{
"NDC": [
{
"NDCCode": "41520-565-46",
"PackageDescription": "130 g in 1 CAN (41520-565-46) ",
"NDC11Code": "41520-0565-46",
"ProductNDC": "41520-565",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Miconazole Nitrate",
"NonProprietaryName": "Anti-fungal Miconazole Athletes Foot Spray Talc Free",
"DosageFormName": "AEROSOL, POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171020",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M005",
"LabelerName": "Foodhold USA",
"SubstanceName": "MICONAZOLE NITRATE",
"StrengthNumber": "2.6",
"StrengthUnit": "g/130g",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171020",
"SamplePackage": "N",
"IndicationAndUsage": "cures most athlete's foot (linea pedis), ringworm (linea corporis) and jock itch (linea cruris). relieves symptoms of athlete's foot, including itching burning and cracking."
},
{
"NDCCode": "41520-087-46",
"PackageDescription": "131 g in 1 CAN (41520-087-46) ",
"NDC11Code": "41520-0087-46",
"ProductNDC": "41520-087",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Miconazole Nitrate",
"NonProprietaryName": "Jock Itch Spray",
"DosageFormName": "AEROSOL, SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171219",
"EndMarketingDate": "20200302",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333C",
"LabelerName": "Foodhold USA",
"SubstanceName": "MICONAZOLE NITRATE",
"StrengthNumber": "1.3",
"StrengthUnit": "g/131g",
"Status": "Deprecated",
"LastUpdate": "2020-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20171219",
"EndMarketingDatePackage": "20200302",
"SamplePackage": "N"
},
{
"NDCCode": "41520-088-46",
"PackageDescription": "130 g in 1 CAN (41520-088-46) ",
"NDC11Code": "41520-0088-46",
"ProductNDC": "41520-088",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Miconazole Nitrate",
"NonProprietaryName": "Miconazole Nitrate Antifungal Powder Spray",
"DosageFormName": "AEROSOL, SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120103",
"EndMarketingDate": "20200312",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333C",
"LabelerName": "Foodhold USA",
"SubstanceName": "MICONAZOLE NITRATE",
"StrengthNumber": "2.6",
"StrengthUnit": "g/130g",
"Status": "Deprecated",
"LastUpdate": "2020-03-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20120103",
"EndMarketingDatePackage": "20200312",
"SamplePackage": "N"
},
{
"NDCCode": "41520-566-46",
"PackageDescription": "130 g in 1 CAN (41520-566-46) ",
"NDC11Code": "41520-0566-46",
"ProductNDC": "41520-566",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Miconazole Nitrate",
"NonProprietaryName": "Jock Itch Spray Talc Free",
"DosageFormName": "AEROSOL, SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171020",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M005",
"LabelerName": "American Sales Company",
"SubstanceName": "MICONAZOLE NITRATE",
"StrengthNumber": "1.3",
"StrengthUnit": "g/130g",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"Status": "Active",
"LastUpdate": "2025-10-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171020",
"SamplePackage": "N",
"IndicationAndUsage": "cures most jock itch (tinea cruris). relieves symptoms of jock itch including itching, burning and chafing associated with jock itch."
},
{
"NDCCode": "41520-612-46",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (41520-612-46) / 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "41520-0612-46",
"ProductNDC": "41520-612",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Careone Allergy Relief",
"ProprietaryNameSuffix": "24 Hour",
"NonProprietaryName": "Loratadine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060602",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076301",
"LabelerName": "American Sales Company",
"SubstanceName": "LORATADINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-07-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20060602",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 itchy, watery eyes, 3 sneezing, 4 itching of the nose or throat."
},
{
"NDCCode": "65162-316-84",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (65162-316-84) > 1 KIT in 1 BLISTER PACK (65162-316-58)",
"NDC11Code": "65162-0316-84",
"ProductNDC": "65162-316",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lomedia 24 Fe",
"NonProprietaryName": "Norethindrone Acetate And Ethinyl Estradiol",
"DosageFormName": "KIT",
"RouteName": "ORAL",
"StartMarketingDate": "20131220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078267",
"LabelerName": "Amneal Pharmaceuticals of New York, LLC",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Lomedia 24 Fe tablets are 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 2 lists the typical unplanned pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant®* system, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. TABLE 2Percentage of women experiencing an unintended pregnancy during the first year of typical use and the first year of perfect use of contraception and the percentage continuing use at the end of the first year. United States. Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces risk of pregnancy by at least 75%9. Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception. Source: Trussell J, Stewart F, Contraceptive Efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal 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 percentage of women becoming pregnant noted 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% became pregnant in one year. This estimate was lowered slightly (to 85%) to represent the percentage that would become pregnant within one year among women now relying on reversible methods of contraception if they abandon contraception altogether. 5 Foams, creams, gels, vaginal suppositories and vaginal film. 6 Cervical mucous (ovulation) method supplemented by calendar in the preovulatory and basal body temperature in the postovulatory phases. 7 With spermicidal cream or jelly. 8 Without spermicides. 9 The treatment schedule is one dose within 72 hours after unprotected intercourse and a second dose 12 hours after the first dose. The Food and Drug Administration has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral®* (1 dose is 2 white pills), Alesse®* (1 dose is 5 pink pills), Nordette®* or Levlen®* (1 dose is 2 light orange pills), Lo/Ovral®* (1 dose is 4 white pills), Triphasil®* or Tri-Levlen®* (1 dose is 4 yellow pills). 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 six months of age. Clinical Studies. In a clinical study, 743 women, 18 to 45 years of age, were treated with Lomedia24 Fe for up to six 28-day cycles providing a total of 3,823 treatment-cycles of exposure. A total of 583 women completed 6 cycles of treatment. There were a total of 5 on-treatment pregnancies in 3,565 treatment cycles during which no backup contraception was used. The Pearl Index for Lomedia24 Fe was 1.82.",
"Description": "Lomedia® 24 Fe provides a dosage regimen consisting of 24 white progestogen-estrogen contraceptive tablets and 4 brown ferrous fumarate (placebo) tablets. Each white tablet contains 1 mg norethindrone acetate and 20 mcg ethinyl estradiol. Each white tablet also contains the following inactive ingredients: povidone, anhydrous lactose, microcrystalline cellulose, polacrilin potassium and magnesium stearate. Each brown tablet contains ferrous fumarate, pregelatinized starch, anhydrous lactose, crospovidone, magnesium stearate. The ferrous fumarate tablets do not serve any therapeutic purpose. Ethinyl Estradiol has a molecular weight of 296.40 and a molecular formula of C20H24O2. Norethindrone Acetate has a molecular weight of 340.46 and a molecular formula of C22H28O3. The structural formulas for the active hormones are. Ethinyl Estradiol [19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-]. Norethindrone Acetate [19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17α)-]."
