{
"NDC": [
{
"NDCCode": "0378-5630-59",
"PackageDescription": "9 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5630-59) ",
"NDC11Code": "00378-5630-59",
"ProductNDC": "0378-5630",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sumatriptan Succinate",
"NonProprietaryName": "Sumatriptan Succinate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090810",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077744",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "SUMATRIPTAN SUCCINATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090810",
"SamplePackage": "N",
"IndicationAndUsage": "Sumatriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan tablets, reconsider the diagnosis of migraine before sumatriptan tablets are administered to treat any subsequent attacks., 2 Sumatriptan tablets are not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of sumatriptan tablets have not been established for cluster headache.",
"Description": "Sumatriptan tablets, USP contain sumatriptan succinate, a selective 5-HT1B/1D receptor agonist. Sumatriptan succinate is chemically designated as 3-[2-(Dimethylamino)ethyl]-N-methylindole-5-methanesulfonamide succinate (1:1), and it has the following structure. The empirical formula is C14H21N3O2SC4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate, USP is a white to off-white powder that is readily soluble in water and in saline. Each sumatriptan tablet for oral administration contains 35, 70, or 140 mg of sumatriptan succinate, USP equivalent to 25, 50, or 100 mg of sumatriptan, respectively. Each tablet also contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium lauryl sulfate, titanium dioxide and triacetin. Meets USP Dissolution Test 2."
},
{
"NDCCode": "0378-5630-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5630-01)",
"NDC11Code": "00378-5630-01",
"ProductNDC": "0378-5630",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sumatriptan Succinate",
"NonProprietaryName": "Sumatriptan Succinate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090810",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077744",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "SUMATRIPTAN SUCCINATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2015-07-17"
},
{
"NDCCode": "0378-5630-11",
"PackageDescription": "150000000 TABLET, FILM COATED in 1 DRUM (0378-5630-11) ",
"NDC11Code": "00378-5630-11",
"ProductNDC": "0378-5630",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Sumatriptan Succinate",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20090810",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "SUMATRIPTAN SUCCINATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2024-04-11",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "10-AUG-09"
},
{
"NDCCode": "0378-3701-59",
"PackageDescription": "9 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0378-3701-59) ",
"NDC11Code": "00378-3701-59",
"ProductNDC": "0378-3701",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rizatriptan Benzoate",
"NonProprietaryName": "Rizatriptan Benzoate",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20121231",
"EndMarketingDate": "20200331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078173",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "RIZATRIPTAN BENZOATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20121231",
"EndMarketingDatePackage": "20200331",
"SamplePackage": "N"
},
{
"NDCCode": "0378-3702-59",
"PackageDescription": "9 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0378-3702-59) ",
"NDC11Code": "00378-3702-59",
"ProductNDC": "0378-3702",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rizatriptan Benzoate",
"NonProprietaryName": "Rizatriptan Benzoate",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20121231",
"EndMarketingDate": "20200331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078173",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "RIZATRIPTAN BENZOATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20121231",
"EndMarketingDatePackage": "20200331",
"SamplePackage": "N"
},
{
"NDCCode": "0378-4260-59",
"PackageDescription": "9 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4260-59)",
"NDC11Code": "00378-4260-59",
"ProductNDC": "0378-4260",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zolmitriptan",
"NonProprietaryName": "Zolmitriptan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203186",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "ZOLMITRIPTAN",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "0378-4261-59",
"PackageDescription": "9 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4261-59)",
"NDC11Code": "00378-4261-59",
"ProductNDC": "0378-4261",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zolmitriptan",
"NonProprietaryName": "Zolmitriptan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203186",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "ZOLMITRIPTAN",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "0378-4450-59",
"PackageDescription": "9 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4450-59)",
"NDC11Code": "00378-4450-59",
"ProductNDC": "0378-4450",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naratriptan",
"NonProprietaryName": "Naratriptan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120613",
"EndMarketingDate": "20170930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202431",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "NARATRIPTAN HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-10-03"
},
{
"NDCCode": "0378-4451-59",
"PackageDescription": "9 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4451-59)",
"NDC11Code": "00378-4451-59",
"ProductNDC": "0378-4451",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naratriptan",
"NonProprietaryName": "Naratriptan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120613",
"EndMarketingDate": "20170731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202431",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "NARATRIPTAN HYDROCHLORIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-08-02"
},
{
"NDCCode": "0378-5631-59",
"PackageDescription": "9 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5631-59) ",
"NDC11Code": "00378-5631-59",
"ProductNDC": "0378-5631",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sumatriptan Succinate",
"NonProprietaryName": "Sumatriptan Succinate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090810",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077744",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "SUMATRIPTAN SUCCINATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090810",
"SamplePackage": "N",
"IndicationAndUsage": "Sumatriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan tablets, reconsider the diagnosis of migraine before sumatriptan tablets are administered to treat any subsequent attacks., 2 Sumatriptan tablets are not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of sumatriptan tablets have not been established for cluster headache.",
"Description": "Sumatriptan tablets, USP contain sumatriptan succinate, a selective 5-HT1B/1D receptor agonist. Sumatriptan succinate is chemically designated as 3-[2-(Dimethylamino)ethyl]-N-methylindole-5-methanesulfonamide succinate (1:1), and it has the following structure. The empirical formula is C14H21N3O2SC4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate, USP is a white to off-white powder that is readily soluble in water and in saline. Each sumatriptan tablet for oral administration contains 35, 70, or 140 mg of sumatriptan succinate, USP equivalent to 25, 50, or 100 mg of sumatriptan, respectively. Each tablet also contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium lauryl sulfate, titanium dioxide and triacetin. Meets USP Dissolution Test 2."
},
{
"NDCCode": "0378-5632-59",
"PackageDescription": "9 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5632-59) ",
"NDC11Code": "00378-5632-59",
"ProductNDC": "0378-5632",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sumatriptan Succinate",
"NonProprietaryName": "Sumatriptan Succinate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090810",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077744",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "SUMATRIPTAN SUCCINATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090810",
"SamplePackage": "N",
"IndicationAndUsage": "Sumatriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan tablets, reconsider the diagnosis of migraine before sumatriptan tablets are administered to treat any subsequent attacks., 2 Sumatriptan tablets are not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of sumatriptan tablets have not been established for cluster headache.",
"Description": "Sumatriptan tablets, USP contain sumatriptan succinate, a selective 5-HT1B/1D receptor agonist. Sumatriptan succinate is chemically designated as 3-[2-(Dimethylamino)ethyl]-N-methylindole-5-methanesulfonamide succinate (1:1), and it has the following structure. The empirical formula is C14H21N3O2SC4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate, USP is a white to off-white powder that is readily soluble in water and in saline. Each sumatriptan tablet for oral administration contains 35, 70, or 140 mg of sumatriptan succinate, USP equivalent to 25, 50, or 100 mg of sumatriptan, respectively. Each tablet also contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium lauryl sulfate, titanium dioxide and triacetin. Meets USP Dissolution Test 2."
