oral contraceptive for birth control and plans to stay on it for at least 6 months. Combined oral contraceptives are highly effective for pregnancy prevention. Table 2 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 methods can result in lower failure rates. Table 2. 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. 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 1 year. 4 The percentages 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-ovulatory and basal body temperature in the post-ovulatory phases. 7 With spermicidal cream or jelly. 8 Without spermicides. 9 The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The Food and Drug Administration has declared the following brands of combined oral contraceptives to be safe and effective for emergency contraception: Ovral® (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 4 light-orange pills), Lo/Ovral® (1 dose is 4 white pills), Triphasil® or Tri-Levlen® (1 dose is 4 yellow pills). 10 However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. Norethindrone acetate and ethinyl estradiol tablets were evaluated for the treatment of acne vulgaris in two randomized, double-blind, placebo-controlled, multicenter, Phase 3, six (28-day) cycle studies. A total of 296 patients received norethindrone acetate and ethinyl estradiol tablets and 295 received placebo. Mean age at enrollment for both groups was 24 years. At six months each study demonstrated a statistically significant difference between norethindrone acetate and ethinyl estradiol tablets and placebo for mean change from baseline in lesion counts (see Table 3 and Figure 2). Each study also demonstrated overall treatment success in the investigator's global evaluation. Patients with severe androgen excess were not studied. Table 3. Acne Vulgaris Indication Pooled Data 376-403 and 376-404 Observed Means at Six Months and at Baseline* Intent To Treat Population. *Numbers rounded to nearest integer. † Limits for 95% Confidence Interval; not adjusted for baseline differences. Norethindrone acetate and ethinyl estradiol tablet users who started with about 74 acne lesions had about 42 lesions after 6 months of treatment. Placebo users who started with about 72 acne lesions had about 49 lesions after the same duration of treatment.",
      "Description": "Tilia Fe is a graduated estrophasic combined oral contraceptive providing estrogen in a graduated sequence over a 21-day period with a constant dose of progestogen. Tilia Fe provides for a continuous dosage regimen consisting of 21 oral contraceptive tablets and seven ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose. Each pale yellow tablet contains 1 mg norethindrone acetate [(17 alpha)-17-(acetyloxy)-19-norpregna-4-en-20-yn-3-one] and 20 mcg ethinyl estradiol [(17 alpha)-19-norpregna-1,3,5(10)-trien-20-yne-3,17-diol]; each light yellow tablet contains 1 mg norethindrone acetate and 30 mcg ethinyl estradiol; and each light brown tablet contains 1mg norethindrone acetate and 35mcg ethinyl estradiol. Each pale yellow tablet contains 1 mg norethindrone acetate and 20 mcg ethinyl estradiol.Each pale yellow tablet contains the following inactive ingredients: Ethyl Cellulose, Hypromellose, Lactose Monohydrate, Pregelatinized Starch, Magnesium Stearate, Polyvinyl Alcohol, Titanium Dioxide ,Talc, Macrogol/Polyethylene Glycol, Lecithin (Soya),D&C Yellow #10 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Yellow #6 Aluminum Lake. Each light yellow tablet contains 1 mg norethindrone acetate and 30 mcg ethinyl estradiol. Each light yellow tablet contains the following inactive ingredients: Ethyl Cellulose, Hypromellose, Lactose Monohydrate, Pregelatinized Starch, Magnesium Stearate, Polyvinyl Alcohol, Titanium Dioxide , Talc , Macrogol/Polyethylene Glycol, Lecithin (Soya), D&C Yellow #10 Aluminum Lake, Iron Oxide Yellow, FD&C Yellow #6 Aluminum Lake, FD&C Blue #2 Aluminum Lake. Each light brown tablet contains 1 mg norethindrone acetate and 35 mcg ethinyl estradiol. Each light brown tablet contains the following inactive ingredients: Ethyl Cellulose, Hypromellose, Lactose Monohydrate, Pregelatinized Starch, Magnesium Stearate, Polyvinyl Alcohol, Titanium Dioxide,Talc , Macrogol/Polyethylene Glycol, Lecithin (Soya), Iron Oxide Yellow, Iron Oxide Red, Iron Oxide Black. The structural formulas are as follows. Each brown tablet contains:  Ferrous Fumarate, Micro-crystalline Cellulose, Hydroxypropyl Cellulose, Crospovidone, Magnesium Stearate, Polyvinyl Alcohol, Iron Oxide Yellow, Talc, Polyethylene Glycol 3350, Iron Oxide Red, Lecithin (Soya), Iron Oxide Black. Each Tilia Fe tablet dispenser contains five pale yellow tablets, seven light yellow tablets, nine light brown tablets, and seven brown tablets. These tablets are to be taken in the following order: one pale yellow tablet each day for five days, then one light yellow tablet each day for seven days, followed by one light brown tablet each day for nine days, and then one brown tablet each day for seven days."