},
{
"NDCCode": "41520-161-08",
"PackageDescription": "221 mL in 1 BOTTLE, PUMP (41520-161-08)",
"NDC11Code": "41520-0161-08",
"ProductNDC": "41520-161",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antibacterial Foaming",
"NonProprietaryName": "Triclosan",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110516",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "AMERICAN SALES COMPANY",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": ".46",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "For hand washing to decrease bacteria on the skin."
},
{
"NDCCode": "41520-165-08",
"PackageDescription": "221 mL in 1 BOTTLE, PUMP (41520-165-08)",
"NDC11Code": "41520-0165-08",
"ProductNDC": "41520-165",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antibacterial Foaming",
"ProprietaryNameSuffix": "Green Tea",
"NonProprietaryName": "Triclosan",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110516",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "AMERICAN SALES COMPANY",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": ".46",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "For hand washing to decrease bacteria on the skin."
},
{
"NDCCode": "41520-169-08",
"PackageDescription": "221 mL in 1 BOTTLE, PUMP (41520-169-08)",
"NDC11Code": "41520-0169-08",
"ProductNDC": "41520-169",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antibacterial Foaming",
"NonProprietaryName": "Triclosan",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110516",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "AMERICAN SALES COMPANY",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": ".46",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "For hand washing to decrease bacteria on the skin."
},
{
"NDCCode": "0143-9558-01",
"PackageDescription": "1 VIAL in 1 BOX (0143-9558-01) > 5 mL in 1 VIAL",
"NDC11Code": "00143-9558-01",
"ProductNDC": "0143-9558",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levoleucovorin",
"NonProprietaryName": "Levoleucovorin",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20160707",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206263",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "LEVOLEUCOVORIN CALCIUM",
"StrengthNumber": "50",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Folate Analog [EPC], Folic Acid [CS]",
"Status": "Active",
"LastUpdate": "2021-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160707",
"SamplePackage": "N",
"IndicationAndUsage": "Levoleucovorin for Injection is indicated for: 1 rescue after high-dose methotrexate therapy in adult and pediatric patients with osteosarcoma., 2 diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination in adult and pediatric patients., 3 the treatment of adults with metastatic colorectal cancer in combination with fluorouracil. .",
"Description": "Levoleucovorin is a folate analog and the pharmacologically active levo-isomer of d,l-leucovorin. The chemical name of levoleucovorin calcium is Calcium N-[p-[[[(6S)-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6- pteridinyl]methyl]amino]benzoyl]-L-glutamate (1:1) mixed hydrate. The molecular formula is C20H21CaN7O7 .nH2O (n = 3 to 6) and the molecular weight is 565.6 to 619.6. The molecular structure is. Levoleucovorin for Injection, for intravenous use is supplied as a sterile white to pale yellow lyophilized powder consisting of 50 mg levoleucovorin (equivalent to 64 mg levoleucovorin calcium mixed hydrate) and 50 mg mannitol per 50 mg single dose vial. Sodium hydroxide and/or hydrochloric acid are used to adjust the pH."
},
{
"NDCCode": "0228-4270-11",
"PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0228-4270-11) ",
"NDC11Code": "00228-4270-11",
"ProductNDC": "0228-4270",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Morphine Sulfate",
"NonProprietaryName": "Morphine Sulfate",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20151026",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203849",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "MORPHINE SULFATE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20151026",
"SamplePackage": "N",
"IndicationAndUsage": "Morphine sulfate extended-release tablets are indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations [see Warnings and Precautions (5.1)], reserve morphine sulfate extended-release for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Morphine sulfate extended-release tablets are not indicated as an as-needed (prn) analgesic.",
"Description": "Morphine sulfate extended-release tablets are for oral use and contain morphine sulfate, USP an opioid agonist. Each tablet contains the following inactive ingredients common to all strengths: anhydrous lactose, cetostearyl alcohol, hydroxyethyl cellulose, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. The 30 mg tablets also contain yellow iron oxide. The 60 mg tablets also contain red iron oxide. The 100 mg and 200 mg tablets also contain red iron oxide and yellow iron oxide. The tablet strengths, 15 mg, 30 mg, 60 mg, 100 mg, and 200 mg, describe the amount of morphine per tablet as the pentahydrated sulfate salt (morphine sulfate). Morphine sulfate, USP is an odorless, white, crystalline powder with a bitter taste. Morphine sulfate, USP is soluble in water and ethanol. 1 g dissolves in 15.5 mL of water at 25°C and 1 g dissolves in 565 mL of ethanol at 25°C. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its molecular weight is 758.83 and its structural formula is."
},
{
"NDCCode": "0228-4311-11",
"PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0228-4311-11) ",
"NDC11Code": "00228-4311-11",
"ProductNDC": "0228-4311",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Morphine Sulfate",
"NonProprietaryName": "Morphine Sulfate",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20151026",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203849",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "MORPHINE SULFATE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20151026",
"SamplePackage": "N",
"IndicationAndUsage": "Morphine sulfate extended-release tablets are indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations [see Warnings and Precautions (5.1)], reserve morphine sulfate extended-release for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Morphine sulfate extended-release tablets are not indicated as an as-needed (prn) analgesic.",
"Description": "Morphine sulfate extended-release tablets are for oral use and contain morphine sulfate, USP an opioid agonist. Each tablet contains the following inactive ingredients common to all strengths: anhydrous lactose, cetostearyl alcohol, hydroxyethyl cellulose, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. The 30 mg tablets also contain yellow iron oxide. The 60 mg tablets also contain red iron oxide. The 100 mg and 200 mg tablets also contain red iron oxide and yellow iron oxide. The tablet strengths, 15 mg, 30 mg, 60 mg, 100 mg, and 200 mg, describe the amount of morphine per tablet as the pentahydrated sulfate salt (morphine sulfate). Morphine sulfate, USP is an odorless, white, crystalline powder with a bitter taste. Morphine sulfate, USP is soluble in water and ethanol. 1 g dissolves in 15.5 mL of water at 25°C and 1 g dissolves in 565 mL of ethanol at 25°C. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its molecular weight is 758.83 and its structural formula is."