},
{
"NDCCode": "0378-7303-53",
"PackageDescription": "3 POUCH in 1 CARTON (0378-7303-53) / 1 BLISTER PACK in 1 POUCH (0378-7303-85) / 1 KIT in 1 BLISTER PACK * 7 TABLET in 1 BLISTER PACK (0378-7191-71) * 9 TABLET in 1 BLISTER PACK (0378-7192-59) * 7 TABLET in 1 BLISTER PACK (0378-7193-71) * 5 TABLET in 1 BLISTER PACK (0378-7190-98) ",
"NDC11Code": "00378-7303-53",
"ProductNDC": "0378-7303",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate",
"NonProprietaryName": "Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate",
"DosageFormName": "KIT",
"StartMarketingDate": "20220727",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205069",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"Status": "Active",
"LastUpdate": "2025-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220727",
"SamplePackage": "N",
"IndicationAndUsage": "Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets are indicated for the prevention of pregnancy in women who elect to use combined oral contraceptives as a method of contraception. Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets are indicated for the treatment of moderate acne vulgaris in females, ≥ 15 years of age, who have no known contraindications to combined oral contraceptive therapy, desire oral contraception, have achieved menarche, and are unresponsive to topical anti-acne medications. Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets should be used for the treatment of acne only if the patient desires a combined oral contraceptive for birth control and plans to stay on it for at least 6 months. Combined oral contraceptives are highly effective for pregnancy prevention. Table 2 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. ¶ Foams, creams, gels, vaginal suppositories, and vaginal film. : 1 #Þ Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.",
"Description": "Norethindrone acetate and ethinyl estradiol tablets are graduated estrophasic combined oral contraceptive providing estrogen in a graduated sequence over a 21-day period with a constant dose of progestogen. Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets provide for a continuous dosage regimen consisting of 21 oral contraceptive tablets and seven ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose. Each white to off white tablet contains 1 mg norethindrone acetate [(17 alpha)- 17-(acetyloxy)-19-norpregna-4-en-20-yn-3-one] and 20 mcg ethinyl estradiol [(17 alpha)- 19-norpregna-1,3,5(10)-trien-20-yne-3,17-diol]; each light purple tablet contains 1 mg norethindrone acetate and 30 mcg ethinyl estradiol; and each purple tablet contains 1 mg norethindrone acetate, 35 mcg ethinyl estradiol. Norethindrone acetate and ethinyl estradiol tablets (1 mg and 20 mcg) also contain. Lactose anhydrous, lactose monohydrate, povidone K-25, dl-α-tocopherol, magnesium stearate, microcrystalline cellulose, croscarmellose sodium. Norethindrone acetate and ethinyl estradiol tablets (1 mg and 30 mcg) also contain. Lactose anhydrous, lactose monohydrate, povidone K-25, dl-α-tocopherol, magnesium stearate, microcrystalline cellulose, croscarmellose sodium, aluminium lake of FD and C Blue No. 1, aluminium lake of FD and C Blue No. 2, caramine. Norethindrone acetate and ethinyl estradiol tablets (1 mg and 35 mcg) also contain. Lactose anhydrous, lactose monohydrate, povidone K-25, dl-α-tocopherol, magnesium stearate, microcrystalline cellulose, croscarmellose sodium, aluminium lake of FD and C Blue No. 1, aluminium lake of FD and C Blue No. 2, caramine. The structural formulas are as follows. Each brown tablet contains ferrous fumarate, microcrystalline cellulose, lactose monohydrate, polyvinyl pyrrolidone K-90, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate. Each norethindrone acetate and ethinyl estradiol tablet and ferrous fumarate tablet blister contains five white to off white tablets, seven light purple tablets, nine purple tablets, and seven brown tablets. These tablets are to be taken in the following order: one white to off white each day for five days, then light purple tablet each day for seven days, followed by one purple tablet each day for nine days, and then one brown tablet each day for seven days."
},
{
"NDCCode": "0378-8755-59",
"PackageDescription": "9 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-8755-59) ",
"NDC11Code": "00378-8755-59",
"ProductNDC": "0378-8755",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sumatriptan And Naproxen Sodium",
"NonProprietaryName": "Sumatriptan And Naproxen Sodium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180904",
"EndMarketingDate": "20211231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090872",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "SUMATRIPTAN SUCCINATE; NAPROXEN SODIUM",
"StrengthNumber": "85; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC],Serotonin 1b Receptor Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180904",
"EndMarketingDatePackage": "20211231",
"SamplePackage": "N"
},
{
"NDCCode": "58264-0378-2",
"PackageDescription": "59.14 mL in 1 BOTTLE, GLASS (58264-0378-2) ",
"NDC11Code": "58264-0378-02",
"ProductNDC": "58264-0378",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "G-15",
"NonProprietaryName": "Hawthorn Leaf With Flower",
"DosageFormName": "SOLUTION",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "19900101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "DNA Labs, Inc.",
"SubstanceName": "HAWTHORN LEAF WITH FLOWER",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/mL",
"Status": "Active",
"LastUpdate": "2025-01-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19900101",
"SamplePackage": "N",
"IndicationAndUsage": "Supports the heart; excessive weight."
},
{
"NDCCode": "0378-3813-01",
"PackageDescription": "100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0378-3813-01) ",
"NDC11Code": "00378-3813-01",
"ProductNDC": "0378-3813",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clozapine",
"NonProprietaryName": "Clozapine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20151102",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201824",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "CLOZAPINE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20151102",
"SamplePackage": "N",
"IndicationAndUsage": "Clozapine orally disintegrating tablets (Clozapine ODT) is an atypical antipsychotic indicated for: 1 Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, Clozapine ODT should be used only in patients who have failed to respond adequately to standard antipsychotic treatment (1.1), 2 Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior (1.2).",
"Description": "Clozapine, an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine. The structural formula is:. Clozapine Orally Disintegrating Tablets (referred to as Clozapine ODT) are available as peach, orally disintegrating tablets of 25 mg, 100 mg, 150 mg or 200 mg for oral administration without water. Clozapine orally disintegrating tablets may be chewed. Each orally disintegrating tablet contains clozapine, USP equivalent to 25 mg, 100 mg, 150 mg or 200 mg. The active component of clozapine orally disintegrating tablets is clozapine. The remaining components are aspartame, crospovidone, FD&C Yellow No. 6 Aluminum Lake, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, silicon dioxide and sodium stearyl fumarate. Clozapine ODT contains aspartame [see Warnings and Precautions (5.18)]. Phenylalanine is a component of aspartame. Each 25 mg, orally disintegrating tablet contains 3.38 mg aspartame, thus, 1.90 mg phenylalanine. Each 100 mg, orally disintegrating tablet contains 13.52 mg aspartame, thus, 7.59 mg phenylalanine. Each 150 mg, orally disintegrating tablet contains 20.28 mg aspartame, thus, 11.38 mg phenylalanine. Each 200 mg, orally disintegrating tablet contains 27.04 mg aspartame, thus, 15.18 mg phenylalanine."
