{
"NDC": [
{
"NDCCode": "63044-631-19",
"PackageDescription": "100 BLISTER PACK in 1 BOX (63044-631-19) / 1 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "63044-0631-19",
"ProductNDC": "63044-631",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hematogen",
"NonProprietaryName": "Ferrous Fumarate, Ascorbic Acid, Intrinsic Factor , Cyanocobalamin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20070510",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Nnodum Pharmaceuticals",
"SubstanceName": "ASCORBIC ACID; CYANOCOBALAMIN; FERROUS FUMARATE; INTRINSIC FACTOR",
"StrengthNumber": "250; 10; 66; 100",
"StrengthUnit": "mg/1; ug/1; mg/1; mg/1",
"Pharm_Classes": "Ascorbic Acid [CS], Vitamin B 12 [CS], Vitamin B12 [EPC], Vitamin C [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20070510",
"SamplePackage": "N",
"IndicationAndUsage": "For the treatment of all anemias responsive to oral iron therapy, such as hypochromic anemia associated with pregnancy, chronic or acute blood loss, dietary restriction, metabolic disease and post-surgical convalescence."
},
{
"NDCCode": "61786-631-19",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61786-631-19)",
"NDC11Code": "61786-0631-19",
"ProductNDC": "61786-631",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate",
"NonProprietaryName": "Metoprolol Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160322",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200981",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-10-12",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "69842-631-19",
"PackageDescription": "1 TUBE in 1 CARTON (69842-631-19) / 9.4 g in 1 TUBE",
"NDC11Code": "69842-0631-19",
"ProductNDC": "69842-631",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "4x Medicated Toothache And Gum Cream",
"NonProprietaryName": "Benzocaine",
"DosageFormName": "CREAM",
"RouteName": "ORAL",
"StartMarketingDate": "20200605",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M022",
"LabelerName": "CVS",
"SubstanceName": "BENZALKONIUM CHLORIDE; ZINC CHLORIDE; BENZOCAINE; MENTHOL, UNSPECIFIED FORM",
"StrengthNumber": ".13; .15; 20; .26",
"StrengthUnit": "g/100g; g/100g; g/100g; g/100g",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200605",
"SamplePackage": "N",
"IndicationAndUsage": "for the temporary relief of pain due to toothaches * to help protect against infection or minor oral irritation."
},
{
"NDCCode": "0074-1017-14",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (0074-1017-14) / 1 KIT in 1 BLISTER PACK * 7 CAPSULE in 1 BLISTER PACK * 7 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "00074-1017-14",
"ProductNDC": "0074-1017",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oriahnn",
"NonProprietaryName": "Elagolix And Estradiol And Norethisterone",
"DosageFormName": "KIT",
"StartMarketingDate": "20200529",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213388",
"LabelerName": "AbbVie Inc.",
"Status": "Active",
"LastUpdate": "2025-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200924",
"SamplePackage": "Y",
"IndicationAndUsage": "ORIAHNN is indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. Limitation of Use. Use of ORIAHNN should be limited to 24 months due to the risk of continued bone loss, which may not be reversible [see Dosage and Administration (2.1) and Warnings and Precautions (5.2)].",
"Description": "ORIAHNN consists of two capsules: one to be taken orally in the morning (AM) and one to be taken orally in the evening (PM). The AM capsule is white and yellow and contains 300 mg elagolix (equivalent to 310.4 mg of elagolix sodium), 1 mg estradiol, and 0.5 mg norethindrone acetate. The PM capsule is white and light blue and contains 300 mg of elagolix (equivalent to 310 mg of elagolix sodium). Elagolix. Elagolix sodium is the sodium salt of the active moiety elagolix, a nonpeptide small molecule, GnRH receptor antagonist. Elagolix sodium is chemically described as sodium 4-({(1R)-2-[5-(2-fluoro-3-methoxyphenyl)-3-{[2-fluoro-6-(trifluoromethyl)phenyl]methyl}-4-methyl-2,6-dioxo-3,6-dihydropyrimidin-1(2H)-yl]-1-phenylethyl}amino)butanoate. Elagolix sodium has a molecular formula of C32H29F5N3O5Na and a molecular weight of 653.58. Elagolix free acid has a molecular formula of C32H30F5N3O5 and a molecular weight of 631.60. Elagolix sodium has the following structural formula:. Elagolix sodium is a