},
{
"NDCCode": "0228-4323-11",
"PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0228-4323-11) ",
"NDC11Code": "00228-4323-11",
"ProductNDC": "0228-4323",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Morphine Sulfate",
"NonProprietaryName": "Morphine Sulfate",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20151026",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203849",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "MORPHINE SULFATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20151026",
"SamplePackage": "N",
"IndicationAndUsage": "Morphine sulfate extended-release tablets are indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations [see Warnings and Precautions (5.1)], reserve morphine sulfate extended-release for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Morphine sulfate extended-release tablets are not indicated as an as-needed (prn) analgesic.",
"Description": "Morphine sulfate extended-release tablets are for oral use and contain morphine sulfate, USP an opioid agonist. Each tablet contains the following inactive ingredients common to all strengths: anhydrous lactose, cetostearyl alcohol, hydroxyethyl cellulose, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. The 30 mg tablets also contain yellow iron oxide. The 60 mg tablets also contain red iron oxide. The 100 mg and 200 mg tablets also contain red iron oxide and yellow iron oxide. The tablet strengths, 15 mg, 30 mg, 60 mg, 100 mg, and 200 mg, describe the amount of morphine per tablet as the pentahydrated sulfate salt (morphine sulfate). Morphine sulfate, USP is an odorless, white, crystalline powder with a bitter taste. Morphine sulfate, USP is soluble in water and ethanol. 1 g dissolves in 15.5 mL of water at 25°C and 1 g dissolves in 565 mL of ethanol at 25°C. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its molecular weight is 758.83 and its structural formula is."
},
{
"NDCCode": "0228-4347-11",
"PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0228-4347-11) ",
"NDC11Code": "00228-4347-11",
"ProductNDC": "0228-4347",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Morphine Sulfate",
"NonProprietaryName": "Morphine Sulfate",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20151026",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203849",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "MORPHINE SULFATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20151026",
"SamplePackage": "N",
"IndicationAndUsage": "Morphine sulfate extended-release tablets are indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations [see Warnings and Precautions (5.1)], reserve morphine sulfate extended-release for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Morphine sulfate extended-release tablets are not indicated as an as-needed (prn) analgesic.",
"Description": "Morphine sulfate extended-release tablets are for oral use and contain morphine sulfate, USP an opioid agonist. Each tablet contains the following inactive ingredients common to all strengths: anhydrous lactose, cetostearyl alcohol, hydroxyethyl cellulose, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. The 30 mg tablets also contain yellow iron oxide. The 60 mg tablets also contain red iron oxide. The 100 mg and 200 mg tablets also contain red iron oxide and yellow iron oxide. The tablet strengths, 15 mg, 30 mg, 60 mg, 100 mg, and 200 mg, describe the amount of morphine per tablet as the pentahydrated sulfate salt (morphine sulfate). Morphine sulfate, USP is an odorless, white, crystalline powder with a bitter taste. Morphine sulfate, USP is soluble in water and ethanol. 1 g dissolves in 15.5 mL of water at 25°C and 1 g dissolves in 565 mL of ethanol at 25°C. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its molecular weight is 758.83 and its structural formula is."
},
{
"NDCCode": "0406-0187-33",
"PackageDescription": "565 kg in 1 SUPERSACK (0406-0187-33)",
"NDC11Code": "00406-0187-33",
"ProductNDC": "0406-0187",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "P-aminophenol",
"DosageFormName": "POWDER",
"StartMarketingDate": "20130219",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Mallinckrodt, Inc.",
"SubstanceName": "P-AMINOPHENOL",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0406-0960-34",
"PackageDescription": "565 kg in 1 SUPERSACK (0406-0960-34) ",
"NDC11Code": "00406-0960-34",
"ProductNDC": "0406-0960",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Acetaminophen Anhydrous Basis",
"DosageFormName": "POWDER",
"StartMarketingDate": "19821220",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "SpecGx LLC",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": ".9",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2026-07-27",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20-DEC-82"
},
{
"NDCCode": "10356-565-16",
"PackageDescription": "75 mL in 1 TUBE (10356-565-16)",
"NDC11Code": "10356-0565-16",
"ProductNDC": "10356-565",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nivea For Men Protective",
"NonProprietaryName": "Octinoxate, Avobenzone, Oxybenzone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120615",
"EndMarketingDate": "20171231",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Beiersdorf Inc",
"SubstanceName": "OCTINOXATE; AVOBENZONE; OXYBENZONE",
"StrengthNumber": "6; 2; 2",
"StrengthUnit": "g/100mL; g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2018-01-04",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "10544-565-30",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10544-565-30)",
"NDC11Code": "10544-0565-30",
"ProductNDC": "10544-565",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20131113",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA018279",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS, OR FOR PATIENTS WITH WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS. : 1 1.For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication, and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia., 2 2.For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias.",
"Description": "Potassium chloride extended-release tablets is a solid oral dosage form of potassium chloride containing 8 mEq, 10 mEq and 20 mEq of potassium chloride, USP, equivalent to 600 mg, 750 mg and 1500 mg of potassium, respectively, in a film-coated (not enteric-coated), wax matrix tablet. These formulations are intended to slow the release of potassium so that the likelihood of a high localized concentration of potassium chloride within the gastrointestinal tract is reduced. The expended inert, porous, wax/polymer matrix is not absorbed and may be excreted intact in the stool. Potassium chloride extended-release tablets are an electrolyte replenisher. The chemical name is potassium chloride, and the structural formula is KCl. Potassium chloride, USP, occurs as a white, granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol."