    },
    {
      "NDCCode": "75907-087-28",
      "PackageDescription": "1 BLISTER PACK in 1 PACKET (75907-087-28)  / 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "75907-0087-28",
      "ProductNDC": "75907-087",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Zovia 1/35",
      "NonProprietaryName": "Ethynodiol Diacetate And Ethinyl Estradiol Tablets",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20240601",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209548",
      "LabelerName": "Dr. Reddy�s Laboratories Inc.",
      "Status": "Active",
      "LastUpdate": "2024-06-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240601",
      "SamplePackage": "N",
      "IndicationAndUsage": "Zovia 1/35 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 combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and progestogen implants and injections, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. (A) 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. (B) 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. (C) Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. (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. (I) The treatment schedule is one dose within 72 hours after unprotected intercourse and a second dose 12 hours after the first dose. The Food and Drug Administration has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral (1 dose is 2 white pills), Alesse (1 dose is 5 pink pills), Nordette or Levlen (1 dose is 2 light-orange pills), Lo/Ovral (1 dose is 4 white pills), Triphasil or Tri-Levlen (1 dose is 4 yellow pills). (J) However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches six months of age.",
      "Description": "Zovia 1/35: Each pale pink tablet contains 1 mg of ethynodiol diacetate and 35 mcg of ethinyl estradiol, and the inactive ingredients include lactose monohydrate, pregelatinized starch, vitamin e, magnesium stearate, microcrystalline cellulose, croscarmellose sodium, povidone, polyvinyl alcohol, titanium dioxide, talc, polyethylene glycol/macrogol, lecithin (soya), FD&C Red #40 aluminum lake, FD&C Blue #1 aluminum lake, and FD&C yellow #6 aluminum lake. Each white tablet in the Zovia 1/35 package is a placebo containing no active ingredients and the inactive ingredients include lactose monohydrate, magnesium stearate, pregelatinized starch, titanium dioxide, polydextrose, hypromellose, triacetin, and polyethylene glycol. The chemical name for ethynodiol diacetate is 19-Nor-17α-pregn-4-en-20-yne-3β,17-diol diacetate, and for ethinyl estradiol it is 19-Nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol. The structural formulas are as follows. Therapeutic class: Oral contraceptive."
    },
    {
      "NDCCode": "75907-089-55",
      "PackageDescription": "5 BLISTER PACK in 1 CARTON (75907-089-55)  / 1 KIT in 1 BLISTER PACK (75907-089-28) ",
      "NDC11Code": "75907-0089-55",
      "ProductNDC": "75907-089",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sronyx",
      "NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20240930",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077681",
      "LabelerName": "Dr. Reddy's Labratories Inc.",
      "Status": "Deprecated",
      "LastUpdate": "2025-07-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20240930",
      "SamplePackage": "N",
      "IndicationAndUsage": "Oral contraceptives 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 III 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 methods can result in lower failure rates.",
      "Description": "Each cycle of Sronyx ®(Levonorgestrel and Ethinyl Estradiol Tablets USP) consists of 21 white active tablets each containing 0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol; and seven peach tablets – inert. The inactive ingredients are Croscarmellose Sodium NF, Lactose Monohydrate NF, Magnesium Stearate NF, Microcrystalline Cellulose (PH 102) NF, and Povidone (K29/32) NF. Each inactive, placebo tablet contains the following inactive ingredients: FD & C Yellow #6 Lake 35-42%, Lactose Anhydrous (DT Micro) NF, Lactose Monohydrate (200M) NF, Magnesium Stearate NF and Microcrystalline Cellulose NF. Levonorgestrel has a molecular weight of 312.4 and a molecular formula of C 21H 28O 2. Ethinyl estradiol has a molecular weight of 296.4 and a molecular formula of C 20H 24O 2. The structural formulas are as follows:."
    },
    {
      "NDCCode": "75907-090-55",
      "PackageDescription": "5 BLISTER PACK in 1 CARTON (75907-090-55)  / 1 KIT in 1 BLISTER PACK (75907-090-28) ",
      "NDC11Code": "75907-0090-55",
      "ProductNDC": "75907-090",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levora",
      "NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20240930",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA073594",
      "LabelerName": "Dr. Reddy's Laboratories Inc.",
      "Status": "Deprecated",
      "LastUpdate": "2025-07-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20240930",
      "SamplePackage": "N",
      "IndicationAndUsage": "LEVORA 0.15/30-28 is indicated for use by females of reproductive potential to prevent pregnancy.",
      "Description": "LEVORA ®0.15/30-28 (levonorgestrel and ethinyl estradiol tablets) is a combination oral contraceptive (COC) consisting of 21 white active tablets, each containing 0.15 mg of levonorgestrel, a synthetic progestin and 0.03 mg of ethinyl estradiol, an estrogen, and 7 peach inert tablets (without hormones). The structural formulas for the active components are. Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-,(17α)­ (-)-. Ethinyl Estradiol is 19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3, 17-diol. Each white active tablet contains the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Each peach inert tablet contains the following inactive ingredients: FD&C Yellow No. 6 Lake, Lactose Anhydrous, Lactose Monohydrate, Magnesium Stearate and Microcrystalline Cellulose."
    },
    {
      "NDCCode": "75907-091-28",
      "PackageDescription": "1 BLISTER PACK in 1 PACKET (75907-091-28)  / 1 KIT in 1 BLISTER PACK",
      "NDC11Code": "75907-0091-28",
      "ProductNDC": "75907-091",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Azurette",
      "NonProprietaryName": "Desogestrel/ethinyl Estradiol And Ethinyl Estradiol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20240625",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091247",
      "LabelerName": "Dr. Reddy�s Laboratories Inc.",
      "Status": "Active",
      "LastUpdate": "2024-06-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240625",
      "SamplePackage": "N",
      "IndicationAndUsage": "Azurette (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 coosistent 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-ovulatory and basal body temperature in the post-ovulatory phases.7 With spermicidal cream or jelly.8 Without spermicides.",
      "Description": "Azurette (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, hydroxypropyl-methylcellulose/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. Azurette 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": "75907-189-35",
      "PackageDescription": "1 VIAL in 1 CARTON (75907-189-35)  / 10 mL in 1 VIAL",
      "NDC11Code": "75907-0189-35",
      "ProductNDC": "75907-189",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cyclophosphamide",
      "NonProprietaryName": "Cyclophosphamide",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20240620",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA212501",
      "LabelerName": "Dr. Reddy's Labratories Inc.",
      "SubstanceName": "CYCLOPHOSPHAMIDE ANHYDROUS",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2025-07-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240620",
      "SamplePackage": "N",
      "IndicationAndUsage": "Cyclophosphamide is an alkylating drug indicated for treatment of adults and pediatric patients with: 1 Malignant Diseases:malignant lymphomas: Hodgkin's disease, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitt's lymphoma; multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of ovary, retinoblastoma, breast carcinoma. (1.1).",
      "Description": "Cyclophosphamide is an alkylating drug. It is an antineoplastic drug chemically related to the nitrogen mustards. The chemical name for cyclophosphamide is 2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate, and has the following structural formula:. Cyclophosphamide has a molecular formula of C7H15Cl2N2O2PH2O and a molecular weight of 279.1. Cyclophosphamide is soluble in water, saline, or ethanol. Cyclophosphamide Injection is a 200 mg/mL sterile clear colorless solution available as 500 mg,1 g and 2 g strength vials. : 1 500 mg vial contains 534.5 mg cyclophosphamide monohydrate equivalent to 500 mg cyclophosphamide, 1.55 g Ethanol, 0.085 g Propylene Glycol, 0.085 g Polyethylene glycol 400 and 0.345 mg Monothioglycerol., 2 1 g vial contains 1069.0 mg cyclophosphamide monohydrate equivalent to 1 g cyclophosphamide, 3.1 g Ethanol, 0.17 g Propylene Glycol, 0.17 g Polyethylene glycol 400 and 0.69 mg Monothioglycerol., 3 2 g vial contains 2138.0 mg cyclophosphamide monohydrate equivalent to 2 g cyclophosphamide, 6.2 g Ethanol, 0.34 g Propylene glycol, 0.34 g Polyethylene glycol 400 and 1.38 mg Monothioglycerol."
