{
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"SubstanceName": "ACETAMINOPHEN; IBUPROFEN",
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"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
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"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to:. headache . toothache. backache . menstrual cramps. muscular aches . minor pain of arthritis."
},
{
"NDCCode": "51486-720-23",
"PackageDescription": "690 L in 1 CYLINDER (51486-720-23) ",
"NDC11Code": "51486-0720-23",
"ProductNDC": "51486-720",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen",
"NonProprietaryName": "Oxygen",
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"RouteName": "RESPIRATORY (INHALATION)",
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"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205865",
"LabelerName": "ILMO Products Company",
"SubstanceName": "OXYGEN",
"StrengthNumber": "990",
"StrengthUnit": "mL/L",
"Status": "Active",
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"ProductNdcExcludeFlag": "N",
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},
{
"NDCCode": "51887-720-23",
"PackageDescription": "403 L in 1 DEWAR (51887-720-23) ",
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"ProductNDC": "51887-720",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen",
"NonProprietaryName": "Oxygen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19890101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205767",
"LabelerName": "Maine Oxy-Acetylene Supply Company",
"SubstanceName": "OXYGEN",
"StrengthNumber": "990",
"StrengthUnit": "mL/L",
"Status": "Active",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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},
{
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"ProductNDC": "30142-094",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nasal Decongestant Pe",
"ProprietaryNameSuffix": "Non Drowsy Maximum Strength",
"NonProprietaryName": "Phenylephrine Hydrochloride",
"DosageFormName": "TABLET",
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"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Kroger Company",
"SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-12-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20050812",
"SamplePackage": "N"
},
{
"NDCCode": "30142-205-23",
"PackageDescription": "251 mL in 1 BOTTLE, PLASTIC (30142-205-23) ",
"NDC11Code": "30142-0205-23",
"ProductNDC": "30142-205",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Therapeutic T Plus",
"NonProprietaryName": "Coal Tar",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110331",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M032",
"LabelerName": "The Kroger Co",
"SubstanceName": "COAL TAR",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20110331",
"SamplePackage": "N",
"IndicationAndUsage": "controls the symptoms of: 1 dandruff, 2 seborrheic dermatitis, 3 psoriasis."
},
{
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"PackageDescription": "36 POUCH in 1 CARTON (30142-421-23) > 2 TABLET, EFFERVESCENT in 1 POUCH",
"NDC11Code": "30142-0421-23",
"ProductNDC": "30142-421",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kroger Effervescent Antacid And Pain Relief",
"NonProprietaryName": "Aspirin, Citric Acid, Sodium Bicarbonate",
"DosageFormName": "TABLET, EFFERVESCENT",
"RouteName": "ORAL",
"StartMarketingDate": "20150113",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part343",
"LabelerName": "Kroger Company",
"SubstanceName": "ANHYDROUS CITRIC ACID; ASPIRIN; SODIUM BICARBONATE",
"StrengthNumber": "1000; 325; 1916",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Acidifying Activity [MoA], Alkalinizing Activity [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Cyclooxygenase Inhibitors [MoA], Decreased Coagulation Factor Activity [PE], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20150114",
"EndMarketingDatePackage": "20221231",
"SamplePackage": "N",
"IndicationAndUsage": "Usesfor the temporary relief of. ■ heartburn, acid indigestion and sour stomach when accompanied by headache or body aches and pains. ■ upset stomach with headache from overindulgence in food or drink. ■ pain alone (headaches or body aches and pains)."
},
{
"NDCCode": "30142-853-23",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (30142-853-23) / 24 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "30142-0853-23",
"ProductNDC": "30142-853",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sinus Congestion",
"NonProprietaryName": "Phenylephrine Hcl",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210319",
"EndMarketingDate": "20290131",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Kroger Company",
"SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210319",
"EndMarketingDatePackage": "20290131",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves sinus congestion and pressure. temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies."
},
{
"NDCCode": "30142-922-23",
"PackageDescription": "113 g in 1 BOTTLE, PLASTIC (30142-922-23)",
"NDC11Code": "30142-0922-23",
"ProductNDC": "30142-922",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kroger Sheer Dry Touch Sunscreen",
"ProprietaryNameSuffix": "Spf 55",
"NonProprietaryName": "Avobenzone Homosalate Octisalate Octocrylene Oxybenzone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130917",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "THE KROGER CO",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "3; 10; 5; 2.8; 6",
"StrengthUnit": "g/100g; g/100g; g/100g; g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "30142-924-23",
"PackageDescription": "113 g in 1 BOTTLE, PLASTIC (30142-924-23)",
"NDC11Code": "30142-0924-23",
"ProductNDC": "30142-924",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kroger Sheer Dry Touch Sunscreen",
"ProprietaryNameSuffix": "Spf 70",
"NonProprietaryName": "Avobenzone Homosalate Octisalate Octocrylene Oxybenzone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130919",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "THE KROGER CO",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "3; 15; 5; 2.8; 6",
"StrengthUnit": "g/100g; g/100g; g/100g; g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "30142-953-23",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (30142-953-23) > 24 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "30142-0953-23",
"ProductNDC": "30142-953",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nasal Decongestant",
"NonProprietaryName": "Phenylephrine Hcl",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190603",
"EndMarketingDate": "20230709",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Kroger Company",
"SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-07-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190603",
"EndMarketingDatePackage": "20230709",
"SamplePackage": "N"
},
{
"NDCCode": "30142-998-23",
"PackageDescription": "1 BOTTLE in 1 CARTON (30142-998-23) > 72 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "30142-0998-23",
"ProductNDC": "30142-998",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti Diarrheal",
"NonProprietaryName": "Loperamide Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20030221",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075232",
"LabelerName": "Kroger Company",
"SubstanceName": "LOPERAMIDE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20140225",
"SamplePackage": "N"
},
{
"NDCCode": "12213-720-12",
"PackageDescription": "7051 L in 1 CYLINDER (12213-720-12) ",
"NDC11Code": "12213-0720-12",
"ProductNDC": "12213-720",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen",
"NonProprietaryName": "Oxygen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19960601",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205849",
"LabelerName": "NexAir, LLC",
"SubstanceName": "OXYGEN",
"StrengthNumber": "991",
"StrengthUnit": "mL/L",
"Status": "Deprecated",
"LastUpdate": "2022-02-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "19960601",
"SamplePackage": "N"
},
{
"NDCCode": "12213-720-15",
"PackageDescription": "1133 L in 1 CYLINDER (12213-720-15) ",
"NDC11Code": "12213-0720-15",
"ProductNDC": "12213-720",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen",
"NonProprietaryName": "Oxygen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19960601",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205849",
"LabelerName": "NexAir, LLC",
"SubstanceName": "OXYGEN",
"StrengthNumber": "991",
"StrengthUnit": "mL/L",
"Status": "Deprecated",