},
{
"NDCCode": "0378-3815-01",
"PackageDescription": "100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0378-3815-01) ",
"NDC11Code": "00378-3815-01",
"ProductNDC": "0378-3815",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clozapine",
"NonProprietaryName": "Clozapine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20151102",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201824",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "CLOZAPINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20151102",
"SamplePackage": "N",
"IndicationAndUsage": "Clozapine orally disintegrating tablets (Clozapine ODT) is an atypical antipsychotic indicated for: 1 Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, Clozapine ODT should be used only in patients who have failed to respond adequately to standard antipsychotic treatment (1.1), 2 Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior (1.2).",
"Description": "Clozapine, an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine. The structural formula is:. Clozapine Orally Disintegrating Tablets (referred to as Clozapine ODT) are available as peach, orally disintegrating tablets of 25 mg, 100 mg, 150 mg or 200 mg for oral administration without water. Clozapine orally disintegrating tablets may be chewed. Each orally disintegrating tablet contains clozapine, USP equivalent to 25 mg, 100 mg, 150 mg or 200 mg. The active component of clozapine orally disintegrating tablets is clozapine. The remaining components are aspartame, crospovidone, FD&C Yellow No. 6 Aluminum Lake, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, silicon dioxide and sodium stearyl fumarate. Clozapine ODT contains aspartame [see Warnings and Precautions (5.18)]. Phenylalanine is a component of aspartame. Each 25 mg, orally disintegrating tablet contains 3.38 mg aspartame, thus, 1.90 mg phenylalanine. Each 100 mg, orally disintegrating tablet contains 13.52 mg aspartame, thus, 7.59 mg phenylalanine. Each 150 mg, orally disintegrating tablet contains 20.28 mg aspartame, thus, 11.38 mg phenylalanine. Each 200 mg, orally disintegrating tablet contains 27.04 mg aspartame, thus, 15.18 mg phenylalanine."
},
{
"NDCCode": "0378-3816-01",
"PackageDescription": "100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0378-3816-01) ",
"NDC11Code": "00378-3816-01",
"ProductNDC": "0378-3816",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clozapine",
"NonProprietaryName": "Clozapine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20230816",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201824",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "CLOZAPINE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230816",
"SamplePackage": "N",
"IndicationAndUsage": "Clozapine orally disintegrating tablets (Clozapine ODT) is an atypical antipsychotic indicated for: 1 Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, Clozapine ODT should be used only in patients who have failed to respond adequately to standard antipsychotic treatment (1.1), 2 Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior (1.2).",
"Description": "Clozapine, an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine. The structural formula is:. Clozapine Orally Disintegrating Tablets (referred to as Clozapine ODT) are available as peach, orally disintegrating tablets of 25 mg, 100 mg, 150 mg or 200 mg for oral administration without water. Clozapine orally disintegrating tablets may be chewed. Each orally disintegrating tablet contains clozapine, USP equivalent to 25 mg, 100 mg, 150 mg or 200 mg. The active component of clozapine orally disintegrating tablets is clozapine. The remaining components are aspartame, crospovidone, FD&C Yellow No. 6 Aluminum Lake, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, silicon dioxide and sodium stearyl fumarate. Clozapine ODT contains aspartame [see Warnings and Precautions (5.18)]. Phenylalanine is a component of aspartame. Each 25 mg, orally disintegrating tablet contains 3.38 mg aspartame, thus, 1.90 mg phenylalanine. Each 100 mg, orally disintegrating tablet contains 13.52 mg aspartame, thus, 7.59 mg phenylalanine. Each 150 mg, orally disintegrating tablet contains 20.28 mg aspartame, thus, 11.38 mg phenylalanine. Each 200 mg, orally disintegrating tablet contains 27.04 mg aspartame, thus, 15.18 mg phenylalanine."
},
{
"NDCCode": "0378-3817-01",
"PackageDescription": "100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0378-3817-01) ",
"NDC11Code": "00378-3817-01",
"ProductNDC": "0378-3817",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clozapine",
"NonProprietaryName": "Clozapine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20230816",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201824",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "CLOZAPINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230816",
"SamplePackage": "N",
"IndicationAndUsage": "Clozapine orally disintegrating tablets (Clozapine ODT) is an atypical antipsychotic indicated for: 1 Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, Clozapine ODT should be used only in patients who have failed to respond adequately to standard antipsychotic treatment (1.1), 2 Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior (1.2).",
"Description": "Clozapine, an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine. The structural formula is:. Clozapine Orally Disintegrating Tablets (referred to as Clozapine ODT) are available as peach, orally disintegrating tablets of 25 mg, 100 mg, 150 mg or 200 mg for oral administration without water. Clozapine orally disintegrating tablets may be chewed. Each orally disintegrating tablet contains clozapine, USP equivalent to 25 mg, 100 mg, 150 mg or 200 mg. The active component of clozapine orally disintegrating tablets is clozapine. The remaining components are aspartame, crospovidone, FD&C Yellow No. 6 Aluminum Lake, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, silicon dioxide and sodium stearyl fumarate. Clozapine ODT contains aspartame [see Warnings and Precautions (5.18)]. Phenylalanine is a component of aspartame. Each 25 mg, orally disintegrating tablet contains 3.38 mg aspartame, thus, 1.90 mg phenylalanine. Each 100 mg, orally disintegrating tablet contains 13.52 mg aspartame, thus, 7.59 mg phenylalanine. Each 150 mg, orally disintegrating tablet contains 20.28 mg aspartame, thus, 11.38 mg phenylalanine. Each 200 mg, orally disintegrating tablet contains 27.04 mg aspartame, thus, 15.18 mg phenylalanine."