},
{
"NDCCode": "10544-565-90",
"PackageDescription": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10544-565-90)",
"NDC11Code": "10544-0565-90",
"ProductNDC": "10544-565",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20131113",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA018279",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS, OR FOR PATIENTS WITH WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS. : 1 1.For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication, and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia., 2 2.For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias.",
"Description": "Potassium chloride extended-release tablets is a solid oral dosage form of potassium chloride containing 8 mEq, 10 mEq and 20 mEq of potassium chloride, USP, equivalent to 600 mg, 750 mg and 1500 mg of potassium, respectively, in a film-coated (not enteric-coated), wax matrix tablet. These formulations are intended to slow the release of potassium so that the likelihood of a high localized concentration of potassium chloride within the gastrointestinal tract is reduced. The expended inert, porous, wax/polymer matrix is not absorbed and may be excreted intact in the stool. Potassium chloride extended-release tablets are an electrolyte replenisher. The chemical name is potassium chloride, and the structural formula is KCl. Potassium chloride, USP, occurs as a white, granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol."
},
{
"NDCCode": "12497-1042-1",
"PackageDescription": "1 BAG in 1 DRUM (12497-1042-1) > 50 kg in 1 BAG",
"NDC11Code": "12497-1042-01",
"ProductNDC": "12497-1042",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Amino Acid Mixture Ko80",
"DosageFormName": "POWDER",
"StartMarketingDate": "19871118",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Kyowa Hakko Bio Co., Ltd.",
"SubstanceName": "THREONINE; METHIONINE; SERINE; ISOLEUCINE; LEUCINE; GLYCINE; VALINE; ARGININE; HISTIDINE; ALANINE; PROLINE",
"StrengthNumber": "3.125; .695; 3.475; 6.26; 7.65; 6.26; 5.84; 4.17; 1.67; 5.285; 5.565",
"StrengthUnit": "kg/50kg; kg/50kg; kg/50kg; kg/50kg; kg/50kg; kg/50kg; kg/50kg; kg/50kg; kg/50kg; kg/50kg; kg/50kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "18-NOV-87"
},
{
"NDCCode": "12634-537-00",
"PackageDescription": "10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (12634-537-00)",
"NDC11Code": "12634-0537-00",
"ProductNDC": "12634-537",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"NonProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074119",
"LabelerName": "Apotheca, Inc.",
"SubstanceName": "PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN",
"StrengthNumber": "100; 650",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"Description": "Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone."
},
{
"NDCCode": "12634-537-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (12634-537-01)",
"NDC11Code": "12634-0537-01",
"ProductNDC": "12634-537",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"NonProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074119",
"LabelerName": "Apotheca, Inc.",
"SubstanceName": "PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN",
"StrengthNumber": "100; 650",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"Description": "Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone."
},
{
"NDCCode": "12634-537-55",
"PackageDescription": "15 TABLET, FILM COATED in 1 BLISTER PACK (12634-537-55)",
"NDC11Code": "12634-0537-55",
"ProductNDC": "12634-537",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"NonProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074119",
"LabelerName": "Apotheca, Inc.",
"SubstanceName": "PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN",
"StrengthNumber": "100; 650",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"Description": "Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone."
},
{
"NDCCode": "12634-537-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (12634-537-60)",
"NDC11Code": "12634-0537-60",
"ProductNDC": "12634-537",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"NonProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074119",
"LabelerName": "Apotheca, Inc.",
"SubstanceName": "PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN",
"StrengthNumber": "100; 650",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"Description": "Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone."
},
{
"NDCCode": "12634-537-69",
"PackageDescription": "9 TABLET, FILM COATED in 1 BLISTER PACK (12634-537-69)",
"NDC11Code": "12634-0537-69",
"ProductNDC": "12634-537",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"NonProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074119",
"LabelerName": "Apotheca, Inc.",
"SubstanceName": "PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN",
"StrengthNumber": "100; 650",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"Description": "Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone."
},
{
"NDCCode": "12634-537-71",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (12634-537-71)",
"NDC11Code": "12634-0537-71",
"ProductNDC": "12634-537",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"NonProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074119",
"LabelerName": "Apotheca, Inc.",
"SubstanceName": "PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN",
"StrengthNumber": "100; 650",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"Description": "Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone."
},
{
"NDCCode": "12634-537-80",
"PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (12634-537-80)",
"NDC11Code": "12634-0537-80",
"ProductNDC": "12634-537",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"NonProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074119",
"LabelerName": "Apotheca, Inc.",
"SubstanceName": "PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN",
"StrengthNumber": "100; 650",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"Description": "Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone."
},
{
"NDCCode": "12634-537-82",
"PackageDescription": "12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (12634-537-82)",
"NDC11Code": "12634-0537-82",
"ProductNDC": "12634-537",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"NonProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074119",
"LabelerName": "Apotheca, Inc.",
"SubstanceName": "PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN",
"StrengthNumber": "100; 650",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"Description": "Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone."
},
{
"NDCCode": "12634-537-85",
"PackageDescription": "15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (12634-537-85)",
"NDC11Code": "12634-0537-85",
"ProductNDC": "12634-537",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"NonProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074119",
"LabelerName": "Apotheca, Inc.",
"SubstanceName": "PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN",
"StrengthNumber": "100; 650",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"Description": "Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone."
},
{
"NDCCode": "12634-537-91",
"PackageDescription": "1 TABLET, FILM COATED in 1 BLISTER PACK (12634-537-91)",
"NDC11Code": "12634-0537-91",
"ProductNDC": "12634-537",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"NonProprietaryName": "Propoxyphene Napsylate And Acetaminophen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074119",
"LabelerName": "Apotheca, Inc.",
"SubstanceName": "PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN",
"StrengthNumber": "100; 650",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"Description": "Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone."