    },
    {
      "NDCCode": "75907-190-07",
      "PackageDescription": "1 VIAL in 1 CARTON (75907-190-07)  / 5 mL in 1 VIAL",
      "NDC11Code": "75907-0190-07",
      "ProductNDC": "75907-190",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cyclophosphamide",
      "NonProprietaryName": "Cyclophosphamide",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20240620",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA212501",
      "LabelerName": "Dr. Reddy's Labratories Inc.",
      "SubstanceName": "CYCLOPHOSPHAMIDE ANHYDROUS",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2025-07-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240620",
      "SamplePackage": "N",
      "IndicationAndUsage": "Cyclophosphamide is an alkylating drug indicated for treatment of adults and pediatric patients with: 1 Malignant Diseases:malignant lymphomas: Hodgkin's disease, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitt's lymphoma; multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of ovary, retinoblastoma, breast carcinoma. (1.1).",
      "Description": "Cyclophosphamide is an alkylating drug. It is an antineoplastic drug chemically related to the nitrogen mustards. The chemical name for cyclophosphamide is 2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate, and has the following structural formula:. Cyclophosphamide has a molecular formula of C7H15Cl2N2O2PH2O and a molecular weight of 279.1. Cyclophosphamide is soluble in water, saline, or ethanol. Cyclophosphamide Injection is a 200 mg/mL sterile clear colorless solution available as 500 mg,1 g and 2 g strength vials. : 1 500 mg vial contains 534.5 mg cyclophosphamide monohydrate equivalent to 500 mg cyclophosphamide, 1.55 g Ethanol, 0.085 g Propylene Glycol, 0.085 g Polyethylene glycol 400 and 0.345 mg Monothioglycerol., 2 1 g vial contains 1069.0 mg cyclophosphamide monohydrate equivalent to 1 g cyclophosphamide, 3.1 g Ethanol, 0.17 g Propylene Glycol, 0.17 g Polyethylene glycol 400 and 0.69 mg Monothioglycerol., 3 2 g vial contains 2138.0 mg cyclophosphamide monohydrate equivalent to 2 g cyclophosphamide, 6.2 g Ethanol, 0.34 g Propylene glycol, 0.34 g Polyethylene glycol 400 and 1.38 mg Monothioglycerol."
    },
    {
      "NDCCode": "75907-191-02",
      "PackageDescription": "1 VIAL in 1 CARTON (75907-191-02)  / 2.5 mL in 1 VIAL",
      "NDC11Code": "75907-0191-02",
      "ProductNDC": "75907-191",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cyclophosphamide",
      "NonProprietaryName": "Cyclophosphamide",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20240620",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA212501",
      "LabelerName": "Dr. Reddy's Labratories Inc.",
      "SubstanceName": "CYCLOPHOSPHAMIDE ANHYDROUS",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2025-07-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240620",
      "SamplePackage": "N",
      "IndicationAndUsage": "Cyclophosphamide is an alkylating drug indicated for treatment of adults and pediatric patients with: 1 Malignant Diseases:malignant lymphomas: Hodgkin's disease, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitt's lymphoma; multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of ovary, retinoblastoma, breast carcinoma. (1.1).",
      "Description": "Cyclophosphamide is an alkylating drug. It is an antineoplastic drug chemically related to the nitrogen mustards. The chemical name for cyclophosphamide is 2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate, and has the following structural formula:. Cyclophosphamide has a molecular formula of C7H15Cl2N2O2PH2O and a molecular weight of 279.1. Cyclophosphamide is soluble in water, saline, or ethanol. Cyclophosphamide Injection is a 200 mg/mL sterile clear colorless solution available as 500 mg,1 g and 2 g strength vials. : 1 500 mg vial contains 534.5 mg cyclophosphamide monohydrate equivalent to 500 mg cyclophosphamide, 1.55 g Ethanol, 0.085 g Propylene Glycol, 0.085 g Polyethylene glycol 400 and 0.345 mg Monothioglycerol., 2 1 g vial contains 1069.0 mg cyclophosphamide monohydrate equivalent to 1 g cyclophosphamide, 3.1 g Ethanol, 0.17 g Propylene Glycol, 0.17 g Polyethylene glycol 400 and 0.69 mg Monothioglycerol., 3 2 g vial contains 2138.0 mg cyclophosphamide monohydrate equivalent to 2 g cyclophosphamide, 6.2 g Ethanol, 0.34 g Propylene glycol, 0.34 g Polyethylene glycol 400 and 1.38 mg Monothioglycerol."