},
{
"NDCCode": "42346-378-65",
"PackageDescription": "1 KIT in 1 KIT (42346-378-65) * 1 BOTTLE, DROPPER in 1 CARTON (42346-360-59) / 59 mL in 1 BOTTLE, DROPPER * 1 TUBE in 1 CARTON (42346-550-86) / 85 g in 1 TUBE",
"NDC11Code": "42346-0378-65",
"ProductNDC": "42346-378",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Frankincense And Myrrh Nerve Combo Pack",
"NonProprietaryName": "Menthol",
"DosageFormName": "KIT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251229",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Wise Consumer Products",
"Status": "Active",
"LastUpdate": "2025-12-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251229",
"SamplePackage": "N"
},
{
"NDCCode": "68703-378-02",
"PackageDescription": "59 mL in 1 BOTTLE, GLASS (68703-378-02) ",
"NDC11Code": "68703-0378-02",
"ProductNDC": "68703-378",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nativeremedies Acid Free-flux",
"NonProprietaryName": "Calc Phos 9x, Carbo Veg 6c, Mag Carb 6c, Nat Phos 9x, Silicea 9x",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20211215",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Silver Star Brands",
"SubstanceName": "SODIUM PHOSPHATE, DIBASIC; ACTIVATED CHARCOAL; SILICON DIOXIDE; MAGNESIUM CARBONATE HYDROXIDE; CALCIUM PHOSPHATE",
"StrengthNumber": "9; 6; 9; 6; 9",
"StrengthUnit": "[hp_X]/59mL; [hp_C]/59mL; [hp_X]/59mL; [hp_C]/59mL; [hp_X]/59mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2025-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211215",
"SamplePackage": "N",
"IndicationAndUsage": "Uses*: Homeopathic remedy for the relief of acid, indigestion, and heartburn. *Claims baed on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "22840-5630-2",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (22840-5630-2) ",
"NDC11Code": "22840-5630-02",
"ProductNDC": "22840-5630",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Penicillium Digitatum",
"NonProprietaryName": "Penicillium Digitatum",
"DosageFormName": "SOLUTION",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19810915",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101833",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "PENICILLIUM DIGITATUM",
"StrengthNumber": ".0125",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Fungal Proteins [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19810915",
"SamplePackage": "N",
"IndicationAndUsage": "Allergenic Extracts are indicated for the diagnosis and treatment of patients with immediate hypersensitivity allergy to the respective allergens, inhaled, ingested or otherwise introduced into contact with sensitive tissues. The diagnosis of IgE‑mediated allergy may be established by the allergy history, clinical evaluation, and skin test reactivity. (4,7,11) Immunotherapy with Allergenic Extracts is indicated when testing and patient history have identified the offending allergens and when it is not possible or practical to avoid these allergens. (12‑14) Food extracts have not been proven effective in immunotherapy. The use of Allergenic Extracts for the above purposes should be made only by physicians with special familiarity and knowledge of allergy. (See DOSAGE AND ADMINISTRATION).",
"Description": "Allergenic Extracts are supplied as a sterile solution for intracutaneous or subcutaneous administration. Concentrates contain the soluble extractants of the source material with 0.5% sodium chloride and 0.54% sodium bicarbonate at a pH of 6.8 to 8.4 as aqueous extracts in water for injection or in 50% glycerin. Aqueous extracts contain 0.4% phenol as a preservative and 50% glycerinated extracts contain 0.2% phenol. Diluted aqueous extracts contain Buffered Saline with 0.5% sodium chloride, 0.04% potassium phosphate, 0.11% sodium phosphate heptahydrate, and 0.4% phenol in water for injection. Source materials for these extracts are as follows: Pollens are collected from the respective grasses, weeds, trees, shrubs, cultured plants and flowers. Mold extracts are produced from pure culture mycelial mats. Rusts and smuts are obtained from natural growths. Epidermal extracts are produced from the hide, hair, or feathers containing the natural dander, or from separated dander. Insects are the whole body insects. House dust is made from various dusts ordinarily found in the home with the extract dialyzed to remove low‑molecular weight irritants and concentrated to an extraction ratio of 1:1. Food extracts are prepared from the edible portions of the respective foods, obtained fresh if possible. Certain diagnostic food extracts contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Other miscellaneous inhalants involved in respiratory allergy are obtained in the naturally occurring form to which a patient may be exposed. Extracts are labeled either by weight‑to‑volume (w/v) based on the weight of the source material to the volume of the extracting fluid, or in protein nitrogen units (PNU) based on assay with one PNU representing 0.00001 mg of protein nitrogen."
},
{
"NDCCode": "22840-5630-5",
"PackageDescription": "5 mL in 1 BOTTLE, DROPPER (22840-5630-5) ",
"NDC11Code": "22840-5630-05",
"ProductNDC": "22840-5630",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Penicillium Digitatum",
"NonProprietaryName": "Penicillium Digitatum",
"DosageFormName": "SOLUTION",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19810915",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101833",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "PENICILLIUM DIGITATUM",
"StrengthNumber": ".0125",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Fungal Proteins [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19810915",
"SamplePackage": "N",
"IndicationAndUsage": "Allergenic Extracts are indicated for the diagnosis and treatment of patients with immediate hypersensitivity allergy to the respective allergens, inhaled, ingested or otherwise introduced into contact with sensitive tissues. The diagnosis of IgE‑mediated allergy may be established by the allergy history, clinical evaluation, and skin test reactivity. (4,7,11) Immunotherapy with Allergenic Extracts is indicated when testing and patient history have identified the offending allergens and when it is not possible or practical to avoid these allergens. (12‑14) Food extracts have not been proven effective in immunotherapy. The use of Allergenic Extracts for the above purposes should be made only by physicians with special familiarity and knowledge of allergy. (See DOSAGE AND ADMINISTRATION).",
"Description": "Allergenic Extracts are supplied as a sterile solution for intracutaneous or subcutaneous administration. Concentrates contain the soluble extractants of the source material with 0.5% sodium chloride and 0.54% sodium bicarbonate at a pH of 6.8 to 8.4 as aqueous extracts in water for injection or in 50% glycerin. Aqueous extracts contain 0.4% phenol as a preservative and 50% glycerinated extracts contain 0.2% phenol. Diluted aqueous extracts contain Buffered Saline with 0.5% sodium chloride, 0.04% potassium phosphate, 0.11% sodium phosphate heptahydrate, and 0.4% phenol in water for injection. Source materials for these extracts are as follows: Pollens are collected from the respective grasses, weeds, trees, shrubs, cultured plants and flowers. Mold extracts are produced from pure culture mycelial mats. Rusts and smuts are obtained from natural growths. Epidermal extracts are produced from the hide, hair, or feathers containing the natural dander, or from separated dander. Insects are the whole body insects. House dust is made from various dusts ordinarily found in the home with the extract dialyzed to remove low‑molecular weight irritants and concentrated to an extraction ratio of 1:1. Food extracts are prepared from the edible portions of the respective foods, obtained fresh if possible. Certain diagnostic food extracts contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Other miscellaneous inhalants involved in respiratory allergy are obtained in the naturally occurring form to which a patient may be exposed. Extracts are labeled either by weight‑to‑volume (w/v) based on the weight of the source material to the volume of the extracting fluid, or in protein nitrogen units (PNU) based on assay with one PNU representing 0.00001 mg of protein nitrogen."