white to off-white to light yellow powder and is freely soluble in water. Estradiol. Estradiol (E2), an estrogen, is a white or almost white crystalline powder. Its chemical name is estra-1,3,5(10)-triene-3,17β-diol with the molecular formula of C18H24O2, and molecular weight of 272.38. The structural formula of E2 is as follows:. Norethindrone acetate. Norethindrone acetate (NETA), a progestin, is a white or yellowish white crystalline powder. Its chemical name is 17β-acetoxy-19-nor-17α-pregn-4-en-20-yn-3-one with the molecular formula of C22H28O3 and molecular weight of 340.46. ORIAHNN morning (AM) capsules contain the following inactive ingredients: anhydrous sodium carbonate, polyethylene glycol 3350, crospovidone, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, purified water, lactose monohydrate, starch (corn), copovidone, talc, hypromellose, triacetin, and gelatin capsule shell. The capsule shell contains the following ingredients: FD&C Red #40, FD&C Yellow #5 [see Warnings and Precautions (5.12)], FD&C Yellow #6, titanium dioxide, gelatin, and printing ink (shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water). ORIAHNN evening (PM) capsules contain the following inactive ingredients: anhydrous sodium carbonate, polyethylene glycol 3350, crospovidone, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, purified water, and gelatin capsule shell. The capsule shell contains the following ingredients: FD&C Blue #2, FDA/E172 yellow iron oxide, titanium dioxide, gelatin, and printing ink (shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water)."
},
{
"NDCCode": "0074-1017-56",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (0074-1017-56) / 1 KIT in 1 BLISTER PACK * 7 CAPSULE in 1 BLISTER PACK * 7 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "00074-1017-56",
"ProductNDC": "0074-1017",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oriahnn",
"NonProprietaryName": "Elagolix And Estradiol And Norethisterone",
"DosageFormName": "KIT",
"StartMarketingDate": "20200529",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213388",
"LabelerName": "AbbVie Inc.",
"Status": "Active",
"LastUpdate": "2025-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200529",
"SamplePackage": "N",
"IndicationAndUsage": "ORIAHNN is indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. Limitation of Use. Use of ORIAHNN should be limited to 24 months due to the risk of continued bone loss, which may not be reversible [see Dosage and Administration (2.1) and Warnings and Precautions (5.2)].",
"Description": "ORIAHNN consists of two capsules: one to be taken orally in the morning (AM) and one to be taken orally in the evening (PM). The AM capsule is white and yellow and contains 300 mg elagolix (equivalent to 310.4 mg of elagolix sodium), 1 mg estradiol, and 0.5 mg norethindrone acetate. The PM capsule is white and light blue and contains 300 mg of elagolix (equivalent to 310 mg of elagolix sodium). Elagolix. Elagolix sodium is the sodium salt of the active moiety elagolix, a nonpeptide small molecule, GnRH receptor antagonist. Elagolix sodium is chemically described as sodium 4-({(1R)-2-[5-(2-fluoro-3-methoxyphenyl)-3-{[2-fluoro-6-(trifluoromethyl)phenyl]methyl}-4-methyl-2,6-dioxo-3,6-dihydropyrimidin-1(2H)-yl]-1-phenylethyl}amino)butanoate. Elagolix sodium has a molecular formula of C32H29F5N3O5Na and a molecular weight of 653.58. Elagolix free acid has a molecular formula of C32H30F5N3O5 and a molecular weight of 631.60. Elagolix sodium has the following structural formula:. Elagolix sodium is a white to off-white to light yellow powder and is freely soluble in water. Estradiol. Estradiol (E2), an estrogen, is a white or almost white crystalline powder. Its chemical name is estra-1,3,5(10)-triene-3,17β-diol with the molecular formula of C18H24O2, and molecular weight of 272.38. The structural formula of E2 is as follows:. Norethindrone acetate. Norethindrone acetate (NETA), a progestin, is a white or yellowish white crystalline powder. Its chemical name is 17β-acetoxy-19-nor-17α-pregn-4-en-20-yn-3-one with the molecular formula of C22H28O3 and molecular weight of 340.46. ORIAHNN morning (AM) capsules contain the following inactive ingredients: anhydrous sodium carbonate, polyethylene glycol 3350, crospovidone, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, purified water, lactose monohydrate, starch (corn), copovidone, talc, hypromellose, triacetin, and gelatin capsule shell. The capsule shell contains the following ingredients: FD&C Red #40, FD&C Yellow #5 [see Warnings and Precautions (5.12)], FD&C Yellow #6, titanium dioxide, gelatin, and printing ink (shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water). ORIAHNN evening (PM) capsules contain the following inactive ingredients: anhydrous sodium carbonate, polyethylene glycol 3350, crospovidone, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, purified water, and gelatin capsule shell. The capsule shell contains the following ingredients: FD&C Blue #2, FDA/E172 yellow iron oxide, titanium dioxide, gelatin, and printing ink (shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water)."
},
{
"NDCCode": "42858-631-01",
"PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42858-631-01) ",
"NDC11Code": "42858-0631-01",
"ProductNDC": "42858-631",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ms Contin",
"NonProprietaryName": "Morphine Sulfate",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170515",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019516",
"LabelerName": "Rhodes Pharmaceuticals LLC",
"SubstanceName": "MORPHINE SULFATE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170515",
"SamplePackage": "N",
"IndicationAndUsage": "MS CONTIN is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.2)], reserve opioid analgesics, including MS CONTIN, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 MS CONTIN is not indicated as an as-needed (prn) analgesic.",
"Description": "MS CONTIN (morphine sulfate extended-release tablets) is for oral use and contains morphine sulfate, an opioid agonist. Each tablet contains the following inactive ingredients common to all strengths: cetostearyl alcohol, hydroxyethyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, talc, and titanium dioxide. The tablet strengths describe the amount of morphine per tablet as the pentahydrated sulfate salt (morphine sulfate). The 15 mg tablets also contain: FD&C Blue No. 2, lactose, polysorbate 80. The 30 mg tablets also contain: D&C Red No. 7, FD&C Blue No. 1, lactose, polysorbate 80. The 60 mg tablets also contain: D&C Red No. 30, D&C Yellow No. 10, hydroxypropyl cellulose, lactose. Morphine sulfate is an odorless, white, crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its molecular weight is 758.83 and its structural formula is."
},
{
"NDCCode": "50268-631-15",
"PackageDescription": "50 BLISTER PACK in 1 BOX (50268-631-15) / 1 TABLET in 1 BLISTER PACK (50268-631-11) ",
"NDC11Code": "50268-0631-15",
"ProductNDC": "50268-631",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine Fumarate",
"NonProprietaryName": "Quetiapine Fumarate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160526",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201504",
"LabelerName": "AvPAK",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160526",
"SamplePackage": "N",
"IndicationAndUsage": "Quetiapine is an atypical antipsychotic indicated for the treatment of. · Schizophrenia (1.1). · Bipolar I disorder manic episodes (1.2). · Bipolar disorder, depressive episodes (1.2).",
"Description": "Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl) ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C 42H 50N 6O 4S 2C 4H 4O 4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is:. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablets, USP is supplied for oral administration as 25 mg (round peach), 50 mg (round, white), 100 mg (round yellow), 150 mg (round, off white to light yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are povidone, dibasic dicalcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, hypromellose, polyethylene glycol and titanium dioxide. The 25 mg tablets contain red iron oxide and yellow iron oxide and the 100 mg, 150 mg and 400 mg tablets contain only yellow iron oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate USP equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate USP equivalent to 100 mg quetiapine.Each 150 mg tablet contains 172.70 mg of quetiapine fumarate USP equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.27 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.40 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.54 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine."