"LastUpdate": "2022-02-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "19960601",
"SamplePackage": "N"
},
{
"NDCCode": "12213-720-45",
"PackageDescription": "41 L in 1 CYLINDER (12213-720-45) ",
"NDC11Code": "12213-0720-45",
"ProductNDC": "12213-720",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen",
"NonProprietaryName": "Oxygen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19960601",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205849",
"LabelerName": "NexAir, LLC",
"SubstanceName": "OXYGEN",
"StrengthNumber": "991",
"StrengthUnit": "mL/L",
"Status": "Deprecated",
"LastUpdate": "2022-02-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "19960601",
"SamplePackage": "N"
},
{
"NDCCode": "12213-720-50",
"PackageDescription": "2350 L in 1 CYLINDER (12213-720-50) ",
"NDC11Code": "12213-0720-50",
"ProductNDC": "12213-720",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen",
"NonProprietaryName": "Oxygen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19960601",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205849",
"LabelerName": "NexAir, LLC",
"SubstanceName": "OXYGEN",
"StrengthNumber": "991",
"StrengthUnit": "mL/L",
"Status": "Deprecated",
"LastUpdate": "2022-02-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "19960601",
"SamplePackage": "N"
},
{
"NDCCode": "12213-720-58",
"PackageDescription": "663 L in 1 CYLINDER (12213-720-58) ",
"NDC11Code": "12213-0720-58",
"ProductNDC": "12213-720",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen",
"NonProprietaryName": "Oxygen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19960601",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205849",
"LabelerName": "NexAir, LLC",
"SubstanceName": "OXYGEN",
"StrengthNumber": "991",
"StrengthUnit": "mL/L",
"Status": "Deprecated",
"LastUpdate": "2022-02-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "19960601",
"SamplePackage": "N"
},
{
"NDCCode": "46602-0102-5",
"PackageDescription": "100 SYRINGE, GLASS in 1 BOX (46602-0102-5) / 2.4 mL in 1 SYRINGE, GLASS",
"NDC11Code": "46602-0102-05",
"ProductNDC": "46602-0102",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "INJECTION, SUSPENSION, EXTENDED RELEASE",
"StartMarketingDate": "20230510",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "OTSUKA PHARMACEUTICAL CO., LTD.",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "720",
"StrengthUnit": "mg/2.4mL",
"Status": "Unfinished",
"LastUpdate": "2023-05-15",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "10-MAY-23"
},
{
"NDCCode": "50102-220-23",
"PackageDescription": "3 POUCH in 1 CARTON (50102-220-23) / 1 BLISTER PACK in 1 POUCH (50102-220-21) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "50102-0220-23",
"ProductNDC": "50102-220",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aubra Eq",
"NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20161114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206886",
"LabelerName": "Afaxys Pharma, LLC",
"Status": "Active",
"LastUpdate": "2025-08-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20161114",
"SamplePackage": "N",
"IndicationAndUsage": "Aubra EQ 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. Emergency Contraceptive Pills: The FDA has concluded that certain combined oral contraceptives containing ethinyl estradiol and norgestrel or levonorgestrel are safe and effective for use as postcoital emergency contraception. Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9. Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraception.10. Source: Trussell J. Contraceptive efficacy. In: Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowel D, Guest F. Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers; 1998. 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. 9. The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following dosage regimens of oral contraceptives to be safe and effective for emergency contraception: for tablets containing 50 mcg of ethinyl estradiol and 500 mcg of norgestrel 1 dose is 2 tablets; for tablets containing 20 mcg of ethinyl estradiol and 100 mcg of levonorgestrel 1 dose is 5 tablets; for tablets containing 30 mcg of ethinyl estradiol and 150 mcg of levonorgestrel 1 dose is 4 tablets. 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. 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 USP, d(-)-13β-ethyl-17α- ethinyl-17β-hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol USP, 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, green tablet (7) contains the following inactive ingredients: croscarmellose sodium, FD & C Blue No. 2 Aluminum Lake, ferric oxide (sicovit yellow 10), lactose anhydrous, magnesium stearate, microcrystalline cellulose, and povidone."
},
{
"NDCCode": "51114-0924-5",
"PackageDescription": "25 kg in 1 DRUM (51114-0924-5) ",
"NDC11Code": "51114-0924-05",
"ProductNDC": "51114-0924",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Pyrantel Pamoate",
"DosageFormName": "GRANULE",
"StartMarketingDate": "20240923",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Vovantis Laboratories Private Limited",
"SubstanceName": "PYRANTEL PAMOATE",
"StrengthNumber": "720.5",
"StrengthUnit": "mg/.0015kg",
"Status": "Unfinished",
"LastUpdate": "2026-01-14",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "23-SEP-24"
},
{
"NDCCode": "55118-978-01",
"PackageDescription": "1 KIT in 1 CARTON (55118-978-01) * 14 mL in 1 CUP, UNIT-DOSE * 10 g in 1 TUBE * 10 CUP, UNIT-DOSE in 1 TRAY (50383-720-15) > 15 mL in 1 CUP, UNIT-DOSE * 14 mL in 1 CUP, UNIT-DOSE (55118-991-01)",
"NDC11Code": "55118-0978-01",
"ProductNDC": "55118-978",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kimvent",
"ProprietaryNameSuffix": "Oral Care Q2 Kit With Chg",
"NonProprietaryName": "Hydrogen Peroxide And Chlorhexidine Gluconate",
"DosageFormName": "KIT",
"StartMarketingDate": "19960507",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074356",
"LabelerName": "Halyard Health",
"Status": "Deprecated",
"LastUpdate": "2019-10-23",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "57841-1200-1",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (57841-1200-1) / 6 TABLET, DELAYED RELEASE in 1 BLISTER PACK (57841-1200-0) ",
"NDC11Code": "57841-1200-01",
"ProductNDC": "57841-1200",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aemcolo",
"NonProprietaryName": "Rifamycin",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20210701",
"EndMarketingDate": "20250430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210910",
"LabelerName": "RedHill Biopharma Ltd",
"SubstanceName": "RIFAMYCIN",
"StrengthNumber": "194",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Rifamycin Antibacterial [EPC], Rifamycins [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210701",
"EndMarketingDatePackage": "20250430",
"SamplePackage": "N",
"IndicationAndUsage": "AEMCOLO is a rifamycin antibacterial indicated for the treatment of travelers' diarrhea caused by noninvasive strains of Escherichia coliin adults. ( 1.1). Limitations of Use:. AEMCOLO is not recommended for use in patients with diarrhea complicated by fever and/or bloody stool or due to pathogens other than noninvasive strains of E. coli.( 1, 5.1, 14). To reduce the development of drug-resistant bacteria and maintain the effectiveness of AEMCOLO and other antibacterial drugs, AEMCOLO should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria ( 1.2).",
"Description": "AEMCOLO, delayed-release tablet, for oral administration, contains 194 mg of rifamycin equivalent to 200 mg of rifamycin sodium. Rifamycin sodium is a rifamycin antibacterial. It is designated chemically as: Sodium (2S,12Z,14E,16S,17S,18R,19R,20R,21S,22R,23S,24E)-21-(acetyloxy)-6,9,17,19-tetrahydroxy-23-methoxy-2,4,12,16,18,20,22-heptamethyl-1,11-dioxo-1,2-dihydro-2,7-(epoxypentadeca[1,11,13]trienimino)naphtho[2,1- b]furan-5-olate. Its empirical formula is C 37H 46NNaO 12. The molecular weight is 720 g/mol. Its structural formula is. Rifamycin sodium is a fine or slightly granular powder, soluble in water, and freely soluble in anhydrous ethanol. AEMCOLO, delayed-release tablets are enteric coated with a pH-resistant polymer film which breaks down above pH 7. The tablet core contains rifamycin. The tablets are yellow brown and ellipsoidal. Each tablet contains the following inactive ingredients: ammonio methacrylate copolymer (Type B), ascorbic acid, glyceryl distearate, lecithin, magnesium stearate, mannitol, methacrylic acid and methyl methacrylate copolymer (1:2), polyethylene glycol 6000, colloidal silicon dioxide, talc, titanium dioxide, triethylcitrate, yellow ferric oxide."