}
]
}
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<NDC>
<NDCCode>41520-565-46</NDCCode>
<PackageDescription>130 g in 1 CAN (41520-565-46) </PackageDescription>
<NDC11Code>41520-0565-46</NDC11Code>
<ProductNDC>41520-565</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Miconazole Nitrate</ProprietaryName>
<NonProprietaryName>Anti-fungal Miconazole Athletes Foot Spray Talc Free</NonProprietaryName>
<DosageFormName>AEROSOL, POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20171020</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M005</ApplicationNumber>
<LabelerName>Foodhold USA</LabelerName>
<SubstanceName>MICONAZOLE NITRATE</SubstanceName>
<StrengthNumber>2.6</StrengthNumber>
<StrengthUnit>g/130g</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171020</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>cures most athlete's foot (linea pedis), ringworm (linea corporis) and jock itch (linea cruris). relieves symptoms of athlete's foot, including itching burning and cracking.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>41520-087-46</NDCCode>
<PackageDescription>131 g in 1 CAN (41520-087-46) </PackageDescription>
<NDC11Code>41520-0087-46</NDC11Code>
<ProductNDC>41520-087</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Miconazole Nitrate</ProprietaryName>
<NonProprietaryName>Jock Itch Spray</NonProprietaryName>
<DosageFormName>AEROSOL, SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20171219</StartMarketingDate>
<EndMarketingDate>20200302</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333C</ApplicationNumber>
<LabelerName>Foodhold USA</LabelerName>
<SubstanceName>MICONAZOLE NITRATE</SubstanceName>
<StrengthNumber>1.3</StrengthNumber>
<StrengthUnit>g/131g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-03-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20171219</StartMarketingDatePackage>
<EndMarketingDatePackage>20200302</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>41520-088-46</NDCCode>
<PackageDescription>130 g in 1 CAN (41520-088-46) </PackageDescription>
<NDC11Code>41520-0088-46</NDC11Code>
<ProductNDC>41520-088</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Miconazole Nitrate</ProprietaryName>
<NonProprietaryName>Miconazole Nitrate Antifungal Powder Spray</NonProprietaryName>
<DosageFormName>AEROSOL, SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120103</StartMarketingDate>
<EndMarketingDate>20200312</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333C</ApplicationNumber>
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<SubstanceName>MICONAZOLE NITRATE</SubstanceName>
<StrengthNumber>2.6</StrengthNumber>
<StrengthUnit>g/130g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-03-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20120103</StartMarketingDatePackage>
<EndMarketingDatePackage>20200312</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>41520-566-46</NDCCode>
<PackageDescription>130 g in 1 CAN (41520-566-46) </PackageDescription>
<NDC11Code>41520-0566-46</NDC11Code>
<ProductNDC>41520-566</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Miconazole Nitrate</ProprietaryName>
<NonProprietaryName>Jock Itch Spray Talc Free</NonProprietaryName>
<DosageFormName>AEROSOL, SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20171020</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M005</ApplicationNumber>
<LabelerName>American Sales Company</LabelerName>
<SubstanceName>MICONAZOLE NITRATE</SubstanceName>
<StrengthNumber>1.3</StrengthNumber>
<StrengthUnit>g/130g</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171020</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>cures most jock itch (tinea cruris). relieves symptoms of jock itch including itching, burning and chafing associated with jock itch.</IndicationAndUsage>
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<NDC>
<NDCCode>41520-612-46</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (41520-612-46) / 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>41520-0612-46</NDC11Code>
<ProductNDC>41520-612</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Careone Allergy Relief</ProprietaryName>
<ProprietaryNameSuffix>24 Hour</ProprietaryNameSuffix>
<NonProprietaryName>Loratadine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060602</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076301</ApplicationNumber>
<LabelerName>American Sales Company</LabelerName>
<SubstanceName>LORATADINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060602</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 itchy, watery eyes, 3 sneezing, 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>65162-316-84</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (65162-316-84) > 1 KIT in 1 BLISTER PACK (65162-316-58)</PackageDescription>
<NDC11Code>65162-0316-84</NDC11Code>
<ProductNDC>65162-316</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lomedia 24 Fe</ProprietaryName>
<NonProprietaryName>Norethindrone Acetate And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078267</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York, LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Lomedia 24 Fe tablets are 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 2 lists the typical unplanned pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant®* system, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. TABLE 2Percentage of women experiencing an unintended pregnancy during the first year of typical use and the first year of perfect use of contraception and the percentage continuing use at the end of the first year. United States. Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces risk of pregnancy by at least 75%9. Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception. Source: Trussell J, Stewart F, Contraceptive Efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal 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 percentage of women becoming pregnant noted 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% became pregnant in one year. This estimate was lowered slightly (to 85%) to represent the percentage that would become pregnant within one year among women now relying on reversible methods of contraception if they abandon contraception altogether. 5 Foams, creams, gels, vaginal suppositories and vaginal film. 6 Cervical mucous (ovulation) method supplemented by calendar in the preovulatory and basal body temperature in the postovulatory phases. 7 With spermicidal cream or jelly. 8 Without spermicides. 9 The treatment schedule is one dose within 72 hours after unprotected intercourse and a second dose 12 hours after the first dose. The Food and Drug Administration has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral®* (1 dose is 2 white pills), Alesse®* (1 dose is 5 pink pills), Nordette®* or Levlen®* (1 dose is 2 light orange pills), Lo/Ovral®* (1 dose is 4 white pills), Triphasil®* or Tri-Levlen®* (1 dose is 4 yellow pills). 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 six months of age. Clinical Studies. In a clinical study, 743 women, 18 to 45 years of age, were treated with Lomedia24 Fe for up to six 28-day cycles providing a total of 3,823 treatment-cycles of exposure. A total of 583 women completed 6 cycles of treatment. There were a total of 5 on-treatment pregnancies in 3,565 treatment cycles during which no backup contraception was used. The Pearl Index for Lomedia24 Fe was 1.82.</IndicationAndUsage>
<Description>Lomedia® 24 Fe provides a dosage regimen consisting of 24 white progestogen-estrogen contraceptive tablets and 4 brown ferrous fumarate (placebo) tablets. Each white tablet contains 1 mg norethindrone acetate and 20 mcg ethinyl estradiol. Each white tablet also contains the following inactive ingredients: povidone, anhydrous lactose, microcrystalline cellulose, polacrilin potassium and magnesium stearate. Each brown tablet contains ferrous fumarate, pregelatinized starch, anhydrous lactose, crospovidone, magnesium stearate. The ferrous fumarate tablets do not serve any therapeutic purpose. Ethinyl Estradiol has a molecular weight of 296.40 and a molecular formula of C20H24O2. Norethindrone Acetate has a molecular weight of 340.46 and a molecular formula of C22H28O3. The structural formulas for the active hormones are. Ethinyl Estradiol [19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-]. Norethindrone Acetate [19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17α)-].</Description>