},
{
"NDCCode": "51150-631-01",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (51150-631-01) / 50 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "51150-0631-01",
"ProductNDC": "51150-631",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lancome Paris Uv Expert Supra Screen Mineral Invisible Sunscreen Spf 50 Serum",
"NonProprietaryName": "Titanium Dioxide And Zinc Oxide",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260401",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "SICOS ET CIE",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "26.6; 153.5",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
"Status": "Active",
"LastUpdate": "2026-05-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260401",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging cause by the sun."
},
{
"NDCCode": "51150-631-02",
"PackageDescription": "1 JAR in 1 CARTON (51150-631-02) / 30 mL in 1 JAR",
"NDC11Code": "51150-0631-02",
"ProductNDC": "51150-631",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lancome Paris Uv Expert Supra Screen Mineral Invisible Sunscreen Spf 50 Serum",
"NonProprietaryName": "Titanium Dioxide And Zinc Oxide",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260401",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "SICOS ET CIE",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "26.6; 153.5",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
"Status": "Active",
"LastUpdate": "2026-05-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260515",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging cause by the sun."
},
{
"NDCCode": "55700-631-10",
"PackageDescription": "10 TABLET, FILM COATED in 1 BOTTLE (55700-631-10) ",
"NDC11Code": "55700-0631-10",
"ProductNDC": "55700-631",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron Hydrochloride",
"NonProprietaryName": "Ondansetron Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180525",
"EndMarketingDate": "20280131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078539",
"LabelerName": "Quality Care Products LLC",
"SubstanceName": "ONDANSETRON HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180525",
"EndMarketingDatePackage": "20270531",
"SamplePackage": "N",
"IndicationAndUsage": "Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with. Ondansetron tablets are also indicated for the prevention of postoperative nausea and/or vomiting.",
"Description": "The active ingredient in ondansetron tablets, USP is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula: The molecular formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.9. Ondansetron hydrochloride USP (dihydrate) is a white to off-white powder that is soluble in water and normal saline. Ondansetron tablets, USP for oral administration contain ondansetron hydrochloride USP (dihydrate) equivalent to 4 mg or 8 mg or 24 mg of ondansetron. Each film-coated tablet also contains the inactive ingredients anhydrous lactose, microcrystalline cellulose, pregelatinized starch (maize), magnesium stearate, triacetin, titanium dioxide and hypromellose. In addition 8 mg tablet also contains iron oxide yellow and 24 mg tablet also contains iron oxide red. Meets USP dissolution test 6."
},
{
"NDCCode": "55700-631-20",
"PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE (55700-631-20) ",
"NDC11Code": "55700-0631-20",
"ProductNDC": "55700-631",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron Hydrochloride",
"NonProprietaryName": "Ondansetron Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180525",
"EndMarketingDate": "20280131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078539",
"LabelerName": "Quality Care Products LLC",
"SubstanceName": "ONDANSETRON HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180525",
"EndMarketingDatePackage": "20270531",
"SamplePackage": "N",
"IndicationAndUsage": "Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with. Ondansetron tablets are also indicated for the prevention of postoperative nausea and/or vomiting.",
"Description": "The active ingredient in ondansetron tablets, USP is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula: The molecular formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.9. Ondansetron hydrochloride USP (dihydrate) is a white to off-white powder that is soluble in water and normal saline. Ondansetron tablets, USP for oral administration contain ondansetron hydrochloride USP (dihydrate) equivalent to 4 mg or 8 mg or 24 mg of ondansetron. Each film-coated tablet also contains the inactive ingredients anhydrous lactose, microcrystalline cellulose, pregelatinized starch (maize), magnesium stearate, triacetin, titanium dioxide and hypromellose. In addition 8 mg tablet also contains iron oxide yellow and 24 mg tablet also contains iron oxide red. Meets USP dissolution test 6."