},
{
"NDCCode": "57841-1200-2",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (57841-1200-2) / 6 TABLET, DELAYED RELEASE in 1 BLISTER PACK (57841-1200-0) ",
"NDC11Code": "57841-1200-02",
"ProductNDC": "57841-1200",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aemcolo",
"NonProprietaryName": "Rifamycin",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20210701",
"EndMarketingDate": "20250430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210910",
"LabelerName": "RedHill Biopharma Ltd",
"SubstanceName": "RIFAMYCIN",
"StrengthNumber": "194",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Rifamycin Antibacterial [EPC], Rifamycins [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210701",
"EndMarketingDatePackage": "20250430",
"SamplePackage": "N",
"IndicationAndUsage": "AEMCOLO is a rifamycin antibacterial indicated for the treatment of travelers' diarrhea caused by noninvasive strains of Escherichia coliin adults. ( 1.1). Limitations of Use:. AEMCOLO is not recommended for use in patients with diarrhea complicated by fever and/or bloody stool or due to pathogens other than noninvasive strains of E. coli.( 1, 5.1, 14). To reduce the development of drug-resistant bacteria and maintain the effectiveness of AEMCOLO and other antibacterial drugs, AEMCOLO should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria ( 1.2).",
"Description": "AEMCOLO, delayed-release tablet, for oral administration, contains 194 mg of rifamycin equivalent to 200 mg of rifamycin sodium. Rifamycin sodium is a rifamycin antibacterial. It is designated chemically as: Sodium (2S,12Z,14E,16S,17S,18R,19R,20R,21S,22R,23S,24E)-21-(acetyloxy)-6,9,17,19-tetrahydroxy-23-methoxy-2,4,12,16,18,20,22-heptamethyl-1,11-dioxo-1,2-dihydro-2,7-(epoxypentadeca[1,11,13]trienimino)naphtho[2,1- b]furan-5-olate. Its empirical formula is C 37H 46NNaO 12. The molecular weight is 720 g/mol. Its structural formula is. Rifamycin sodium is a fine or slightly granular powder, soluble in water, and freely soluble in anhydrous ethanol. AEMCOLO, delayed-release tablets are enteric coated with a pH-resistant polymer film which breaks down above pH 7. The tablet core contains rifamycin. The tablets are yellow brown and ellipsoidal. Each tablet contains the following inactive ingredients: ammonio methacrylate copolymer (Type B), ascorbic acid, glyceryl distearate, lecithin, magnesium stearate, mannitol, methacrylic acid and methyl methacrylate copolymer (1:2), polyethylene glycol 6000, colloidal silicon dioxide, talc, titanium dioxide, triethylcitrate, yellow ferric oxide."
},
{
"NDCCode": "57841-1201-1",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (57841-1201-1) / 4 TABLET, DELAYED RELEASE in 1 BLISTER PACK (57841-1201-0) ",
"NDC11Code": "57841-1201-01",
"ProductNDC": "57841-1201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aemcolo",
"NonProprietaryName": "Rifamycin",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20210701",
"EndMarketingDate": "20250430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210910",
"LabelerName": "RedHill Biopharma Ltd",
"SubstanceName": "RIFAMYCIN",
"StrengthNumber": "194",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Rifamycin Antibacterial [EPC], Rifamycins [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210701",
"EndMarketingDatePackage": "20250430",
"SamplePackage": "N",
"IndicationAndUsage": "AEMCOLO is a rifamycin antibacterial indicated for the treatment of travelers' diarrhea caused by noninvasive strains of Escherichia coliin adults. ( 1.1). Limitations of Use:. AEMCOLO is not recommended for use in patients with diarrhea complicated by fever and/or bloody stool or due to pathogens other than noninvasive strains of E. coli.( 1, 5.1, 14). To reduce the development of drug-resistant bacteria and maintain the effectiveness of AEMCOLO and other antibacterial drugs, AEMCOLO should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria ( 1.2).",
"Description": "AEMCOLO, delayed-release tablet, for oral administration, contains 194 mg of rifamycin equivalent to 200 mg of rifamycin sodium. Rifamycin sodium is a rifamycin antibacterial. It is designated chemically as: Sodium (2S,12Z,14E,16S,17S,18R,19R,20R,21S,22R,23S,24E)-21-(acetyloxy)-6,9,17,19-tetrahydroxy-23-methoxy-2,4,12,16,18,20,22-heptamethyl-1,11-dioxo-1,2-dihydro-2,7-(epoxypentadeca[1,11,13]trienimino)naphtho[2,1- b]furan-5-olate. Its empirical formula is C 37H 46NNaO 12. The molecular weight is 720 g/mol. Its structural formula is. Rifamycin sodium is a fine or slightly granular powder, soluble in water, and freely soluble in anhydrous ethanol. AEMCOLO, delayed-release tablets are enteric coated with a pH-resistant polymer film which breaks down above pH 7. The tablet core contains rifamycin. The tablets are yellow brown and ellipsoidal. Each tablet contains the following inactive ingredients: ammonio methacrylate copolymer (Type B), ascorbic acid, glyceryl distearate, lecithin, magnesium stearate, mannitol, methacrylic acid and methyl methacrylate copolymer (1:2), polyethylene glycol 6000, colloidal silicon dioxide, talc, titanium dioxide, triethylcitrate, yellow ferric oxide."
},
{
"NDCCode": "59651-720-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (59651-720-01) ",
"NDC11Code": "59651-0720-01",
"ProductNDC": "59651-720",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dicyclomine Hydrochloride",
"NonProprietaryName": "Dicyclomine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230425",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040317",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "DICYCLOMINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2023-05-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230425",
"SamplePackage": "N",
"IndicationAndUsage": "Dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/ irritable bowel syndrome.",
"Description": "Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent. Chemically, dicyclomine hydrochloride is [bicyclohexyl]-1-carboxylic acid, 2-(diethylamino) ethyl ester, hydrochloride with the following structural formula, molecular weight, and molecular formula:. Dicyclomine hydrochloride, USP occurs as a white crystalline powder. It is soluble in water, freely soluble in alcohol and chloroform, and very slightly soluble in ether. Dicyclomine hydrochloride tablets, USP for oral administration contain 20 mg of dicyclomine hydrochloride, USP. In addition each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, FD&C Blue No. 1 Aluminum Lake, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate."