    },
    {
      "NDCCode": "75907-026-01",
      "PackageDescription": "100 CAPSULE in 1 BOTTLE (75907-026-01) ",
      "NDC11Code": "75907-0026-01",
      "ProductNDC": "75907-026",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Disopyramide Phosphate",
      "NonProprietaryName": "Disopyramide Phosphate",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240315",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA070173",
      "LabelerName": "Dr. Reddy's Labratories Inc.",
      "SubstanceName": "DISOPYRAMIDE PHOSPHATE",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antiarrhythmic [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-03-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240315",
      "SamplePackage": "N",
      "IndicationAndUsage": "Disopyramide phosphate capsules are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. Because of the proarrhythmic effects of disopyramide, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of disopyramide treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.",
      "Description": "Disopyramide phosphate is an antiarrhythmic drug available for oral administration in immediate-release capsules containing 100 mg or 150 mg of disopyramide base, present as the phosphate. The base content of the phosphate salt is 77.6%. The structural formula of disopyramide phosphate is. (±)-α-[2-(Diisopropylamino)ethyl]-α-phenyl-2-pyridineacetamide phosphate (1:1). Disopyramide phosphate is freely soluble in water, and the free base (pKa 10.4) has an aqueous solubility of 1 mg/mL. The chloroform: water partition coefficient of the base is 3.1 at pH 7.2. Disopyramide phosphate is a racemic mixture of d- and l-isomers. This drug is not chemically related to other antiarrhythmic drugs. Disopyramide phosphate capsules (equivalent to 100 mg Disopyramide Base) and Disopyramide phosphate capsules (equivalent to 150 mg Disopyramide Base) contain the following inactive ingredients: magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. The capsule shells contain gelatin, methylparaben, propylparaben, and titanium dioxide. The 100 mg capsule shell also contains D&C Red No. 28, D&C Yellow No. 10, FD&C Blue No. 1 and FD&C Red No. 40. The 150 mg capsule shell also contains black iron oxide and red iron oxide."
    },
    {
      "NDCCode": "75907-027-01",
      "PackageDescription": "100 CAPSULE in 1 BOTTLE (75907-027-01) ",
      "NDC11Code": "75907-0027-01",
      "ProductNDC": "75907-027",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Disopyramide Phosphate",
      "NonProprietaryName": "Disopyramide Phosphate",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240315",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA070173",
      "LabelerName": "Dr. Reddy's Labratories Inc.",
      "SubstanceName": "DISOPYRAMIDE PHOSPHATE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antiarrhythmic [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-03-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240315",
      "SamplePackage": "N",
      "IndicationAndUsage": "Disopyramide phosphate capsules are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. Because of the proarrhythmic effects of disopyramide, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of disopyramide treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.",
      "Description": "Disopyramide phosphate is an antiarrhythmic drug available for oral administration in immediate-release capsules containing 100 mg or 150 mg of disopyramide base, present as the phosphate. The base content of the phosphate salt is 77.6%. The structural formula of disopyramide phosphate is. (±)-α-[2-(Diisopropylamino)ethyl]-α-phenyl-2-pyridineacetamide phosphate (1:1). Disopyramide phosphate is freely soluble in water, and the free base (pKa 10.4) has an aqueous solubility of 1 mg/mL. The chloroform: water partition coefficient of the base is 3.1 at pH 7.2. Disopyramide phosphate is a racemic mixture of d- and l-isomers. This drug is not chemically related to other antiarrhythmic drugs. Disopyramide phosphate capsules (equivalent to 100 mg Disopyramide Base) and Disopyramide phosphate capsules (equivalent to 150 mg Disopyramide Base) contain the following inactive ingredients: magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. The capsule shells contain gelatin, methylparaben, propylparaben, and titanium dioxide. The 100 mg capsule shell also contains D&C Red No. 28, D&C Yellow No. 10, FD&C Blue No. 1 and FD&C Red No. 40. The 150 mg capsule shell also contains black iron oxide and red iron oxide."
    },
    {
      "NDCCode": "75907-049-01",
      "PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (75907-049-01) ",
      "NDC11Code": "75907-0049-01",
      "ProductNDC": "75907-049",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Methylphenidate Hydrochloride (la)",
      "NonProprietaryName": "Methylphenidate Hydrochloride",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20241220",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA200886",
      "LabelerName": "Dr. Reddy's Laboratories Inc",
      "SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
      "DEASchedule": "CII",
      "Status": "Active",
      "LastUpdate": "2025-10-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20241220",
      "SamplePackage": "N",
      "IndicationAndUsage": "Methylphenidate hydrochloride extended-release capsules (LA) is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), in pediatric patients 6 to 12 years of age [see Clinical Studies (14)]. Limitation of UseThe use of Methylphenidate hydrochloride extended-release capsules (LA) is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)].",
      "Description": "Methylphenidate hydrochloride extended-release capsules (LA) contains methylphenidate hydrochloride USP, a CNS stimulant. Methylphenidate hydrochloride extended-release capsules (LA) is an extended-release formulation of methylphenidate for oral administration with a bi-modal release profile. Each bead-filled methylphenidate hydrochloride extended-release capsule (LA) contains half the dose as immediate-release beads and half as enteric-coated beads, thus providing an immediate release of methylphenidate and a second delayed release of methylphenidate. The active substance in methylphenidate hydrochloride extended-release capsules (LA) is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is. Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Inactive ingredients: Sugar spheres (which contain sucrose and starch (corn)), hypromellose, cellulose acetate butyrate, hypromellose acetate succinate, acetyltributyl citrate, acetone, talc, and purified water. Opaque gelatin capsules contain: titanium dioxide and gelatin. The 10mg capsule contains FD&C Green#3, FD&C#40, and FD&C Yellow #6. The 30 and 40 mg capsules contain D&C Red #28 and FD&C Blue #1. The 60 mg capsules contain iron oxide yellow and sodium lauryl sulfate. The capsules are imprinted with black ink which contains black iron oxide, shellac and potassium hydroxide. The 60 mg black imprinting ink also contains ammonium hydroxide and propylene glycol."