</NDC>
<NDC>
<NDCCode>41520-161-08</NDCCode>
<PackageDescription>221 mL in 1 BOTTLE, PUMP (41520-161-08)</PackageDescription>
<NDC11Code>41520-0161-08</NDC11Code>
<ProductNDC>41520-161</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antibacterial Foaming</ProprietaryName>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110516</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>AMERICAN SALES COMPANY</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>.46</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For hand washing to decrease bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>41520-165-08</NDCCode>
<PackageDescription>221 mL in 1 BOTTLE, PUMP (41520-165-08)</PackageDescription>
<NDC11Code>41520-0165-08</NDC11Code>
<ProductNDC>41520-165</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antibacterial Foaming</ProprietaryName>
<ProprietaryNameSuffix>Green Tea</ProprietaryNameSuffix>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110516</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>AMERICAN SALES COMPANY</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>.46</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For hand washing to decrease bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>41520-169-08</NDCCode>
<PackageDescription>221 mL in 1 BOTTLE, PUMP (41520-169-08)</PackageDescription>
<NDC11Code>41520-0169-08</NDC11Code>
<ProductNDC>41520-169</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antibacterial Foaming</ProprietaryName>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110516</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>AMERICAN SALES COMPANY</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>.46</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For hand washing to decrease bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0143-9558-01</NDCCode>
<PackageDescription>1 VIAL in 1 BOX (0143-9558-01) > 5 mL in 1 VIAL</PackageDescription>
<NDC11Code>00143-9558-01</NDC11Code>
<ProductNDC>0143-9558</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levoleucovorin</ProprietaryName>
<NonProprietaryName>Levoleucovorin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20160707</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206263</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>LEVOLEUCOVORIN CALCIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Folate Analog [EPC], Folic Acid [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160707</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levoleucovorin for Injection is indicated for: 1 rescue after high-dose methotrexate therapy in adult and pediatric patients with osteosarcoma., 2 diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination in adult and pediatric patients., 3 the treatment of adults with metastatic colorectal cancer in combination with fluorouracil. .</IndicationAndUsage>
<Description>Levoleucovorin is a folate analog and the pharmacologically active levo-isomer of d,l-leucovorin. The chemical name of levoleucovorin calcium is Calcium N-[p-[[[(6S)-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6- pteridinyl]methyl]amino]benzoyl]-L-glutamate (1:1) mixed hydrate. The molecular formula is C20H21CaN7O7 .nH2O (n = 3 to 6) and the molecular weight is 565.6 to 619.6. The molecular structure is. Levoleucovorin for Injection, for intravenous use is supplied as a sterile white to pale yellow lyophilized powder consisting of 50 mg levoleucovorin (equivalent to 64 mg levoleucovorin calcium mixed hydrate) and 50 mg mannitol per 50 mg single dose vial. Sodium hydroxide and/or hydrochloric acid are used to adjust the pH.</Description>
</NDC>
<NDC>
<NDCCode>0228-4270-11</NDCCode>
<PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0228-4270-11) </PackageDescription>
<NDC11Code>00228-4270-11</NDC11Code>
<ProductNDC>0228-4270</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Morphine Sulfate</ProprietaryName>
<NonProprietaryName>Morphine Sulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151026</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203849</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>MORPHINE SULFATE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151026</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Morphine sulfate extended-release tablets are indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations [see Warnings and Precautions (5.1)], reserve morphine sulfate extended-release for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Morphine sulfate extended-release tablets are not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
<Description>Morphine sulfate extended-release tablets are for oral use and contain morphine sulfate, USP an opioid agonist. Each tablet contains the following inactive ingredients common to all strengths: anhydrous lactose, cetostearyl alcohol, hydroxyethyl cellulose, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. The 30 mg tablets also contain yellow iron oxide. The 60 mg tablets also contain red iron oxide. The 100 mg and 200 mg tablets also contain red iron oxide and yellow iron oxide. The tablet strengths, 15 mg, 30 mg, 60 mg, 100 mg, and 200 mg, describe the amount of morphine per tablet as the pentahydrated sulfate salt (morphine sulfate). Morphine sulfate, USP is an odorless, white, crystalline powder with a bitter taste. Morphine sulfate, USP is soluble in water and ethanol. 1 g dissolves in 15.5 mL of water at 25°C and 1 g dissolves in 565 mL of ethanol at 25°C. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its molecular weight is 758.83 and its structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>0228-4311-11</NDCCode>
<PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0228-4311-11) </PackageDescription>
<NDC11Code>00228-4311-11</NDC11Code>
<ProductNDC>0228-4311</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Morphine Sulfate</ProprietaryName>
<NonProprietaryName>Morphine Sulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151026</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203849</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>MORPHINE SULFATE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151026</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Morphine sulfate extended-release tablets are indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations [see Warnings and Precautions (5.1)], reserve morphine sulfate extended-release for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Morphine sulfate extended-release tablets are not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
<Description>Morphine sulfate extended-release tablets are for oral use and contain morphine sulfate, USP an opioid agonist. Each tablet contains the following inactive ingredients common to all strengths: anhydrous lactose, cetostearyl alcohol, hydroxyethyl cellulose, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. The 30 mg tablets also contain yellow iron oxide. The 60 mg tablets also contain red iron oxide. The 100 mg and 200 mg tablets also contain red iron oxide and yellow iron oxide. The tablet strengths, 15 mg, 30 mg, 60 mg, 100 mg, and 200 mg, describe the amount of morphine per tablet as the pentahydrated sulfate salt (morphine sulfate). Morphine sulfate, USP is an odorless, white, crystalline powder with a bitter taste. Morphine sulfate, USP is soluble in water and ethanol. 1 g dissolves in 15.5 mL of water at 25°C and 1 g dissolves in 565 mL of ethanol at 25°C. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its molecular weight is 758.83 and its structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>0228-4323-11</NDCCode>
<PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0228-4323-11) </PackageDescription>
<NDC11Code>00228-4323-11</NDC11Code>
<ProductNDC>0228-4323</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Morphine Sulfate</ProprietaryName>
<NonProprietaryName>Morphine Sulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151026</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203849</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>MORPHINE SULFATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151026</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Morphine sulfate extended-release tablets are indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations [see Warnings and Precautions (5.1)], reserve morphine sulfate extended-release for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Morphine sulfate extended-release tablets are not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