},
{
"NDCCode": "59651-720-99",
"PackageDescription": "1000 TABLET in 1 BOTTLE (59651-720-99) ",
"NDC11Code": "59651-0720-99",
"ProductNDC": "59651-720",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dicyclomine Hydrochloride",
"NonProprietaryName": "Dicyclomine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230425",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040317",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "DICYCLOMINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2023-05-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230425",
"SamplePackage": "N",
"IndicationAndUsage": "Dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/ irritable bowel syndrome.",
"Description": "Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent. Chemically, dicyclomine hydrochloride is [bicyclohexyl]-1-carboxylic acid, 2-(diethylamino) ethyl ester, hydrochloride with the following structural formula, molecular weight, and molecular formula:. Dicyclomine hydrochloride, USP occurs as a white crystalline powder. It is soluble in water, freely soluble in alcohol and chloroform, and very slightly soluble in ether. Dicyclomine hydrochloride tablets, USP for oral administration contain 20 mg of dicyclomine hydrochloride, USP. In addition each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, FD&C Blue No. 1 Aluminum Lake, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate."
},
{
"NDCCode": "60274-720-01",
"PackageDescription": "96000 CAPSULE, EXTENDED RELEASE in 1 DRUM (60274-720-01) ",
"NDC11Code": "60274-0720-01",
"ProductNDC": "60274-720",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Dexmethylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"StartMarketingDate": "20050531",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Societal CDMO Gainesville, LLC",
"SubstanceName": "DEXMETHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"DEASchedule": "CII",
"Status": "Unfinished",
"LastUpdate": "2022-11-23",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "31-MAY-05"
},
{
"NDCCode": "63304-720-05",
"PackageDescription": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63304-720-05) ",
"NDC11Code": "63304-0720-05",
"ProductNDC": "63304-720",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20181031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203023",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "240",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181031",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules, USP are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules, USP are indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1, 5-Benzothiazepin-4(5 H)-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)- cis-. The chemical structure is:. Diltiazem hydrochloride, USP is a white, odorless crystalline powder or small crystals. It is freely soluble in chloroform, formic acid, methanol, and water. It is sparingly soluble in dehydrated alcohol and is insoluble in ether. It has a molecular weight of 450.98. Diltiazem hydrochloride is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride, USP (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride, USP (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride, USP (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride, USP (equivalent to 330.9 mg diltiazem). The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsules also contain: acetyl tributyl citrate, ammonio methacrylate copolymer dispersion, hypromellose, sodium lauryl sulfate, sugar spheres (sucrose and corn starch), and talc. The 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg capsule shells contain FD&C Blue #1, gelatin, sodium lauryl sulfate, and titanium dioxide. The 180 mg, 240 mg, 300 mg, and 360 mg capsule shells also contain iron oxide black. The 120 mg, 180 mg, 300 mg, and 360 mg capsules are imprinted with black ink which contains iron oxide black, potassium hydroxide, propylene glycol, and shellac. The 240 mg capsules are imprinted with white ink which contains potassium hydroxide, propylene glycol, shellac, and titanium dioxide. For oral administration. Meets USP dissolution test 29."
},
{
"NDCCode": "63304-720-30",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63304-720-30) ",
"NDC11Code": "63304-0720-30",
"ProductNDC": "63304-720",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20181031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203023",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "240",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181031",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules, USP are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules, USP are indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1, 5-Benzothiazepin-4(5 H)-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)- cis-. The chemical structure is:. Diltiazem hydrochloride, USP is a white, odorless crystalline powder or small crystals. It is freely soluble in chloroform, formic acid, methanol, and water. It is sparingly soluble in dehydrated alcohol and is insoluble in ether. It has a molecular weight of 450.98. Diltiazem hydrochloride is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride, USP (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride, USP (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride, USP (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride, USP (equivalent to 330.9 mg diltiazem). The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsules also contain: acetyl tributyl citrate, ammonio methacrylate copolymer dispersion, hypromellose, sodium lauryl sulfate, sugar spheres (sucrose and corn starch), and talc. The 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg capsule shells contain FD&C Blue #1, gelatin, sodium lauryl sulfate, and titanium dioxide. The 180 mg, 240 mg, 300 mg, and 360 mg capsule shells also contain iron oxide black. The 120 mg, 180 mg, 300 mg, and 360 mg capsules are imprinted with black ink which contains iron oxide black, potassium hydroxide, propylene glycol, and shellac. The 240 mg capsules are imprinted with white ink which contains potassium hydroxide, propylene glycol, shellac, and titanium dioxide. For oral administration. Meets USP dissolution test 29."
},
{
"NDCCode": "63304-720-90",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63304-720-90) ",
"NDC11Code": "63304-0720-90",
"ProductNDC": "63304-720",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20181031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203023",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "240",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181031",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules, USP are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules, USP are indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1, 5-Benzothiazepin-4(5 H)-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)- cis-. The chemical structure is:. Diltiazem hydrochloride, USP is a white, odorless crystalline powder or small crystals. It is freely soluble in chloroform, formic acid, methanol, and water. It is sparingly soluble in dehydrated alcohol and is insoluble in ether. It has a molecular weight of 450.98. Diltiazem hydrochloride is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride, USP (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride, USP (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride, USP (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride, USP (equivalent to 330.9 mg diltiazem). The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsules also contain: acetyl tributyl citrate, ammonio methacrylate copolymer dispersion, hypromellose, sodium lauryl sulfate, sugar spheres (sucrose and corn starch), and talc. The 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg capsule shells contain FD&C Blue #1, gelatin, sodium lauryl sulfate, and titanium dioxide. The 180 mg, 240 mg, 300 mg, and 360 mg capsule shells also contain iron oxide black. The 120 mg, 180 mg, 300 mg, and 360 mg capsules are imprinted with black ink which contains iron oxide black, potassium hydroxide, propylene glycol, and shellac. The 240 mg capsules are imprinted with white ink which contains potassium hydroxide, propylene glycol, shellac, and titanium dioxide. For oral administration. Meets USP dissolution test 29."
},
{
"NDCCode": "67877-720-31",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (67877-720-31) / 10 TABLET in 1 BLISTER PACK (67877-720-33) ",
"NDC11Code": "67877-0720-31",
"ProductNDC": "67877-720",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Everolimus",
"NonProprietaryName": "Everolimus",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20211127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214138",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "EVEROLIMUS",
"StrengthNumber": ".75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211127",
"SamplePackage": "N",
"IndicationAndUsage": "Everolimus tablets are a mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients: Kidney Transplant: at low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids (1.1) Liver Transplant: Administer no earlier than 30 days posttransplant. Use in combination with tacrolimus (reduced doses) and corticosteroids (1.2, 5.5). Limitations of Use: Safety and efficacy have not been established in the following: Kidney transplant patients at high immunologic risk (1.3) Recipients of transplanted organs other than kidney or liver (1.3, 5.7) Pediatric patients (less than 18 years) (1.3).",
"Description": "Everolimus is a macrolide immunosuppressant. The chemical name of everolimus is (1R, 9S, 12S, 15R, 16E, 18R, 19R, 21R, 23S, 24E, 26E, 28E, 30S, 32S, 35R)-1, 18-dihydroxy-12 -{(1R)-2-[(1S,3R,4R) 4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15, 17, 21, 23, 29, 35-hexamethyl-11, 36 dioxa-4-aza-tricyclo[30.3.1.04,9] hexatriaconta-16,24,26,28-tetraene-2, 3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.25. The structural formula is. Everolimus is supplied as tablets for oral administration containing 0.25 mg, 0.5 mg, 0.75 mg and 1 mg of everolimus together with butylated hydroxytoluene, crospovidone type A, hypromellose, lactose anhydrous, lactose monohydrate and magnesium stearate as inactive ingredients."