},
{
"NDCCode": "55700-631-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (55700-631-30) ",
"NDC11Code": "55700-0631-30",
"ProductNDC": "55700-631",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron Hydrochloride",
"NonProprietaryName": "Ondansetron Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180525",
"EndMarketingDate": "20280131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078539",
"LabelerName": "Quality Care Products LLC",
"SubstanceName": "ONDANSETRON HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180525",
"EndMarketingDatePackage": "20280131",
"SamplePackage": "N",
"IndicationAndUsage": "Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with. Ondansetron tablets are also indicated for the prevention of postoperative nausea and/or vomiting.",
"Description": "The active ingredient in ondansetron tablets, USP is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula: The molecular formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.9. Ondansetron hydrochloride USP (dihydrate) is a white to off-white powder that is soluble in water and normal saline. Ondansetron tablets, USP for oral administration contain ondansetron hydrochloride USP (dihydrate) equivalent to 4 mg or 8 mg or 24 mg of ondansetron. Each film-coated tablet also contains the inactive ingredients anhydrous lactose, microcrystalline cellulose, pregelatinized starch (maize), magnesium stearate, triacetin, titanium dioxide and hypromellose. In addition 8 mg tablet also contains iron oxide yellow and 24 mg tablet also contains iron oxide red. Meets USP dissolution test 6."
},
{
"NDCCode": "63323-631-50",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (63323-631-50) / 50 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "63323-0631-50",
"ProductNDC": "63323-631",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Leucovorin Calcium",
"NonProprietaryName": "Leucovorin Calcium",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20180727",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207226",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "LEUCOVORIN CALCIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Folate Analog [EPC], Folic Acid [CS]",
"Status": "Active",
"LastUpdate": "2024-10-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180727",
"SamplePackage": "N",
"IndicationAndUsage": "Leucovorin calcium rescue is indicated after high dose methotrexate therapy in osteosarcoma. Leucovorin calcium is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosages of folic acid antagonists. Leucovorin calcium is indicated in the treatment of megaloblastic anemias due to folic acid deficiency when oral therapy is not feasible. Leucovorin is also indicated for use in combination with 5-fluorouracil to prolong survival in the palliative treatment of patients with advanced colorectal cancer. Leucovorin should not be mixed in the same infusion as 5-fluorouracil because a precipitate may form.",
"Description": "Leucovorin is one of several active, chemically reduced derivatives of folic acid. It is useful as an antidote to drugs which act as folic acid antagonists.Also known as folinic acid, Citrovorum factor, or 5-formyl-5,6,7,8-tetrahydrofolic acid, this compound has the chemical designation of Calcium N-[p-[[[(6RS)-2-amino-5-formyl-5,6,7,8-tetrahydro-4-hydroxy-6-pteridinyl]methyl]amino]benzoyl]-L-glutamate (1:1). The structural formula of leucovorin calcium is. C20H21CaN7O7 M.W=511.50 Leucovorin Calcium Injection USP is a sterile, preservative-free solution indicated for intramuscular (IM) or intravenous (IV) administration in a 50 mL single-dose vial. Each mL contains leucovorin calcium equivalent to 10 mg Leucovorin, USP; 8 mg sodium chloride; sodium hydroxide and/or hydrochloric acid for pH adjustment (pH 6.5 to 8.5). There is 0.004 mEq of calcium per mg of leucovorin. Solution contains no bacteriostat or antimicrobial agents. One milligram of leucovorin calcium contains 0.002 mmol of leucovorin and 0.002 mmol of calcium."