    },
    {
      "NDCCode": "75907-050-01",
      "PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (75907-050-01) ",
      "NDC11Code": "75907-0050-01",
      "ProductNDC": "75907-050",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Methylphenidate Hydrochloride (la)",
      "NonProprietaryName": "Methylphenidate Hydrochloride",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20241220",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078458",
      "LabelerName": "Dr. Reddy's Laboratories Inc",
      "SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
      "DEASchedule": "CII",
      "Status": "Active",
      "LastUpdate": "2025-10-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20241220",
      "SamplePackage": "N",
      "IndicationAndUsage": "Methylphenidate hydrochloride extended-release capsules (LA) is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), in pediatric patients 6 to 12 years of age [see Clinical Studies (14)]. Limitation of UseThe use of Methylphenidate hydrochloride extended-release capsules (LA) is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)].",
      "Description": "Methylphenidate hydrochloride extended-release capsules (LA) contains methylphenidate hydrochloride USP, a CNS stimulant. Methylphenidate hydrochloride extended-release capsules (LA) is an extended-release formulation of methylphenidate for oral administration with a bi-modal release profile. Each bead-filled methylphenidate hydrochloride extended-release capsule (LA) contains half the dose as immediate-release beads and half as enteric-coated beads, thus providing an immediate release of methylphenidate and a second delayed release of methylphenidate. The active substance in methylphenidate hydrochloride extended-release capsules (LA) is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is. Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Inactive ingredients: Sugar spheres (which contain sucrose and starch (corn)), hypromellose, cellulose acetate butyrate, hypromellose acetate succinate, acetyltributyl citrate, acetone, talc, and purified water. Opaque gelatin capsules contain: titanium dioxide and gelatin. The 10mg capsule contains FD&C Green#3, FD&C#40, and FD&C Yellow #6. The 30 and 40 mg capsules contain D&C Red #28 and FD&C Blue #1. The 60 mg capsules contain iron oxide yellow and sodium lauryl sulfate. The capsules are imprinted with black ink which contains black iron oxide, shellac and potassium hydroxide. The 60 mg black imprinting ink also contains ammonium hydroxide and propylene glycol."
    },
    {
      "NDCCode": "75907-051-01",
      "PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (75907-051-01) ",
      "NDC11Code": "75907-0051-01",
      "ProductNDC": "75907-051",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Methylphenidate Hydrochloride (la)",
      "NonProprietaryName": "Methylphenidate Hydrochloride",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20241220",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078458",
      "LabelerName": "Dr. Reddy's Laboratories Inc",
      "SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
      "StrengthNumber": "30",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
      "DEASchedule": "CII",
      "Status": "Active",
      "LastUpdate": "2025-10-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20241220",
      "SamplePackage": "N",
      "IndicationAndUsage": "Methylphenidate hydrochloride extended-release capsules (LA) is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), in pediatric patients 6 to 12 years of age [see Clinical Studies (14)]. Limitation of UseThe use of Methylphenidate hydrochloride extended-release capsules (LA) is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)].",
      "Description": "Methylphenidate hydrochloride extended-release capsules (LA) contains methylphenidate hydrochloride USP, a CNS stimulant. Methylphenidate hydrochloride extended-release capsules (LA) is an extended-release formulation of methylphenidate for oral administration with a bi-modal release profile. Each bead-filled methylphenidate hydrochloride extended-release capsule (LA) contains half the dose as immediate-release beads and half as enteric-coated beads, thus providing an immediate release of methylphenidate and a second delayed release of methylphenidate. The active substance in methylphenidate hydrochloride extended-release capsules (LA) is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is. Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Inactive ingredients: Sugar spheres (which contain sucrose and starch (corn)), hypromellose, cellulose acetate butyrate, hypromellose acetate succinate, acetyltributyl citrate, acetone, talc, and purified water. Opaque gelatin capsules contain: titanium dioxide and gelatin. The 10mg capsule contains FD&C Green#3, FD&C#40, and FD&C Yellow #6. The 30 and 40 mg capsules contain D&C Red #28 and FD&C Blue #1. The 60 mg capsules contain iron oxide yellow and sodium lauryl sulfate. The capsules are imprinted with black ink which contains black iron oxide, shellac and potassium hydroxide. The 60 mg black imprinting ink also contains ammonium hydroxide and propylene glycol."