}
]
}
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<NDCList>
<NDC>
<NDCCode>30142-720-23</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (30142-720-23) / 72 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>30142-0720-23</NDC11Code>
<ProductNDC>30142-720</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen And Ibuprofen</ProprietaryName>
<NonProprietaryName>Acetaminophen, Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230516</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214836</ApplicationNumber>
<LabelerName>Kroger Company</LabelerName>
<SubstanceName>ACETAMINOPHEN; IBUPROFEN</SubstanceName>
<StrengthNumber>250; 125</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230516</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to:. headache . toothache. backache . menstrual cramps. muscular aches . minor pain of arthritis.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>51486-720-23</NDCCode>
<PackageDescription>690 L in 1 CYLINDER (51486-720-23) </PackageDescription>
<NDC11Code>51486-0720-23</NDC11Code>
<ProductNDC>51486-720</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxygen</ProprietaryName>
<NonProprietaryName>Oxygen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19900101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205865</ApplicationNumber>
<LabelerName>ILMO Products Company</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>990</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19900101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>51887-720-23</NDCCode>
<PackageDescription>403 L in 1 DEWAR (51887-720-23) </PackageDescription>
<NDC11Code>51887-0720-23</NDC11Code>
<ProductNDC>51887-720</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxygen</ProprietaryName>
<NonProprietaryName>Oxygen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19890101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205767</ApplicationNumber>
<LabelerName>Maine Oxy-Acetylene Supply Company</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>990</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19890101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>30142-094-23</NDCCode>
<PackageDescription>72 BLISTER PACK in 1 CARTON (30142-094-23) > 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>30142-0094-23</NDC11Code>
<ProductNDC>30142-094</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nasal Decongestant Pe</ProprietaryName>
<ProprietaryNameSuffix>Non Drowsy Maximum Strength</ProprietaryNameSuffix>
<NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050812</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Kroger Company</LabelerName>
<SubstanceName>PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-12-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050812</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>30142-205-23</NDCCode>
<PackageDescription>251 mL in 1 BOTTLE, PLASTIC (30142-205-23) </PackageDescription>
<NDC11Code>30142-0205-23</NDC11Code>
<ProductNDC>30142-205</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Therapeutic T Plus</ProprietaryName>
<NonProprietaryName>Coal Tar</NonProprietaryName>
<DosageFormName>SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110331</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M032</ApplicationNumber>
<LabelerName>The Kroger Co</LabelerName>
<SubstanceName>COAL TAR</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110331</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>controls the symptoms of: 1 dandruff, 2 seborrheic dermatitis, 3 psoriasis.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>30142-421-23</NDCCode>
<PackageDescription>36 POUCH in 1 CARTON (30142-421-23) > 2 TABLET, EFFERVESCENT in 1 POUCH</PackageDescription>
<NDC11Code>30142-0421-23</NDC11Code>
<ProductNDC>30142-421</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kroger Effervescent Antacid And Pain Relief</ProprietaryName>
<NonProprietaryName>Aspirin, Citric Acid, Sodium Bicarbonate</NonProprietaryName>
<DosageFormName>TABLET, EFFERVESCENT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150113</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>Kroger Company</LabelerName>
<SubstanceName>ANHYDROUS CITRIC ACID; ASPIRIN; SODIUM BICARBONATE</SubstanceName>
<StrengthNumber>1000; 325; 1916</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Alkalinizing Activity [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Cyclooxygenase Inhibitors [MoA], Decreased Coagulation Factor Activity [PE], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150114</StartMarketingDatePackage>
<EndMarketingDatePackage>20221231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Usesfor the temporary relief of. ■ heartburn, acid indigestion and sour stomach when accompanied by headache or body aches and pains. ■ upset stomach with headache from overindulgence in food or drink. ■ pain alone (headaches or body aches and pains).</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>30142-853-23</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (30142-853-23) / 24 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>30142-0853-23</NDC11Code>
<ProductNDC>30142-853</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sinus Congestion</ProprietaryName>
<NonProprietaryName>Phenylephrine Hcl</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210319</StartMarketingDate>
<EndMarketingDate>20290131</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Kroger Company</LabelerName>
<SubstanceName>PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210319</StartMarketingDatePackage>
<EndMarketingDatePackage>20290131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves sinus congestion and pressure. temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>30142-922-23</NDCCode>
<PackageDescription>113 g in 1 BOTTLE, PLASTIC (30142-922-23)</PackageDescription>
<NDC11Code>30142-0922-23</NDC11Code>
<ProductNDC>30142-922</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kroger Sheer Dry Touch Sunscreen</ProprietaryName>
<ProprietaryNameSuffix>Spf 55</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone Homosalate Octisalate Octocrylene Oxybenzone</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130917</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>THE KROGER CO</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>3; 10; 5; 2.8; 6</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g; g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>30142-924-23</NDCCode>
<PackageDescription>113 g in 1 BOTTLE, PLASTIC (30142-924-23)</PackageDescription>
<NDC11Code>30142-0924-23</NDC11Code>
<ProductNDC>30142-924</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kroger Sheer Dry Touch Sunscreen</ProprietaryName>
<ProprietaryNameSuffix>Spf 70</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone Homosalate Octisalate Octocrylene Oxybenzone</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130919</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>THE KROGER CO</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>3; 15; 5; 2.8; 6</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g; g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>30142-953-23</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (30142-953-23) > 24 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>30142-0953-23</NDC11Code>
<ProductNDC>30142-953</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nasal Decongestant</ProprietaryName>
<NonProprietaryName>Phenylephrine Hcl</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190603</StartMarketingDate>
<EndMarketingDate>20230709</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Kroger Company</LabelerName>
<SubstanceName>PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-07-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190603</StartMarketingDatePackage>
<EndMarketingDatePackage>20230709</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>30142-998-23</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (30142-998-23) > 72 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>30142-0998-23</NDC11Code>
<ProductNDC>30142-998</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti Diarrheal</ProprietaryName>
<NonProprietaryName>Loperamide Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030221</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075232</ApplicationNumber>
<LabelerName>Kroger Company</LabelerName>
<SubstanceName>LOPERAMIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140225</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>12213-720-12</NDCCode>
<PackageDescription>7051 L in 1 CYLINDER (12213-720-12) </PackageDescription>
<NDC11Code>12213-0720-12</NDC11Code>
<ProductNDC>12213-720</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxygen</ProprietaryName>