},
{
"NDCCode": "54868-5630-0",
"PackageDescription": "30 TABLET in 1 BOTTLE (54868-5630-0)",
"NDC11Code": "54868-5630-00",
"ProductNDC": "54868-5630",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070523",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076685",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"Description": "Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets, USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: butylated hydroxyanisole, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, talc, ascorbic acid, citric acid, hypromellose, polydextrose FCC, polyethylene glycol, triacetin, iron oxide yellow (5 and 10 mg only), iron oxide red (10, 20, and 40 mg only), titanium dioxide (40 and 80 mg only), and FD&C Red # 40/Allura Red Lake (80 mg only)."
},
{
"NDCCode": "54868-5630-1",
"PackageDescription": "90 TABLET in 1 BOTTLE (54868-5630-1)",
"NDC11Code": "54868-5630-01",
"ProductNDC": "54868-5630",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070523",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076685",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"Description": "Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets, USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: butylated hydroxyanisole, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, talc, ascorbic acid, citric acid, hypromellose, polydextrose FCC, polyethylene glycol, triacetin, iron oxide yellow (5 and 10 mg only), iron oxide red (10, 20, and 40 mg only), titanium dioxide (40 and 80 mg only), and FD&C Red # 40/Allura Red Lake (80 mg only)."
},
{
"NDCCode": "55154-5630-9",
"PackageDescription": "30 TABLET, SUGAR COATED in 1 BLISTER PACK (55154-5630-9)",
"NDC11Code": "55154-5630-09",
"ProductNDC": "55154-5630",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlorpromazine Hydrochloride",
"NonProprietaryName": "Chlorpromazine Hydrochloride",
"DosageFormName": "TABLET, SUGAR COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110803",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA084112",
"LabelerName": "Cardinal Health",
"SubstanceName": "CHLORPROMAZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-04-13"
},
{
"NDCCode": "62670-5630-0",
"PackageDescription": "29 mL in 1 BOTTLE (62670-5630-0) ",
"NDC11Code": "62670-5630-00",
"ProductNDC": "62670-5630",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti-bacterial Hand",
"ProprietaryNameSuffix": "Raspberry Lemon Sorbet",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190620",
"EndMarketingDate": "20191220",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Bath & Body Works, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "68",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-12-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190620",
"EndMarketingDatePackage": "20191220",
"SamplePackage": "N"
},
{
"NDCCode": "62670-5630-1",
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20121231</StartMarketingDatePackage>
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<SamplePackage>N</SamplePackage>
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<NDCCode>0378-3702-59</NDCCode>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
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<EndMarketingDate>20170731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
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<Description>Sumatriptan tablets, USP contain sumatriptan succinate, a selective 5-HT1B/1D receptor agonist. Sumatriptan succinate is chemically designated as 3-[2-(Dimethylamino)ethyl]-N-methylindole-5-methanesulfonamide succinate (1:1), and it has the following structure. The empirical formula is C14H21N3O2SC4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate, USP is a white to off-white powder that is readily soluble in water and in saline. Each sumatriptan tablet for oral administration contains 35, 70, or 140 mg of sumatriptan succinate, USP equivalent to 25, 50, or 100 mg of sumatriptan, respectively. Each tablet also contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium lauryl sulfate, titanium dioxide and triacetin. Meets USP Dissolution Test 2.</Description>
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<StartMarketingDatePackage>20220727</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets are indicated for the prevention of pregnancy in women who elect to use combined oral contraceptives as a method of contraception. Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets are indicated for the treatment of moderate acne vulgaris in females, ≥ 15 years of age, who have no known contraindications to combined oral contraceptive therapy, desire oral contraception, have achieved menarche, and are unresponsive to topical anti-acne medications. Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets should be used for the treatment of acne only if the patient desires a combined oral contraceptive for birth control and plans to stay on it for at least 6 months. Combined oral contraceptives are highly effective for pregnancy prevention. Table 2 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. ¶ Foams, creams, gels, vaginal suppositories, and vaginal film. : 1 #Þ Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.</IndicationAndUsage>
<Description>Norethindrone acetate and ethinyl estradiol tablets are graduated estrophasic combined oral contraceptive providing estrogen in a graduated sequence over a 21-day period with a constant dose of progestogen. Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets provide for a continuous dosage regimen consisting of 21 oral contraceptive tablets and seven ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose. Each white to off white tablet contains 1 mg norethindrone acetate [(17 alpha)- 17-(acetyloxy)-19-norpregna-4-en-20-yn-3-one] and 20 mcg ethinyl estradiol [(17 alpha)- 19-norpregna-1,3,5(10)-trien-20-yne-3,17-diol]; each light purple tablet contains 1 mg norethindrone acetate and 30 mcg ethinyl estradiol; and each purple tablet contains 1 mg norethindrone acetate, 35 mcg ethinyl estradiol. Norethindrone acetate and ethinyl estradiol tablets (1 mg and 20 mcg) also contain. Lactose anhydrous, lactose monohydrate, povidone K-25, dl-α-tocopherol, magnesium stearate, microcrystalline cellulose, croscarmellose sodium. Norethindrone acetate and ethinyl estradiol tablets (1 mg and 30 mcg) also contain. Lactose anhydrous, lactose monohydrate, povidone K-25, dl-α-tocopherol, magnesium stearate, microcrystalline cellulose, croscarmellose sodium, aluminium lake of FD and C Blue No. 1, aluminium lake of FD and C Blue No. 2, caramine. Norethindrone acetate and ethinyl estradiol tablets (1 mg and 35 mcg) also contain. Lactose anhydrous, lactose monohydrate, povidone K-25, dl-α-tocopherol, magnesium stearate, microcrystalline cellulose, croscarmellose sodium, aluminium lake of FD and C Blue No. 1, aluminium lake of FD and C Blue No. 2, caramine. The structural formulas are as follows. Each brown tablet contains ferrous fumarate, microcrystalline cellulose, lactose monohydrate, polyvinyl pyrrolidone K-90, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate. Each norethindrone acetate and ethinyl estradiol tablet and ferrous fumarate tablet blister contains five white to off white tablets, seven light purple tablets, nine purple tablets, and seven brown tablets. These tablets are to be taken in the following order: one white to off white each day for five days, then light purple tablet each day for seven days, followed by one purple tablet each day for nine days, and then one brown tablet each day for seven days.</Description>
</NDC>
<NDC>
<NDCCode>0378-8755-59</NDCCode>
<PackageDescription>9 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-8755-59) </PackageDescription>
<NDC11Code>00378-8755-59</NDC11Code>
<ProductNDC>0378-8755</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sumatriptan And Naproxen Sodium</ProprietaryName>
<NonProprietaryName>Sumatriptan And Naproxen Sodium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180904</StartMarketingDate>
<EndMarketingDate>20211231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090872</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>SUMATRIPTAN SUCCINATE; NAPROXEN SODIUM</SubstanceName>