},
{
"NDCCode": "69097-579-67",
"PackageDescription": "1 DOSE PACK in 1 CARTON (69097-579-67) / 1 GRANULE, FOR SOLUTION in 1 DOSE PACK",
"NDC11Code": "69097-0579-67",
"ProductNDC": "69097-579",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fosfomycin Tromethamine",
"NonProprietaryName": "Fosfomycin Tromethamine",
"DosageFormName": "GRANULE, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20220126",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211881",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "FOSFOMYCIN TROMETHAMINE",
"StrengthNumber": "3",
"StrengthUnit": "g/1",
"Status": "Active",
"LastUpdate": "2025-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220126",
"SamplePackage": "N",
"IndicationAndUsage": "Fosfomycin tromethamine granules for oral solution is indicated only for the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of Escherichia coli and Enterococcus faecalis. Fosfomycin tromethamine granules for oral solution is not indicated for the treatment of pyelonephritis or perinephric abscess. If persistence or reappearance of bacteriuria occurs after treatment with fosfomycin tromethamine granules for oral solution, other therapeutic agents should be selected. (See PRECAUTIONS and CLINICAL STUDIES sections.).",
"Description": "Fosfomycin tromethamine granules for oral solution contains fosfomycin tromethamine, a synthetic, broad spectrum, bactericidal antibiotic for oral administration. It is available as a single-dose sachet which contains white granules consisting of 5.631 grams of fosfomycin tromethamine (equivalent to 3 grams of fosfomycin), and the following inactive ingredients: mandarin flavor, orange powder flavor, saccharin, and sucrose. The contents of the sachet must be dissolved in water. Fosfomycin tromethamine, a phosphonic acid derivative, is available as (1R,2S)-(1,2-epoxypropyl)phosphonic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1). It is a white or almost white, hygroscopic powder with a molecular weight of 259.19. Its empirical formula is C3H7O4P.C4H11NO3, and its chemical structure is as follows:."
},
{
"NDCCode": "82046-631-01",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (82046-631-01) / 50 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "82046-0631-01",
"ProductNDC": "82046-631",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lancome Paris Uv Expert Supra Screen Mineral Invisible Sunscreen Spf 50 Serum",
"NonProprietaryName": "Titanium Dioxide And Zinc Oxide",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260401",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "L�Oreal USA Products Inc.",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "26.6; 153.5",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
"Status": "Active",
"LastUpdate": "2026-05-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260401",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging cause by the sun."
},
{
"NDCCode": "82046-631-02",
"PackageDescription": "1 JAR in 1 CARTON (82046-631-02) / 30 mL in 1 JAR",
"NDC11Code": "82046-0631-02",
"ProductNDC": "82046-631",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lancome Paris Uv Expert Supra Screen Mineral Invisible Sunscreen Spf 50 Serum",
"NonProprietaryName": "Titanium Dioxide And Zinc Oxide",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260401",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "L�Oreal USA Products Inc.",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "26.6; 153.5",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
"Status": "Active",
"LastUpdate": "2026-05-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260515",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging cause by the sun."
},
{
"NDCCode": "84515-631-01",
"PackageDescription": "15 mL in 1 BOX (84515-631-01) ",
"NDC11Code": "84515-0631-01",
"ProductNDC": "84515-631",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rosemary Oilfor For Hair And Scalp",
"NonProprietaryName": "Rosemary Oilfor For Hair And Scalp",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241022",
"EndMarketingDate": "20311231",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M032",
"LabelerName": "Yiwu Xinqian E Commerce Co Ltd",
"SubstanceName": "MINOXIDIL",
"StrengthNumber": "5",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20241022",
"EndMarketingDatePackage": "20311231",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "63044-030-60",
"PackageDescription": "56.6 g in 1 TUBE (63044-030-60) ",
"NDC11Code": "63044-0030-60",
"ProductNDC": "63044-030",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ziks Arthritis Pain Relief",
"NonProprietaryName": "Ziks Arthritis Pain Relief",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19991110",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Nnodum Pharmaceuticals",
"SubstanceName": "METHYL SALICYLATE; MENTHOL; CAPSAICIN",
"StrengthNumber": "6.79; .566; .014",
"StrengthUnit": "mg/g; mg/g; mg/g",
"Status": "Active",
"LastUpdate": "2025-12-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19991110",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of minor aches and pain of muscles and joints associated with arthritis, simple backache, strains and sprains. *Products containing purified capsaicin are most recommended by doctors and pharmacists.",
"Description": "Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a physician. A passing burning sensation may occur upon application, but generally disappears in several days. Application schedules of less than 3 to 4 times a day may not provide optimum pain relief ant the burning sensation may persist. WASH HANDS WITH SOAP AND WATER AFTER APPLYING UNLESS TREATING HANDS."