<NonProprietaryName>Oxygen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19960601</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205849</ApplicationNumber>
<LabelerName>NexAir, LLC</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>991</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-02-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19960601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>12213-720-15</NDCCode>
<PackageDescription>1133 L in 1 CYLINDER (12213-720-15) </PackageDescription>
<NDC11Code>12213-0720-15</NDC11Code>
<ProductNDC>12213-720</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxygen</ProprietaryName>
<NonProprietaryName>Oxygen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19960601</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205849</ApplicationNumber>
<LabelerName>NexAir, LLC</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>991</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-02-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19960601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>12213-720-45</NDCCode>
<PackageDescription>41 L in 1 CYLINDER (12213-720-45) </PackageDescription>
<NDC11Code>12213-0720-45</NDC11Code>
<ProductNDC>12213-720</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxygen</ProprietaryName>
<NonProprietaryName>Oxygen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19960601</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205849</ApplicationNumber>
<LabelerName>NexAir, LLC</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>991</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-02-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19960601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>12213-720-50</NDCCode>
<PackageDescription>2350 L in 1 CYLINDER (12213-720-50) </PackageDescription>
<NDC11Code>12213-0720-50</NDC11Code>
<ProductNDC>12213-720</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxygen</ProprietaryName>
<NonProprietaryName>Oxygen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19960601</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205849</ApplicationNumber>
<LabelerName>NexAir, LLC</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>991</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-02-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19960601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>12213-720-58</NDCCode>
<PackageDescription>663 L in 1 CYLINDER (12213-720-58) </PackageDescription>
<NDC11Code>12213-0720-58</NDC11Code>
<ProductNDC>12213-720</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxygen</ProprietaryName>
<NonProprietaryName>Oxygen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19960601</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205849</ApplicationNumber>
<LabelerName>NexAir, LLC</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>991</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-02-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19960601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>46602-0102-5</NDCCode>
<PackageDescription>100 SYRINGE, GLASS in 1 BOX (46602-0102-5) / 2.4 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>46602-0102-05</NDC11Code>
<ProductNDC>46602-0102</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Aripiprazole</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION, EXTENDED RELEASE</DosageFormName>
<StartMarketingDate>20230510</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>OTSUKA PHARMACEUTICAL CO., LTD.</LabelerName>
<SubstanceName>ARIPIPRAZOLE</SubstanceName>
<StrengthNumber>720</StrengthNumber>
<StrengthUnit>mg/2.4mL</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2023-05-15</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>10-MAY-23</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>50102-220-23</NDCCode>
<PackageDescription>3 POUCH in 1 CARTON (50102-220-23) / 1 BLISTER PACK in 1 POUCH (50102-220-21) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>50102-0220-23</NDC11Code>
<ProductNDC>50102-220</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aubra Eq</ProprietaryName>
<NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20161114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206886</ApplicationNumber>
<LabelerName>Afaxys Pharma, LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-08-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<IndicationAndUsage>Aubra EQ 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. Emergency Contraceptive Pills: The FDA has concluded that certain combined oral contraceptives containing ethinyl estradiol and norgestrel or levonorgestrel are safe and effective for use as postcoital emergency contraception. Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9. Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraception.10. Source: Trussell J. Contraceptive efficacy. In: Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowel D, Guest F. Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers; 1998. 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. 9. The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following dosage regimens of oral contraceptives to be safe and effective for emergency contraception: for tablets containing 50 mcg of ethinyl estradiol and 500 mcg of norgestrel 1 dose is 2 tablets; for tablets containing 20 mcg of ethinyl estradiol and 100 mcg of levonorgestrel 1 dose is 5 tablets; for tablets containing 30 mcg of ethinyl estradiol and 150 mcg of levonorgestrel 1 dose is 4 tablets. 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. 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.</IndicationAndUsage>
<Description>Each active, white tablet (21) contains 0.1 mg of levonorgestrel USP, d(-)-13β-ethyl-17α- ethinyl-17β-hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol USP, 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, green tablet (7) contains the following inactive ingredients: croscarmellose sodium, FD & C Blue No. 2 Aluminum Lake, ferric oxide (sicovit yellow 10), lactose anhydrous, magnesium stearate, microcrystalline cellulose, and povidone.</Description>
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<NDC>
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<PackageDescription>1 KIT in 1 CARTON (55118-978-01) * 14 mL in 1 CUP, UNIT-DOSE * 10 g in 1 TUBE * 10 CUP, UNIT-DOSE in 1 TRAY (50383-720-15) > 15 mL in 1 CUP, UNIT-DOSE * 14 mL in 1 CUP, UNIT-DOSE (55118-991-01)</PackageDescription>
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<ProprietaryNameSuffix>Oral Care Q2 Kit With Chg</ProprietaryNameSuffix>
<NonProprietaryName>Hydrogen Peroxide And Chlorhexidine Gluconate</NonProprietaryName>
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<EndMarketingDate>20250430</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
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<LabelerName>RedHill Biopharma Ltd</LabelerName>
<SubstanceName>RIFAMYCIN</SubstanceName>
<StrengthNumber>194</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Rifamycin Antibacterial [EPC], Rifamycins [CS]</Pharm_Classes>
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<LastUpdate>2025-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<IndicationAndUsage>AEMCOLO is a rifamycin antibacterial indicated for the treatment of travelers' diarrhea caused by noninvasive strains of Escherichia coliin adults. ( 1.1). Limitations of Use:. AEMCOLO is not recommended for use in patients with diarrhea complicated by fever and/or bloody stool or due to pathogens other than noninvasive strains of E. coli.( 1, 5.1, 14). To reduce the development of drug-resistant bacteria and maintain the effectiveness of AEMCOLO and other antibacterial drugs, AEMCOLO should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria ( 1.2).</IndicationAndUsage>
<Description>AEMCOLO, delayed-release tablet, for oral administration, contains 194 mg of rifamycin equivalent to 200 mg of rifamycin sodium. Rifamycin sodium is a rifamycin antibacterial. It is designated chemically as: Sodium (2S,12Z,14E,16S,17S,18R,19R,20R,21S,22R,23S,24E)-21-(acetyloxy)-6,9,17,19-tetrahydroxy-23-methoxy-2,4,12,16,18,20,22-heptamethyl-1,11-dioxo-1,2-dihydro-2,7-(epoxypentadeca[1,11,13]trienimino)naphtho[2,1- b]furan-5-olate. Its empirical formula is C 37H 46NNaO 12. The molecular weight is 720 g/mol. Its structural formula is. Rifamycin sodium is a fine or slightly granular powder, soluble in water, and freely soluble in anhydrous ethanol. AEMCOLO, delayed-release tablets are enteric coated with a pH-resistant polymer film which breaks down above pH 7. The tablet core contains rifamycin. The tablets are yellow brown and ellipsoidal. Each tablet contains the following inactive ingredients: ammonio methacrylate copolymer (Type B), ascorbic acid, glyceryl distearate, lecithin, magnesium stearate, mannitol, methacrylic acid and methyl methacrylate copolymer (1:2), polyethylene glycol 6000, colloidal silicon dioxide, talc, titanium dioxide, triethylcitrate, yellow ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>57841-1200-2</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 CARTON (57841-1200-2) / 6 TABLET, DELAYED RELEASE in 1 BLISTER PACK (57841-1200-0) </PackageDescription>