    },
    {
      "NDCCode": "75907-052-01",
      "PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (75907-052-01) ",
      "NDC11Code": "75907-0052-01",
      "ProductNDC": "75907-052",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Methylphenidate Hydrochloride (la)",
      "NonProprietaryName": "Methylphenidate Hydrochloride",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20241220",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078458",
      "LabelerName": "Dr. Reddy's Laboratories Inc",
      "SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
      "DEASchedule": "CII",
      "Status": "Active",
      "LastUpdate": "2025-10-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20241220",
      "SamplePackage": "N",
      "IndicationAndUsage": "Methylphenidate hydrochloride extended-release capsules (LA) is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), in pediatric patients 6 to 12 years of age [see Clinical Studies (14)]. Limitation of UseThe use of Methylphenidate hydrochloride extended-release capsules (LA) is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)].",
      "Description": "Methylphenidate hydrochloride extended-release capsules (LA) contains methylphenidate hydrochloride USP, a CNS stimulant. Methylphenidate hydrochloride extended-release capsules (LA) is an extended-release formulation of methylphenidate for oral administration with a bi-modal release profile. Each bead-filled methylphenidate hydrochloride extended-release capsule (LA) contains half the dose as immediate-release beads and half as enteric-coated beads, thus providing an immediate release of methylphenidate and a second delayed release of methylphenidate. The active substance in methylphenidate hydrochloride extended-release capsules (LA) is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is. Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Inactive ingredients: Sugar spheres (which contain sucrose and starch (corn)), hypromellose, cellulose acetate butyrate, hypromellose acetate succinate, acetyltributyl citrate, acetone, talc, and purified water. Opaque gelatin capsules contain: titanium dioxide and gelatin. The 10mg capsule contains FD&C Green#3, FD&C#40, and FD&C Yellow #6. The 30 and 40 mg capsules contain D&C Red #28 and FD&C Blue #1. The 60 mg capsules contain iron oxide yellow and sodium lauryl sulfate. The capsules are imprinted with black ink which contains black iron oxide, shellac and potassium hydroxide. The 60 mg black imprinting ink also contains ammonium hydroxide and propylene glycol."
    },
    {
      "NDCCode": "75907-053-30",
      "PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (75907-053-30) ",
      "NDC11Code": "75907-0053-30",
      "ProductNDC": "75907-053",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Methylphenidate Hydrochloride (la)",
      "NonProprietaryName": "Methylphenidate Hydrochloride",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20241220",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078458",
      "LabelerName": "Dr. Reddy's Laboratories Inc",
      "SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
      "StrengthNumber": "60",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
      "DEASchedule": "CII",
      "Status": "Active",
      "LastUpdate": "2025-10-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20241220",
      "SamplePackage": "N",
      "IndicationAndUsage": "Methylphenidate hydrochloride extended-release capsules (LA) is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), in pediatric patients 6 to 12 years of age [see Clinical Studies (14)]. Limitation of UseThe use of Methylphenidate hydrochloride extended-release capsules (LA) is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)].",
      "Description": "Methylphenidate hydrochloride extended-release capsules (LA) contains methylphenidate hydrochloride USP, a CNS stimulant. Methylphenidate hydrochloride extended-release capsules (LA) is an extended-release formulation of methylphenidate for oral administration with a bi-modal release profile. Each bead-filled methylphenidate hydrochloride extended-release capsule (LA) contains half the dose as immediate-release beads and half as enteric-coated beads, thus providing an immediate release of methylphenidate and a second delayed release of methylphenidate. The active substance in methylphenidate hydrochloride extended-release capsules (LA) is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is. Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Inactive ingredients: Sugar spheres (which contain sucrose and starch (corn)), hypromellose, cellulose acetate butyrate, hypromellose acetate succinate, acetyltributyl citrate, acetone, talc, and purified water. Opaque gelatin capsules contain: titanium dioxide and gelatin. The 10mg capsule contains FD&C Green#3, FD&C#40, and FD&C Yellow #6. The 30 and 40 mg capsules contain D&C Red #28 and FD&C Blue #1. The 60 mg capsules contain iron oxide yellow and sodium lauryl sulfate. The capsules are imprinted with black ink which contains black iron oxide, shellac and potassium hydroxide. The 60 mg black imprinting ink also contains ammonium hydroxide and propylene glycol."
    },
    {
      "NDCCode": "75907-060-30",
      "PackageDescription": "30 g in 1 BOTTLE, PLASTIC (75907-060-30) ",
      "NDC11Code": "75907-0060-30",
      "ProductNDC": "75907-060",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Nystatin",
      "NonProprietaryName": "Nystatin",
      "DosageFormName": "POWDER",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240528",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065203",
      "LabelerName": "Dr. Reddy's Labratories Inc.",
      "SubstanceName": "NYSTATIN",
      "StrengthNumber": "100000",
      "StrengthUnit": "[USP'U]/g",
      "Pharm_Classes": "Polyene Antifungal [EPC], Polyenes [CS]",
      "Status": "Active",
      "LastUpdate": "2024-05-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240528",
      "SamplePackage": "N",
      "IndicationAndUsage": "Nystatin topical powder is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. Nystatin topical powder is not indicated for systemic, oral, intravaginal or ophthalmic use.",
      "Description": "Nystatin is a polyene antifungal antibiotic obtained from Streptomyces noursei. The molecular formula for Nystatin is C47H75NO17. The molecular weight of Nystatin is 926.1. Structural formula. Nystatin topical powder is for dermatologic use. Nystatin topical powder contains 100,000 USP nystatin units per gram dispersed in talc."
    },
    {
      "NDCCode": "75907-060-44",
      "PackageDescription": "15 g in 1 BOTTLE, PLASTIC (75907-060-44) ",
      "NDC11Code": "75907-0060-44",
      "ProductNDC": "75907-060",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Nystatin",
      "NonProprietaryName": "Nystatin",
      "DosageFormName": "POWDER",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240528",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065203",
      "LabelerName": "Dr. Reddy's Labratories Inc.",
      "SubstanceName": "NYSTATIN",
      "StrengthNumber": "100000",
      "StrengthUnit": "[USP'U]/g",
      "Pharm_Classes": "Polyene Antifungal [EPC], Polyenes [CS]",
      "Status": "Active",
      "LastUpdate": "2024-05-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240528",
      "SamplePackage": "N",
      "IndicationAndUsage": "Nystatin topical powder is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. Nystatin topical powder is not indicated for systemic, oral, intravaginal or ophthalmic use.",
      "Description": "Nystatin is a polyene antifungal antibiotic obtained from Streptomyces noursei. The molecular formula for Nystatin is C47H75NO17. The molecular weight of Nystatin is 926.1. Structural formula. Nystatin topical powder is for dermatologic use. Nystatin topical powder contains 100,000 USP nystatin units per gram dispersed in talc."