<Description>Morphine sulfate extended-release tablets are for oral use and contain morphine sulfate, USP an opioid agonist. Each tablet contains the following inactive ingredients common to all strengths: anhydrous lactose, cetostearyl alcohol, hydroxyethyl cellulose, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. The 30 mg tablets also contain yellow iron oxide. The 60 mg tablets also contain red iron oxide. The 100 mg and 200 mg tablets also contain red iron oxide and yellow iron oxide. The tablet strengths, 15 mg, 30 mg, 60 mg, 100 mg, and 200 mg, describe the amount of morphine per tablet as the pentahydrated sulfate salt (morphine sulfate). Morphine sulfate, USP is an odorless, white, crystalline powder with a bitter taste. Morphine sulfate, USP is soluble in water and ethanol. 1 g dissolves in 15.5 mL of water at 25°C and 1 g dissolves in 565 mL of ethanol at 25°C. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its molecular weight is 758.83 and its structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>0228-4347-11</NDCCode>
<PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0228-4347-11) </PackageDescription>
<NDC11Code>00228-4347-11</NDC11Code>
<ProductNDC>0228-4347</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Morphine Sulfate</ProprietaryName>
<NonProprietaryName>Morphine Sulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151026</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203849</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>MORPHINE SULFATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151026</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Morphine sulfate extended-release tablets are indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations [see Warnings and Precautions (5.1)], reserve morphine sulfate extended-release for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Morphine sulfate extended-release tablets are not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
<Description>Morphine sulfate extended-release tablets are for oral use and contain morphine sulfate, USP an opioid agonist. Each tablet contains the following inactive ingredients common to all strengths: anhydrous lactose, cetostearyl alcohol, hydroxyethyl cellulose, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. The 30 mg tablets also contain yellow iron oxide. The 60 mg tablets also contain red iron oxide. The 100 mg and 200 mg tablets also contain red iron oxide and yellow iron oxide. The tablet strengths, 15 mg, 30 mg, 60 mg, 100 mg, and 200 mg, describe the amount of morphine per tablet as the pentahydrated sulfate salt (morphine sulfate). Morphine sulfate, USP is an odorless, white, crystalline powder with a bitter taste. Morphine sulfate, USP is soluble in water and ethanol. 1 g dissolves in 15.5 mL of water at 25°C and 1 g dissolves in 565 mL of ethanol at 25°C. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its molecular weight is 758.83 and its structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>0406-0187-33</NDCCode>
<PackageDescription>565 kg in 1 SUPERSACK (0406-0187-33)</PackageDescription>
<NDC11Code>00406-0187-33</NDC11Code>
<ProductNDC>0406-0187</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>P-aminophenol</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20130219</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Mallinckrodt, Inc.</LabelerName>
<SubstanceName>P-AMINOPHENOL</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0406-0960-34</NDCCode>
<PackageDescription>565 kg in 1 SUPERSACK (0406-0960-34) </PackageDescription>
<NDC11Code>00406-0960-34</NDC11Code>
<ProductNDC>0406-0960</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Acetaminophen Anhydrous Basis</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>19821220</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>SpecGx LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>.9</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-07-27</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20-DEC-82</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>10356-565-16</NDCCode>
<PackageDescription>75 mL in 1 TUBE (10356-565-16)</PackageDescription>
<NDC11Code>10356-0565-16</NDC11Code>
<ProductNDC>10356-565</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nivea For Men Protective</ProprietaryName>
<NonProprietaryName>Octinoxate, Avobenzone, Oxybenzone</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120615</StartMarketingDate>
<EndMarketingDate>20171231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Beiersdorf Inc</LabelerName>
<SubstanceName>OCTINOXATE; AVOBENZONE; OXYBENZONE</SubstanceName>
<StrengthNumber>6; 2; 2</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-01-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>10544-565-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10544-565-30)</PackageDescription>
<NDC11Code>10544-0565-30</NDC11Code>
<ProductNDC>10544-565</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride</ProprietaryName>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131113</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA018279</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS, OR FOR PATIENTS WITH WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS. : 1 1.For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication, and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia., 2 2.For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias.</IndicationAndUsage>
<Description>Potassium chloride extended-release tablets is a solid oral dosage form of potassium chloride containing 8 mEq, 10 mEq and 20 mEq of potassium chloride, USP, equivalent to 600 mg, 750 mg and 1500 mg of potassium, respectively, in a film-coated (not enteric-coated), wax matrix tablet. These formulations are intended to slow the release of potassium so that the likelihood of a high localized concentration of potassium chloride within the gastrointestinal tract is reduced. The expended inert, porous, wax/polymer matrix is not absorbed and may be excreted intact in the stool. Potassium chloride extended-release tablets are an electrolyte replenisher. The chemical name is potassium chloride, and the structural formula is KCl. Potassium chloride, USP, occurs as a white, granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol.</Description>
</NDC>
<NDC>
<NDCCode>10544-565-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10544-565-90)</PackageDescription>
<NDC11Code>10544-0565-90</NDC11Code>
<ProductNDC>10544-565</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride</ProprietaryName>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131113</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA018279</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS, OR FOR PATIENTS WITH WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS. : 1 1.For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication, and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia., 2 2.For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias.</IndicationAndUsage>
<Description>Potassium chloride extended-release tablets is a solid oral dosage form of potassium chloride containing 8 mEq, 10 mEq and 20 mEq of potassium chloride, USP, equivalent to 600 mg, 750 mg and 1500 mg of potassium, respectively, in a film-coated (not enteric-coated), wax matrix tablet. These formulations are intended to slow the release of potassium so that the likelihood of a high localized concentration of potassium chloride within the gastrointestinal tract is reduced. The expended inert, porous, wax/polymer matrix is not absorbed and may be excreted intact in the stool. Potassium chloride extended-release tablets are an electrolyte replenisher. The chemical name is potassium chloride, and the structural formula is KCl. Potassium chloride, USP, occurs as a white, granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol.</Description>
</NDC>
<NDC>
<NDCCode>12497-1042-1</NDCCode>
<PackageDescription>1 BAG in 1 DRUM (12497-1042-1) > 50 kg in 1 BAG</PackageDescription>
<NDC11Code>12497-1042-01</NDC11Code>