<StrengthNumber>85; 500</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC],Serotonin 1b Receptor Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180904</StartMarketingDatePackage>
<EndMarketingDatePackage>20211231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>58264-0378-2</NDCCode>
<PackageDescription>59.14 mL in 1 BOTTLE, GLASS (58264-0378-2) </PackageDescription>
<NDC11Code>58264-0378-02</NDC11Code>
<ProductNDC>58264-0378</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>G-15</ProprietaryName>
<NonProprietaryName>Hawthorn Leaf With Flower</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>19900101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>DNA Labs, Inc.</LabelerName>
<SubstanceName>HAWTHORN LEAF WITH FLOWER</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_X]/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-01-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19900101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Supports the heart; excessive weight.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0378-3813-01</NDCCode>
<PackageDescription>100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0378-3813-01) </PackageDescription>
<NDC11Code>00378-3813-01</NDC11Code>
<ProductNDC>0378-3813</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clozapine</ProprietaryName>
<NonProprietaryName>Clozapine</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151102</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201824</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CLOZAPINE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clozapine orally disintegrating tablets (Clozapine ODT) is an atypical antipsychotic indicated for: 1 Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, Clozapine ODT should be used only in patients who have failed to respond adequately to standard antipsychotic treatment (1.1), 2 Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior (1.2).</IndicationAndUsage>
<Description>Clozapine, an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine. The structural formula is:. Clozapine Orally Disintegrating Tablets (referred to as Clozapine ODT) are available as peach, orally disintegrating tablets of 25 mg, 100 mg, 150 mg or 200 mg for oral administration without water. Clozapine orally disintegrating tablets may be chewed. Each orally disintegrating tablet contains clozapine, USP equivalent to 25 mg, 100 mg, 150 mg or 200 mg. The active component of clozapine orally disintegrating tablets is clozapine. The remaining components are aspartame, crospovidone, FD&C Yellow No. 6 Aluminum Lake, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, silicon dioxide and sodium stearyl fumarate. Clozapine ODT contains aspartame [see Warnings and Precautions (5.18)]. Phenylalanine is a component of aspartame. Each 25 mg, orally disintegrating tablet contains 3.38 mg aspartame, thus, 1.90 mg phenylalanine. Each 100 mg, orally disintegrating tablet contains 13.52 mg aspartame, thus, 7.59 mg phenylalanine. Each 150 mg, orally disintegrating tablet contains 20.28 mg aspartame, thus, 11.38 mg phenylalanine. Each 200 mg, orally disintegrating tablet contains 27.04 mg aspartame, thus, 15.18 mg phenylalanine.</Description>
</NDC>
<NDC>
<NDCCode>0378-3815-01</NDCCode>
<PackageDescription>100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0378-3815-01) </PackageDescription>
<NDC11Code>00378-3815-01</NDC11Code>
<ProductNDC>0378-3815</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clozapine</ProprietaryName>
<NonProprietaryName>Clozapine</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151102</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201824</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CLOZAPINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clozapine orally disintegrating tablets (Clozapine ODT) is an atypical antipsychotic indicated for: 1 Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, Clozapine ODT should be used only in patients who have failed to respond adequately to standard antipsychotic treatment (1.1), 2 Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior (1.2).</IndicationAndUsage>
<Description>Clozapine, an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine. The structural formula is:. Clozapine Orally Disintegrating Tablets (referred to as Clozapine ODT) are available as peach, orally disintegrating tablets of 25 mg, 100 mg, 150 mg or 200 mg for oral administration without water. Clozapine orally disintegrating tablets may be chewed. Each orally disintegrating tablet contains clozapine, USP equivalent to 25 mg, 100 mg, 150 mg or 200 mg. The active component of clozapine orally disintegrating tablets is clozapine. The remaining components are aspartame, crospovidone, FD&C Yellow No. 6 Aluminum Lake, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, silicon dioxide and sodium stearyl fumarate. Clozapine ODT contains aspartame [see Warnings and Precautions (5.18)]. Phenylalanine is a component of aspartame. Each 25 mg, orally disintegrating tablet contains 3.38 mg aspartame, thus, 1.90 mg phenylalanine. Each 100 mg, orally disintegrating tablet contains 13.52 mg aspartame, thus, 7.59 mg phenylalanine. Each 150 mg, orally disintegrating tablet contains 20.28 mg aspartame, thus, 11.38 mg phenylalanine. Each 200 mg, orally disintegrating tablet contains 27.04 mg aspartame, thus, 15.18 mg phenylalanine.</Description>
</NDC>
<NDC>
<NDCCode>0378-3816-01</NDCCode>
<PackageDescription>100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0378-3816-01) </PackageDescription>
<NDC11Code>00378-3816-01</NDC11Code>
<ProductNDC>0378-3816</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clozapine</ProprietaryName>
<NonProprietaryName>Clozapine</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230816</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201824</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CLOZAPINE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230816</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clozapine orally disintegrating tablets (Clozapine ODT) is an atypical antipsychotic indicated for: 1 Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, Clozapine ODT should be used only in patients who have failed to respond adequately to standard antipsychotic treatment (1.1), 2 Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior (1.2).</IndicationAndUsage>
<Description>Clozapine, an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine. The structural formula is:. Clozapine Orally Disintegrating Tablets (referred to as Clozapine ODT) are available as peach, orally disintegrating tablets of 25 mg, 100 mg, 150 mg or 200 mg for oral administration without water. Clozapine orally disintegrating tablets may be chewed. Each orally disintegrating tablet contains clozapine, USP equivalent to 25 mg, 100 mg, 150 mg or 200 mg. The active component of clozapine orally disintegrating tablets is clozapine. The remaining components are aspartame, crospovidone, FD&C Yellow No. 6 Aluminum Lake, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, silicon dioxide and sodium stearyl fumarate. Clozapine ODT contains aspartame [see Warnings and Precautions (5.18)]. Phenylalanine is a component of aspartame. Each 25 mg, orally disintegrating tablet contains 3.38 mg aspartame, thus, 1.90 mg phenylalanine. Each 100 mg, orally disintegrating tablet contains 13.52 mg aspartame, thus, 7.59 mg phenylalanine. Each 150 mg, orally disintegrating tablet contains 20.28 mg aspartame, thus, 11.38 mg phenylalanine. Each 200 mg, orally disintegrating tablet contains 27.04 mg aspartame, thus, 15.18 mg phenylalanine.</Description>
</NDC>
<NDC>
<NDCCode>0378-3817-01</NDCCode>
<PackageDescription>100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0378-3817-01) </PackageDescription>
<NDC11Code>00378-3817-01</NDC11Code>
<ProductNDC>0378-3817</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clozapine</ProprietaryName>