    },
    {
      "NDCCode": "75907-060-60",
      "PackageDescription": "60 g in 1 BOTTLE, PLASTIC (75907-060-60) ",
      "NDC11Code": "75907-0060-60",
      "ProductNDC": "75907-060",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Nystatin",
      "NonProprietaryName": "Nystatin",
      "DosageFormName": "POWDER",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240528",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065203",
      "LabelerName": "Dr. Reddy's Labratories Inc.",
      "SubstanceName": "NYSTATIN",
      "StrengthNumber": "100000",
      "StrengthUnit": "[USP'U]/g",
      "Pharm_Classes": "Polyene Antifungal [EPC], Polyenes [CS]",
      "Status": "Active",
      "LastUpdate": "2024-05-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240528",
      "SamplePackage": "N",
      "IndicationAndUsage": "Nystatin topical powder is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. Nystatin topical powder is not indicated for systemic, oral, intravaginal or ophthalmic use.",
      "Description": "Nystatin is a polyene antifungal antibiotic obtained from Streptomyces noursei. The molecular formula for Nystatin is C47H75NO17. The molecular weight of Nystatin is 926.1. Structural formula. Nystatin topical powder is for dermatologic use. Nystatin topical powder contains 100,000 USP nystatin units per gram dispersed in talc."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"75907-085-28","ProprietaryName":"Necon","NonProprietaryName":"Norethindrone And Ethinyl Estradiol"},{"NDCCode":"75907-085-32","ProprietaryName":"Necon","NonProprietaryName":"Norethindrone And Ethinyl Estradiol"},{"NDCCode":"59779-085-99","ProprietaryName":"Povidone Iodine","NonProprietaryName":"Povione Iodine"},{"NDCCode":"67046-085-28","ProprietaryName":"Clindamycin Hydrochloride","NonProprietaryName":"Clindamycin Hydrochloride"},{"NDCCode":"70108-085-01","ProprietaryName":"Smart Care Hot Wheels Hand Sanitizer","NonProprietaryName":"Ethyl Alcohol"},{"NDCCode":"70108-085-02","ProprietaryName":"Smart Care Hot Wheels Hand Sanitizer","NonProprietaryName":"Ethyl Alcohol"},{"NDCCode":"75907-074-32","ProprietaryName":"Camila","NonProprietaryName":"Norethindrone"},{"NDCCode":"75907-075-32","ProprietaryName":"Errin","NonProprietaryName":"Norethindrone"},{"NDCCode":"75907-078-55","ProprietaryName":"Low-ogestrel","NonProprietaryName":"Norgestrel And Ethinyl Estradiol"},{"NDCCode":"75907-079-55","ProprietaryName":"Lutera","NonProprietaryName":"Levonorgestrel And Ethinyl Estradiol"},{"NDCCode":"75907-081-28","ProprietaryName":"Microgestin Fe 1.5/30","NonProprietaryName":"Norethindrone Acetate/ethinyl Estradiol And Ferrous Fumarate"},{"NDCCode":"75907-082-28","ProprietaryName":"Microgestin Fe 1/20","NonProprietaryName":"Norethindrone Acetate/ethinyl Estradiol And Ferrous Fumarate"},{"NDCCode":"75907-086-28","ProprietaryName":"Tilia Fe","NonProprietaryName":"Ndac And Ee Tablets And Ferrous Fumarate Tablets"},{"NDCCode":"75907-087-28","ProprietaryName":"Zovia 1/35","NonProprietaryName":"Ethynodiol Diacetate And Ethinyl Estradiol Tablets"},{"NDCCode":"75907-089-55","ProprietaryName":"Sronyx","NonProprietaryName":"Levonorgestrel And Ethinyl Estradiol"},{"NDCCode":"75907-090-55","ProprietaryName":"Levora","NonProprietaryName":"Levonorgestrel And Ethinyl Estradiol"},{"NDCCode":"75907-091-28","ProprietaryName":"Azurette","NonProprietaryName":"Desogestrel/ethinyl Estradiol And Ethinyl Estradiol"},{"NDCCode":"75907-189-35","ProprietaryName":"Cyclophosphamide","NonProprietaryName":"Cyclophosphamide"},{"NDCCode":"75907-190-07","ProprietaryName":"Cyclophosphamide","NonProprietaryName":"Cyclophosphamide"},{"NDCCode":"75907-191-02","ProprietaryName":"Cyclophosphamide","NonProprietaryName":"Cyclophosphamide"},{"NDCCode":"75907-026-01","ProprietaryName":"Disopyramide Phosphate","NonProprietaryName":"Disopyramide Phosphate"},{"NDCCode":"75907-027-01","ProprietaryName":"Disopyramide Phosphate","NonProprietaryName":"Disopyramide Phosphate"},{"NDCCode":"75907-049-01","ProprietaryName":"Methylphenidate Hydrochloride (la)","NonProprietaryName":"Methylphenidate Hydrochloride"},{"NDCCode":"75907-050-01","ProprietaryName":"Methylphenidate Hydrochloride (la)","NonProprietaryName":"Methylphenidate Hydrochloride"},{"NDCCode":"75907-051-01","ProprietaryName":"Methylphenidate Hydrochloride (la)","NonProprietaryName":"Methylphenidate Hydrochloride"},{"NDCCode":"75907-052-01","ProprietaryName":"Methylphenidate Hydrochloride (la)","NonProprietaryName":"Methylphenidate Hydrochloride"},{"NDCCode":"75907-053-30","ProprietaryName":"Methylphenidate Hydrochloride (la)","NonProprietaryName":"Methylphenidate Hydrochloride"},{"NDCCode":"75907-060-30","ProprietaryName":"Nystatin","NonProprietaryName":"Nystatin"},{"NDCCode":"75907-060-44","ProprietaryName":"Nystatin","NonProprietaryName":"Nystatin"},{"NDCCode":"75907-060-60","ProprietaryName":"Nystatin","NonProprietaryName":"Nystatin"}]}
                    