<NDC11Code>57841-1200-02</NDC11Code>
<ProductNDC>57841-1200</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aemcolo</ProprietaryName>
<NonProprietaryName>Rifamycin</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210701</StartMarketingDate>
<EndMarketingDate>20250430</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210910</ApplicationNumber>
<LabelerName>RedHill Biopharma Ltd</LabelerName>
<SubstanceName>RIFAMYCIN</SubstanceName>
<StrengthNumber>194</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Rifamycin Antibacterial [EPC], Rifamycins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210701</StartMarketingDatePackage>
<EndMarketingDatePackage>20250430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AEMCOLO is a rifamycin antibacterial indicated for the treatment of travelers' diarrhea caused by noninvasive strains of Escherichia coliin adults. ( 1.1). Limitations of Use:. AEMCOLO is not recommended for use in patients with diarrhea complicated by fever and/or bloody stool or due to pathogens other than noninvasive strains of E. coli.( 1, 5.1, 14). To reduce the development of drug-resistant bacteria and maintain the effectiveness of AEMCOLO and other antibacterial drugs, AEMCOLO should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria ( 1.2).</IndicationAndUsage>
<Description>AEMCOLO, delayed-release tablet, for oral administration, contains 194 mg of rifamycin equivalent to 200 mg of rifamycin sodium. Rifamycin sodium is a rifamycin antibacterial. It is designated chemically as: Sodium (2S,12Z,14E,16S,17S,18R,19R,20R,21S,22R,23S,24E)-21-(acetyloxy)-6,9,17,19-tetrahydroxy-23-methoxy-2,4,12,16,18,20,22-heptamethyl-1,11-dioxo-1,2-dihydro-2,7-(epoxypentadeca[1,11,13]trienimino)naphtho[2,1- b]furan-5-olate. Its empirical formula is C 37H 46NNaO 12. The molecular weight is 720 g/mol. Its structural formula is. Rifamycin sodium is a fine or slightly granular powder, soluble in water, and freely soluble in anhydrous ethanol. AEMCOLO, delayed-release tablets are enteric coated with a pH-resistant polymer film which breaks down above pH 7. The tablet core contains rifamycin. The tablets are yellow brown and ellipsoidal. Each tablet contains the following inactive ingredients: ammonio methacrylate copolymer (Type B), ascorbic acid, glyceryl distearate, lecithin, magnesium stearate, mannitol, methacrylic acid and methyl methacrylate copolymer (1:2), polyethylene glycol 6000, colloidal silicon dioxide, talc, titanium dioxide, triethylcitrate, yellow ferric oxide.</Description>
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<NDC>
<NDCCode>57841-1201-1</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (57841-1201-1) / 4 TABLET, DELAYED RELEASE in 1 BLISTER PACK (57841-1201-0) </PackageDescription>
<NDC11Code>57841-1201-01</NDC11Code>
<ProductNDC>57841-1201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aemcolo</ProprietaryName>
<NonProprietaryName>Rifamycin</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210701</StartMarketingDate>
<EndMarketingDate>20250430</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210910</ApplicationNumber>
<LabelerName>RedHill Biopharma Ltd</LabelerName>
<SubstanceName>RIFAMYCIN</SubstanceName>
<StrengthNumber>194</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Rifamycin Antibacterial [EPC], Rifamycins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210701</StartMarketingDatePackage>
<EndMarketingDatePackage>20250430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AEMCOLO is a rifamycin antibacterial indicated for the treatment of travelers' diarrhea caused by noninvasive strains of Escherichia coliin adults. ( 1.1). Limitations of Use:. AEMCOLO is not recommended for use in patients with diarrhea complicated by fever and/or bloody stool or due to pathogens other than noninvasive strains of E. coli.( 1, 5.1, 14). To reduce the development of drug-resistant bacteria and maintain the effectiveness of AEMCOLO and other antibacterial drugs, AEMCOLO should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria ( 1.2).</IndicationAndUsage>
<Description>AEMCOLO, delayed-release tablet, for oral administration, contains 194 mg of rifamycin equivalent to 200 mg of rifamycin sodium. Rifamycin sodium is a rifamycin antibacterial. It is designated chemically as: Sodium (2S,12Z,14E,16S,17S,18R,19R,20R,21S,22R,23S,24E)-21-(acetyloxy)-6,9,17,19-tetrahydroxy-23-methoxy-2,4,12,16,18,20,22-heptamethyl-1,11-dioxo-1,2-dihydro-2,7-(epoxypentadeca[1,11,13]trienimino)naphtho[2,1- b]furan-5-olate. Its empirical formula is C 37H 46NNaO 12. The molecular weight is 720 g/mol. Its structural formula is. Rifamycin sodium is a fine or slightly granular powder, soluble in water, and freely soluble in anhydrous ethanol. AEMCOLO, delayed-release tablets are enteric coated with a pH-resistant polymer film which breaks down above pH 7. The tablet core contains rifamycin. The tablets are yellow brown and ellipsoidal. Each tablet contains the following inactive ingredients: ammonio methacrylate copolymer (Type B), ascorbic acid, glyceryl distearate, lecithin, magnesium stearate, mannitol, methacrylic acid and methyl methacrylate copolymer (1:2), polyethylene glycol 6000, colloidal silicon dioxide, talc, titanium dioxide, triethylcitrate, yellow ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>59651-720-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (59651-720-01) </PackageDescription>
<NDC11Code>59651-0720-01</NDC11Code>
<ProductNDC>59651-720</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dicyclomine Hydrochloride</ProprietaryName>
<NonProprietaryName>Dicyclomine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230425</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040317</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>DICYCLOMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-05-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230425</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/ irritable bowel syndrome.</IndicationAndUsage>
<Description>Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent. Chemically, dicyclomine hydrochloride is [bicyclohexyl]-1-carboxylic acid, 2-(diethylamino) ethyl ester, hydrochloride with the following structural formula, molecular weight, and molecular formula:. Dicyclomine hydrochloride, USP occurs as a white crystalline powder. It is soluble in water, freely soluble in alcohol and chloroform, and very slightly soluble in ether. Dicyclomine hydrochloride tablets, USP for oral administration contain 20 mg of dicyclomine hydrochloride, USP. In addition each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, FD&C Blue No. 1 Aluminum Lake, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>59651-720-99</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (59651-720-99) </PackageDescription>
<NDC11Code>59651-0720-99</NDC11Code>
<ProductNDC>59651-720</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dicyclomine Hydrochloride</ProprietaryName>
<NonProprietaryName>Dicyclomine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230425</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040317</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>DICYCLOMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-05-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230425</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/ irritable bowel syndrome.</IndicationAndUsage>
<Description>Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent. Chemically, dicyclomine hydrochloride is [bicyclohexyl]-1-carboxylic acid, 2-(diethylamino) ethyl ester, hydrochloride with the following structural formula, molecular weight, and molecular formula:. Dicyclomine hydrochloride, USP occurs as a white crystalline powder. It is soluble in water, freely soluble in alcohol and chloroform, and very slightly soluble in ether. Dicyclomine hydrochloride tablets, USP for oral administration contain 20 mg of dicyclomine hydrochloride, USP. In addition each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, FD&C Blue No. 1 Aluminum Lake, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>60274-720-01</NDCCode>
<PackageDescription>96000 CAPSULE, EXTENDED RELEASE in 1 DRUM (60274-720-01) </PackageDescription>
<NDC11Code>60274-0720-01</NDC11Code>
<ProductNDC>60274-720</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Dexmethylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<StartMarketingDate>20050531</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Societal CDMO Gainesville, LLC</LabelerName>
<SubstanceName>DEXMETHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CII</DEASchedule>