<NonProprietaryName>Clozapine</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230816</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201824</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CLOZAPINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230816</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clozapine orally disintegrating tablets (Clozapine ODT) is an atypical antipsychotic indicated for: 1 Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, Clozapine ODT should be used only in patients who have failed to respond adequately to standard antipsychotic treatment (1.1), 2 Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior (1.2).</IndicationAndUsage>
<Description>Clozapine, an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo [b,e] [1,4] diazepine. The structural formula is:. Clozapine Orally Disintegrating Tablets (referred to as Clozapine ODT) are available as peach, orally disintegrating tablets of 25 mg, 100 mg, 150 mg or 200 mg for oral administration without water. Clozapine orally disintegrating tablets may be chewed. Each orally disintegrating tablet contains clozapine, USP equivalent to 25 mg, 100 mg, 150 mg or 200 mg. The active component of clozapine orally disintegrating tablets is clozapine. The remaining components are aspartame, crospovidone, FD&C Yellow No. 6 Aluminum Lake, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, silicon dioxide and sodium stearyl fumarate. Clozapine ODT contains aspartame [see Warnings and Precautions (5.18)]. Phenylalanine is a component of aspartame. Each 25 mg, orally disintegrating tablet contains 3.38 mg aspartame, thus, 1.90 mg phenylalanine. Each 100 mg, orally disintegrating tablet contains 13.52 mg aspartame, thus, 7.59 mg phenylalanine. Each 150 mg, orally disintegrating tablet contains 20.28 mg aspartame, thus, 11.38 mg phenylalanine. Each 200 mg, orally disintegrating tablet contains 27.04 mg aspartame, thus, 15.18 mg phenylalanine.</Description>
</NDC>
<NDC>
<NDCCode>42346-378-65</NDCCode>
<PackageDescription>1 KIT in 1 KIT (42346-378-65) * 1 BOTTLE, DROPPER in 1 CARTON (42346-360-59) / 59 mL in 1 BOTTLE, DROPPER * 1 TUBE in 1 CARTON (42346-550-86) / 85 g in 1 TUBE</PackageDescription>
<NDC11Code>42346-0378-65</NDC11Code>
<ProductNDC>42346-378</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Frankincense And Myrrh Nerve Combo Pack</ProprietaryName>
<NonProprietaryName>Menthol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20251229</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Wise Consumer Products</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251229</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68703-378-02</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, GLASS (68703-378-02) </PackageDescription>
<NDC11Code>68703-0378-02</NDC11Code>
<ProductNDC>68703-378</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nativeremedies Acid Free-flux</ProprietaryName>
<NonProprietaryName>Calc Phos 9x, Carbo Veg 6c, Mag Carb 6c, Nat Phos 9x, Silicea 9x</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211215</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Silver Star Brands</LabelerName>
<SubstanceName>SODIUM PHOSPHATE, DIBASIC; ACTIVATED CHARCOAL; SILICON DIOXIDE; MAGNESIUM CARBONATE HYDROXIDE; CALCIUM PHOSPHATE</SubstanceName>
<StrengthNumber>9; 6; 9; 6; 9</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_C]/59mL; [hp_X]/59mL; [hp_C]/59mL; [hp_X]/59mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses*: Homeopathic remedy for the relief of acid, indigestion, and heartburn. *Claims baed on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>22840-5630-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (22840-5630-2) </PackageDescription>
<NDC11Code>22840-5630-02</NDC11Code>
<ProductNDC>22840-5630</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Penicillium Digitatum</ProprietaryName>
<NonProprietaryName>Penicillium Digitatum</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19810915</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101833</ApplicationNumber>
<LabelerName>Greer Laboratories, Inc.</LabelerName>
<SubstanceName>PENICILLIUM DIGITATUM</SubstanceName>
<StrengthNumber>.0125</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Fungal Proteins [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19810915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Allergenic Extracts are indicated for the diagnosis and treatment of patients with immediate hypersensitivity allergy to the respective allergens, inhaled, ingested or otherwise introduced into contact with sensitive tissues. The diagnosis of IgE‑mediated allergy may be established by the allergy history, clinical evaluation, and skin test reactivity. (4,7,11) Immunotherapy with Allergenic Extracts is indicated when testing and patient history have identified the offending allergens and when it is not possible or practical to avoid these allergens. (12‑14) Food extracts have not been proven effective in immunotherapy. The use of Allergenic Extracts for the above purposes should be made only by physicians with special familiarity and knowledge of allergy. (See DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Allergenic Extracts are supplied as a sterile solution for intracutaneous or subcutaneous administration. Concentrates contain the soluble extractants of the source material with 0.5% sodium chloride and 0.54% sodium bicarbonate at a pH of 6.8 to 8.4 as aqueous extracts in water for injection or in 50% glycerin. Aqueous extracts contain 0.4% phenol as a preservative and 50% glycerinated extracts contain 0.2% phenol. Diluted aqueous extracts contain Buffered Saline with 0.5% sodium chloride, 0.04% potassium phosphate, 0.11% sodium phosphate heptahydrate, and 0.4% phenol in water for injection. Source materials for these extracts are as follows: Pollens are collected from the respective grasses, weeds, trees, shrubs, cultured plants and flowers. Mold extracts are produced from pure culture mycelial mats. Rusts and smuts are obtained from natural growths. Epidermal extracts are produced from the hide, hair, or feathers containing the natural dander, or from separated dander. Insects are the whole body insects. House dust is made from various dusts ordinarily found in the home with the extract dialyzed to remove low‑molecular weight irritants and concentrated to an extraction ratio of 1:1. Food extracts are prepared from the edible portions of the respective foods, obtained fresh if possible. Certain diagnostic food extracts contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Other miscellaneous inhalants involved in respiratory allergy are obtained in the naturally occurring form to which a patient may be exposed. Extracts are labeled either by weight‑to‑volume (w/v) based on the weight of the source material to the volume of the extracting fluid, or in protein nitrogen units (PNU) based on assay with one PNU representing 0.00001 mg of protein nitrogen.</Description>
</NDC>
<NDC>
<NDCCode>22840-5630-5</NDCCode>
<PackageDescription>5 mL in 1 BOTTLE, DROPPER (22840-5630-5) </PackageDescription>
<NDC11Code>22840-5630-05</NDC11Code>
<ProductNDC>22840-5630</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Penicillium Digitatum</ProprietaryName>
<NonProprietaryName>Penicillium Digitatum</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19810915</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101833</ApplicationNumber>
<LabelerName>Greer Laboratories, Inc.</LabelerName>
<SubstanceName>PENICILLIUM DIGITATUM</SubstanceName>