<NDCList><NDC><NDCCode>75907-085-28</NDCCode><ProprietaryName>Necon</ProprietaryName><NonProprietaryName>Norethindrone And Ethinyl Estradiol</NonProprietaryName></NDC><NDC><NDCCode>75907-085-32</NDCCode><ProprietaryName>Necon</ProprietaryName><NonProprietaryName>Norethindrone And Ethinyl Estradiol</NonProprietaryName></NDC><NDC><NDCCode>59779-085-99</NDCCode><ProprietaryName>Povidone Iodine</ProprietaryName><NonProprietaryName>Povione Iodine</NonProprietaryName></NDC><NDC><NDCCode>67046-085-28</NDCCode><ProprietaryName>Clindamycin Hydrochloride</ProprietaryName><NonProprietaryName>Clindamycin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>70108-085-01</NDCCode><ProprietaryName>Smart Care Hot Wheels Hand Sanitizer</ProprietaryName><NonProprietaryName>Ethyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>70108-085-02</NDCCode><ProprietaryName>Smart Care Hot Wheels Hand Sanitizer</ProprietaryName><NonProprietaryName>Ethyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>75907-074-32</NDCCode><ProprietaryName>Camila</ProprietaryName><NonProprietaryName>Norethindrone</NonProprietaryName></NDC><NDC><NDCCode>75907-075-32</NDCCode><ProprietaryName>Errin</ProprietaryName><NonProprietaryName>Norethindrone</NonProprietaryName></NDC><NDC><NDCCode>75907-078-55</NDCCode><ProprietaryName>Low-ogestrel</ProprietaryName><NonProprietaryName>Norgestrel And Ethinyl Estradiol</NonProprietaryName></NDC><NDC><NDCCode>75907-079-55</NDCCode><ProprietaryName>Lutera</ProprietaryName><NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName></NDC><NDC><NDCCode>75907-081-28</NDCCode><ProprietaryName>Microgestin Fe 1.5/30</ProprietaryName><NonProprietaryName>Norethindrone Acetate/ethinyl Estradiol And Ferrous Fumarate</NonProprietaryName></NDC><NDC><NDCCode>75907-082-28</NDCCode><ProprietaryName>Microgestin Fe 1/20</ProprietaryName><NonProprietaryName>Norethindrone Acetate/ethinyl Estradiol And Ferrous Fumarate</NonProprietaryName></NDC><NDC><NDCCode>75907-086-28</NDCCode><ProprietaryName>Tilia Fe</ProprietaryName><NonProprietaryName>Ndac And Ee Tablets And Ferrous Fumarate Tablets</NonProprietaryName></NDC><NDC><NDCCode>75907-087-28</NDCCode><ProprietaryName>Zovia 1/35</ProprietaryName><NonProprietaryName>Ethynodiol Diacetate And Ethinyl Estradiol Tablets</NonProprietaryName></NDC><NDC><NDCCode>75907-089-55</NDCCode><ProprietaryName>Sronyx</ProprietaryName><NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName></NDC><NDC><NDCCode>75907-090-55</NDCCode><ProprietaryName>Levora</ProprietaryName><NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName></NDC><NDC><NDCCode>75907-091-28</NDCCode><ProprietaryName>Azurette</ProprietaryName><NonProprietaryName>Desogestrel/ethinyl Estradiol And Ethinyl Estradiol</NonProprietaryName></NDC><NDC><NDCCode>75907-189-35</NDCCode><ProprietaryName>Cyclophosphamide</ProprietaryName><NonProprietaryName>Cyclophosphamide</NonProprietaryName></NDC><NDC><NDCCode>75907-190-07</NDCCode><ProprietaryName>Cyclophosphamide</ProprietaryName><NonProprietaryName>Cyclophosphamide</NonProprietaryName></NDC><NDC><NDCCode>75907-191-02</NDCCode><ProprietaryName>Cyclophosphamide</ProprietaryName><NonProprietaryName>Cyclophosphamide</NonProprietaryName></NDC><NDC><NDCCode>75907-026-01</NDCCode><ProprietaryName>Disopyramide Phosphate</ProprietaryName><NonProprietaryName>Disopyramide Phosphate</NonProprietaryName></NDC><NDC><NDCCode>75907-027-01</NDCCode><ProprietaryName>Disopyramide Phosphate</ProprietaryName><NonProprietaryName>Disopyramide Phosphate</NonProprietaryName></NDC><NDC><NDCCode>75907-049-01</NDCCode><ProprietaryName>Methylphenidate Hydrochloride (la)</ProprietaryName><NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>75907-050-01</NDCCode><ProprietaryName>Methylphenidate Hydrochloride (la)</ProprietaryName><NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>75907-051-01</NDCCode><ProprietaryName>Methylphenidate Hydrochloride (la)</ProprietaryName><NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>75907-052-01</NDCCode><ProprietaryName>Methylphenidate Hydrochloride (la)</ProprietaryName><NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>75907-053-30</NDCCode><ProprietaryName>Methylphenidate Hydrochloride (la)</ProprietaryName><NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>75907-060-30</NDCCode><ProprietaryName>Nystatin</ProprietaryName><NonProprietaryName>Nystatin</NonProprietaryName></NDC><NDC><NDCCode>75907-060-44</NDCCode><ProprietaryName>Nystatin</ProprietaryName><NonProprietaryName>Nystatin</NonProprietaryName></NDC><NDC><NDCCode>75907-060-60</NDCCode><ProprietaryName>Nystatin</ProprietaryName><NonProprietaryName>Nystatin</NonProprietaryName></NDC></NDCList>