<ProductNDC>12497-1042</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Amino Acid Mixture Ko80</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>19871118</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Kyowa Hakko Bio Co., Ltd.</LabelerName>
<SubstanceName>THREONINE; METHIONINE; SERINE; ISOLEUCINE; LEUCINE; GLYCINE; VALINE; ARGININE; HISTIDINE; ALANINE; PROLINE</SubstanceName>
<StrengthNumber>3.125; .695; 3.475; 6.26; 7.65; 6.26; 5.84; 4.17; 1.67; 5.285; 5.565</StrengthNumber>
<StrengthUnit>kg/50kg; kg/50kg; kg/50kg; kg/50kg; kg/50kg; kg/50kg; kg/50kg; kg/50kg; kg/50kg; kg/50kg; kg/50kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>18-NOV-87</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>12634-537-00</NDCCode>
<PackageDescription>10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (12634-537-00)</PackageDescription>
<NDC11Code>12634-0537-00</NDC11Code>
<ProductNDC>12634-537</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propoxyphene Napsylate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Propoxyphene Napsylate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074119</ApplicationNumber>
<LabelerName>Apotheca, Inc.</LabelerName>
<SubstanceName>PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>100; 650</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<Description>Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone.</Description>
</NDC>
<NDC>
<NDCCode>12634-537-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (12634-537-01)</PackageDescription>
<NDC11Code>12634-0537-01</NDC11Code>
<ProductNDC>12634-537</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propoxyphene Napsylate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Propoxyphene Napsylate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074119</ApplicationNumber>
<LabelerName>Apotheca, Inc.</LabelerName>
<SubstanceName>PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>100; 650</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<Description>Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone.</Description>
</NDC>
<NDC>
<NDCCode>12634-537-55</NDCCode>
<PackageDescription>15 TABLET, FILM COATED in 1 BLISTER PACK (12634-537-55)</PackageDescription>
<NDC11Code>12634-0537-55</NDC11Code>
<ProductNDC>12634-537</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propoxyphene Napsylate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Propoxyphene Napsylate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074119</ApplicationNumber>
<LabelerName>Apotheca, Inc.</LabelerName>
<SubstanceName>PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>100; 650</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<Description>Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone.</Description>
</NDC>
<NDC>
<NDCCode>12634-537-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (12634-537-60)</PackageDescription>
<NDC11Code>12634-0537-60</NDC11Code>
<ProductNDC>12634-537</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propoxyphene Napsylate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Propoxyphene Napsylate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074119</ApplicationNumber>
<LabelerName>Apotheca, Inc.</LabelerName>
<SubstanceName>PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>100; 650</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<Description>Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone.</Description>
</NDC>
<NDC>
<NDCCode>12634-537-69</NDCCode>
<PackageDescription>9 TABLET, FILM COATED in 1 BLISTER PACK (12634-537-69)</PackageDescription>
<NDC11Code>12634-0537-69</NDC11Code>
<ProductNDC>12634-537</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propoxyphene Napsylate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Propoxyphene Napsylate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074119</ApplicationNumber>
<LabelerName>Apotheca, Inc.</LabelerName>
<SubstanceName>PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>100; 650</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<Description>Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone.</Description>
</NDC>
<NDC>
<NDCCode>12634-537-71</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (12634-537-71)</PackageDescription>
<NDC11Code>12634-0537-71</NDC11Code>
<ProductNDC>12634-537</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propoxyphene Napsylate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Propoxyphene Napsylate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074119</ApplicationNumber>
<LabelerName>Apotheca, Inc.</LabelerName>
<SubstanceName>PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>100; 650</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<Description>Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone.</Description>
</NDC>
<NDC>
<NDCCode>12634-537-80</NDCCode>
<PackageDescription>20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (12634-537-80)</PackageDescription>
<NDC11Code>12634-0537-80</NDC11Code>
<ProductNDC>12634-537</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propoxyphene Napsylate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Propoxyphene Napsylate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074119</ApplicationNumber>
<LabelerName>Apotheca, Inc.</LabelerName>
<SubstanceName>PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>100; 650</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<Description>Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone.</Description>
</NDC>
<NDC>
<NDCCode>12634-537-82</NDCCode>
<PackageDescription>12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (12634-537-82)</PackageDescription>
<NDC11Code>12634-0537-82</NDC11Code>
<ProductNDC>12634-537</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propoxyphene Napsylate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Propoxyphene Napsylate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074119</ApplicationNumber>
<LabelerName>Apotheca, Inc.</LabelerName>
<SubstanceName>PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>100; 650</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<Description>Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone.</Description>
</NDC>
<NDC>
<NDCCode>12634-537-85</NDCCode>
<PackageDescription>15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (12634-537-85)</PackageDescription>
<NDC11Code>12634-0537-85</NDC11Code>
<ProductNDC>12634-537</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propoxyphene Napsylate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Propoxyphene Napsylate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074119</ApplicationNumber>
<LabelerName>Apotheca, Inc.</LabelerName>
<SubstanceName>PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>100; 650</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<Description>Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone.</Description>
</NDC>
<NDC>
<NDCCode>12634-537-91</NDCCode>
<PackageDescription>1 TABLET, FILM COATED in 1 BLISTER PACK (12634-537-91)</PackageDescription>
<NDC11Code>12634-0537-91</NDC11Code>
<ProductNDC>12634-537</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propoxyphene Napsylate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Propoxyphene Napsylate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074119</ApplicationNumber>
<LabelerName>Apotheca, Inc.</LabelerName>
<SubstanceName>PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>100; 650</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<Description>Propoxyphene napsylate and acetaminophen tablets USP contain propoxyphene napsylate and acetaminophen. Propoxyphene napsylate is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water, soluble in methanol, in ethanol, in chloroform, and in acetone. Chemically it is (αS,1R)-α-[2-(dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate and can be represented by the following structural formula. C22H29NO2C10H8O3SH2O M.W. 565.74. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Chemically, it is acetamide, N-(4-hydroxyphenyl)- and can structurally be represented by the following. C8H9NO2 M.W. 151.16. Each pink tablet of propoxyphene napsylate and acetaminophen tablets contains 100 mg propoxyphene napsylate and 650 mg acetaminophen. Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/650 mg (PINK) contain the following inactive ingredients. colloidal silicon dioxide,D and C red No 27 aluminum lake, D and C yellow No 10 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide, and crospovidone.</Description>
</NDC>
</NDCList>