<StrengthNumber>.0125</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Fungal Proteins [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19810915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Allergenic Extracts are indicated for the diagnosis and treatment of patients with immediate hypersensitivity allergy to the respective allergens, inhaled, ingested or otherwise introduced into contact with sensitive tissues. The diagnosis of IgE‑mediated allergy may be established by the allergy history, clinical evaluation, and skin test reactivity. (4,7,11) Immunotherapy with Allergenic Extracts is indicated when testing and patient history have identified the offending allergens and when it is not possible or practical to avoid these allergens. (12‑14) Food extracts have not been proven effective in immunotherapy. The use of Allergenic Extracts for the above purposes should be made only by physicians with special familiarity and knowledge of allergy. (See DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Allergenic Extracts are supplied as a sterile solution for intracutaneous or subcutaneous administration. Concentrates contain the soluble extractants of the source material with 0.5% sodium chloride and 0.54% sodium bicarbonate at a pH of 6.8 to 8.4 as aqueous extracts in water for injection or in 50% glycerin. Aqueous extracts contain 0.4% phenol as a preservative and 50% glycerinated extracts contain 0.2% phenol. Diluted aqueous extracts contain Buffered Saline with 0.5% sodium chloride, 0.04% potassium phosphate, 0.11% sodium phosphate heptahydrate, and 0.4% phenol in water for injection. Source materials for these extracts are as follows: Pollens are collected from the respective grasses, weeds, trees, shrubs, cultured plants and flowers. Mold extracts are produced from pure culture mycelial mats. Rusts and smuts are obtained from natural growths. Epidermal extracts are produced from the hide, hair, or feathers containing the natural dander, or from separated dander. Insects are the whole body insects. House dust is made from various dusts ordinarily found in the home with the extract dialyzed to remove low‑molecular weight irritants and concentrated to an extraction ratio of 1:1. Food extracts are prepared from the edible portions of the respective foods, obtained fresh if possible. Certain diagnostic food extracts contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Other miscellaneous inhalants involved in respiratory allergy are obtained in the naturally occurring form to which a patient may be exposed. Extracts are labeled either by weight‑to‑volume (w/v) based on the weight of the source material to the volume of the extracting fluid, or in protein nitrogen units (PNU) based on assay with one PNU representing 0.00001 mg of protein nitrogen.</Description>
</NDC>
<NDC>
<NDCCode>54868-5630-0</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (54868-5630-0)</PackageDescription>
<NDC11Code>54868-5630-00</NDC11Code>
<ProductNDC>54868-5630</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Simvastatin</ProprietaryName>
<NonProprietaryName>Simvastatin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070523</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076685</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>SIMVASTATIN</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<Description>Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets, USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: butylated hydroxyanisole, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, talc, ascorbic acid, citric acid, hypromellose, polydextrose FCC, polyethylene glycol, triacetin, iron oxide yellow (5 and 10 mg only), iron oxide red (10, 20, and 40 mg only), titanium dioxide (40 and 80 mg only), and FD&C Red # 40/Allura Red Lake (80 mg only).</Description>
</NDC>
<NDC>
<NDCCode>54868-5630-1</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (54868-5630-1)</PackageDescription>
<NDC11Code>54868-5630-01</NDC11Code>
<ProductNDC>54868-5630</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Simvastatin</ProprietaryName>
<NonProprietaryName>Simvastatin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070523</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076685</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>SIMVASTATIN</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<Description>Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets, USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: butylated hydroxyanisole, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, talc, ascorbic acid, citric acid, hypromellose, polydextrose FCC, polyethylene glycol, triacetin, iron oxide yellow (5 and 10 mg only), iron oxide red (10, 20, and 40 mg only), titanium dioxide (40 and 80 mg only), and FD&C Red # 40/Allura Red Lake (80 mg only).</Description>
</NDC>
<NDC>
<NDCCode>55154-5630-9</NDCCode>
<PackageDescription>30 TABLET, SUGAR COATED in 1 BLISTER PACK (55154-5630-9)</PackageDescription>
<NDC11Code>55154-5630-09</NDC11Code>
<ProductNDC>55154-5630</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chlorpromazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Chlorpromazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, SUGAR COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110803</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA084112</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>CHLORPROMAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-04-13</LastUpdate>
</NDC>
<NDC>
<NDCCode>62670-5630-0</NDCCode>
<PackageDescription>29 mL in 1 BOTTLE (62670-5630-0) </PackageDescription>
<NDC11Code>62670-5630-00</NDC11Code>
<ProductNDC>62670-5630</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti-bacterial Hand</ProprietaryName>
<ProprietaryNameSuffix>Raspberry Lemon Sorbet</ProprietaryNameSuffix>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190620</StartMarketingDate>
<EndMarketingDate>20191220</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Bath & Body Works, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>68</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-12-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190620</StartMarketingDatePackage>
<EndMarketingDatePackage>20191220</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62670-5630-1</NDCCode>
<PackageDescription>73 mL in 1 BOTTLE (62670-5630-1) </PackageDescription>
<NDC11Code>62670-5630-01</NDC11Code>
<ProductNDC>62670-5630</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti-bacterial Hand</ProprietaryName>
<ProprietaryNameSuffix>Raspberry Lemon Sorbet</ProprietaryNameSuffix>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190620</StartMarketingDate>
<EndMarketingDate>20191220</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Bath & Body Works, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>68</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-12-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190620</StartMarketingDatePackage>
<EndMarketingDatePackage>20191220</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62670-5630-3</NDCCode>
<PackageDescription>236 mL in 1 BOTTLE, PUMP (62670-5630-3) </PackageDescription>
<NDC11Code>62670-5630-03</NDC11Code>
<ProductNDC>62670-5630</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti-bacterial Hand</ProprietaryName>
<ProprietaryNameSuffix>Raspberry Lemon Sorbet</ProprietaryNameSuffix>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190620</StartMarketingDate>
<EndMarketingDate>20191220</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Bath & Body Works, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>68</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-12-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190620</StartMarketingDatePackage>
<EndMarketingDatePackage>20191220</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0078-0378-42</NDCCode>
<PackageDescription>8 PATCH in 1 CARTON (0078-0378-42) > 3.5 d in 1 PATCH</PackageDescription>
<NDC11Code>00078-0378-42</NDC11Code>
<ProductNDC>0078-0378</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Combipatch</ProprietaryName>
<NonProprietaryName>Estradiol And Norethindrone Acetate</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20000101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020870</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>ESTRADIOL; NORETHINDRONE ACETATE</SubstanceName>
<StrengthNumber>.05; .25</StrengthNumber>
<StrengthUnit>mg/d; mg/d</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-09-19</LastUpdate>
</NDC>
<NDC>
<NDCCode>0078-0378-45</NDCCode>
<PackageDescription>24 POUCH in 1 CARTON (0078-0378-45) > 3.5 d in 1 POUCH</PackageDescription>
<NDC11Code>00078-0378-45</NDC11Code>
<ProductNDC>0078-0378</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Combipatch</ProprietaryName>
<NonProprietaryName>Estradiol And Norethindrone Acetate</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20000101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020870</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>ESTRADIOL; NORETHINDRONE ACETATE</SubstanceName>
<StrengthNumber>.05; .25</StrengthNumber>
<StrengthUnit>mg/d; mg/d</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-09-19</LastUpdate>
</NDC>
</NDCList>