<Status>Unfinished</Status>
<LastUpdate>2022-11-23</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>31-MAY-05</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>63304-720-05</NDCCode>
<PackageDescription>500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63304-720-05) </PackageDescription>
<NDC11Code>63304-0720-05</NDC11Code>
<ProductNDC>63304-720</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181031</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203023</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>240</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181031</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem hydrochloride extended-release capsules, USP are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules, USP are indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
<Description>Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1, 5-Benzothiazepin-4(5 H)-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)- cis-. The chemical structure is:. Diltiazem hydrochloride, USP is a white, odorless crystalline powder or small crystals. It is freely soluble in chloroform, formic acid, methanol, and water. It is sparingly soluble in dehydrated alcohol and is insoluble in ether. It has a molecular weight of 450.98. Diltiazem hydrochloride is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride, USP (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride, USP (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride, USP (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride, USP (equivalent to 330.9 mg diltiazem). The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsules also contain: acetyl tributyl citrate, ammonio methacrylate copolymer dispersion, hypromellose, sodium lauryl sulfate, sugar spheres (sucrose and corn starch), and talc. The 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg capsule shells contain FD&C Blue #1, gelatin, sodium lauryl sulfate, and titanium dioxide. The 180 mg, 240 mg, 300 mg, and 360 mg capsule shells also contain iron oxide black. The 120 mg, 180 mg, 300 mg, and 360 mg capsules are imprinted with black ink which contains iron oxide black, potassium hydroxide, propylene glycol, and shellac. The 240 mg capsules are imprinted with white ink which contains potassium hydroxide, propylene glycol, shellac, and titanium dioxide. For oral administration. Meets USP dissolution test 29.</Description>
</NDC>
<NDC>
<NDCCode>63304-720-30</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63304-720-30) </PackageDescription>
<NDC11Code>63304-0720-30</NDC11Code>
<ProductNDC>63304-720</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181031</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203023</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>240</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181031</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem hydrochloride extended-release capsules, USP are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules, USP are indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
<Description>Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1, 5-Benzothiazepin-4(5 H)-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)- cis-. The chemical structure is:. Diltiazem hydrochloride, USP is a white, odorless crystalline powder or small crystals. It is freely soluble in chloroform, formic acid, methanol, and water. It is sparingly soluble in dehydrated alcohol and is insoluble in ether. It has a molecular weight of 450.98. Diltiazem hydrochloride is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride, USP (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride, USP (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride, USP (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride, USP (equivalent to 330.9 mg diltiazem). The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsules also contain: acetyl tributyl citrate, ammonio methacrylate copolymer dispersion, hypromellose, sodium lauryl sulfate, sugar spheres (sucrose and corn starch), and talc. The 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg capsule shells contain FD&C Blue #1, gelatin, sodium lauryl sulfate, and titanium dioxide. The 180 mg, 240 mg, 300 mg, and 360 mg capsule shells also contain iron oxide black. The 120 mg, 180 mg, 300 mg, and 360 mg capsules are imprinted with black ink which contains iron oxide black, potassium hydroxide, propylene glycol, and shellac. The 240 mg capsules are imprinted with white ink which contains potassium hydroxide, propylene glycol, shellac, and titanium dioxide. For oral administration. Meets USP dissolution test 29.</Description>
</NDC>
<NDC>
<NDCCode>63304-720-90</NDCCode>
<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63304-720-90) </PackageDescription>
<NDC11Code>63304-0720-90</NDC11Code>
<ProductNDC>63304-720</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181031</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203023</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>240</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181031</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem hydrochloride extended-release capsules, USP are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules, USP are indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
<Description>Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1, 5-Benzothiazepin-4(5 H)-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)- cis-. The chemical structure is:. Diltiazem hydrochloride, USP is a white, odorless crystalline powder or small crystals. It is freely soluble in chloroform, formic acid, methanol, and water. It is sparingly soluble in dehydrated alcohol and is insoluble in ether. It has a molecular weight of 450.98. Diltiazem hydrochloride is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride, USP (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride, USP (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride, USP (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride, USP (equivalent to 330.9 mg diltiazem). The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsules also contain: acetyl tributyl citrate, ammonio methacrylate copolymer dispersion, hypromellose, sodium lauryl sulfate, sugar spheres (sucrose and corn starch), and talc. The 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg capsule shells contain FD&C Blue #1, gelatin, sodium lauryl sulfate, and titanium dioxide. The 180 mg, 240 mg, 300 mg, and 360 mg capsule shells also contain iron oxide black. The 120 mg, 180 mg, 300 mg, and 360 mg capsules are imprinted with black ink which contains iron oxide black, potassium hydroxide, propylene glycol, and shellac. The 240 mg capsules are imprinted with white ink which contains potassium hydroxide, propylene glycol, shellac, and titanium dioxide. For oral administration. Meets USP dissolution test 29.</Description>
</NDC>
<NDC>
<NDCCode>67877-720-31</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 CARTON (67877-720-31) / 10 TABLET in 1 BLISTER PACK (67877-720-33) </PackageDescription>
<NDC11Code>67877-0720-31</NDC11Code>
<ProductNDC>67877-720</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Everolimus</ProprietaryName>
<NonProprietaryName>Everolimus</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214138</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>EVEROLIMUS</SubstanceName>
<StrengthNumber>.75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Everolimus tablets are a mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients: Kidney Transplant: at low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids (1.1) Liver Transplant: Administer no earlier than 30 days posttransplant. Use in combination with tacrolimus (reduced doses) and corticosteroids (1.2, 5.5). Limitations of Use: Safety and efficacy have not been established in the following: Kidney transplant patients at high immunologic risk (1.3) Recipients of transplanted organs other than kidney or liver (1.3, 5.7) Pediatric patients (less than 18 years) (1.3).</IndicationAndUsage>
<Description>Everolimus is a macrolide immunosuppressant. The chemical name of everolimus is (1R, 9S, 12S, 15R, 16E, 18R, 19R, 21R, 23S, 24E, 26E, 28E, 30S, 32S, 35R)-1, 18-dihydroxy-12 -{(1R)-2-[(1S,3R,4R) 4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15, 17, 21, 23, 29, 35-hexamethyl-11, 36 dioxa-4-aza-tricyclo[30.3.1.04,9] hexatriaconta-16,24,26,28-tetraene-2, 3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.25. The structural formula is. Everolimus is supplied as tablets for oral administration containing 0.25 mg, 0.5 mg, 0.75 mg and 1 mg of everolimus together with butylated hydroxytoluene, crospovidone type A, hypromellose, lactose anhydrous, lactose monohydrate and magnesium stearate as inactive ingredients.</Description>
</NDC>
</NDCList>