},
{
"NDCCode": "63044-150-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (63044-150-01) ",
"NDC11Code": "63044-0150-01",
"ProductNDC": "63044-150",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prenatal Vitamins Plus",
"NonProprietaryName": "Vitamin A, Vitamin C, Vitamin D-3, Vitamin E, Vitamin B-1, Vitamin B-2, Niacin, Vitamin B-6, Calcium, Iron, Zinc, Copper",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160225",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Nnodum Pharmaceuticals",
"SubstanceName": ".ALPHA.-TOCOPHEROL ACETATE; ASCORBIC ACID; CALCIUM CARBONATE; CHOLECALCIFEROL; COPPER; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; VITAMIN A ACETATE; ZINC OXIDE",
"StrengthNumber": "10; 120; 200; 10; 2; 12; 27; 1700; 20; 10; 3; 1.84; 1200; 25",
"StrengthUnit": "mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Coagulation Factor Activity [PE], Inhibit Ovum Fertilization [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-12-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20160225",
"SamplePackage": "N"
},
{
"NDCCode": "63044-150-05",
"PackageDescription": "500 TABLET in 1 BOTTLE, PLASTIC (63044-150-05) ",
"NDC11Code": "63044-0150-05",
"ProductNDC": "63044-150",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prenatal Vitamins Plus",
"NonProprietaryName": "Vitamin A, Vitamin C, Vitamin D-3, Vitamin E, Vitamin B-1, Vitamin B-2, Niacin, Vitamin B-6, Calcium, Iron, Zinc, Copper",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160225",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Nnodum Pharmaceuticals",
"SubstanceName": ".ALPHA.-TOCOPHEROL ACETATE; ASCORBIC ACID; CALCIUM CARBONATE; CHOLECALCIFEROL; COPPER; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; VITAMIN A ACETATE; ZINC OXIDE",
"StrengthNumber": "10; 120; 200; 10; 2; 12; 27; 1700; 20; 10; 3; 1.84; 1200; 25",
"StrengthUnit": "mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Coagulation Factor Activity [PE], Inhibit Ovum Fertilization [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-12-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20160225",
"SamplePackage": "N"
},
{
"NDCCode": "63044-153-01",
"PackageDescription": "90 TABLET, COATED in 1 BOTTLE (63044-153-01)",
"NDC11Code": "63044-0153-01",
"ProductNDC": "63044-153",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Inatal Advance",
"NonProprietaryName": "Inatal Advance",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20050610",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Nnodum Pharmaceuticals",
"SubstanceName": "VITAMIN A; ASCORBIC ACID; CALCIUM CARBONATE; IRON PENTACARBONYL; CHOLECALCIFEROL; ALPHA-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; ZINC OXIDE; CUPRIC OXIDE; MAGNESIUM OXIDE; DOCUSATE SODIUM",
"StrengthNumber": "2700; 120; 200; 90; 400; 30; 3; 3.4; 20; 20; 1; 12; 25; 2; 30; 50",
"StrengthUnit": "[iU]/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Vitamin A [CS],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Calcium [CS],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Vitamin D [CS],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC],Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "INATAL ADVANCE ® is a multivitamin/multimineral nutritional supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. INATAL Advanced® can also be beneficial in improving the nutritional status of women prior to conception.",
"Description": "INATAL Advanced ® is a white, dye-free, oval shaped, oil-and-water soluble multivitamin/multimineral tablet which contains calcium carbonate and carbonyl iron. Each tablet contains. Vitamin A (as beta-carotene) . . . . . . . . . . . 2700 I.U. Vitamin C (ascorbic acid) . . . . . . . . . . . . . . 120 mg. Calcium (as calcium carbonate) . . . . . . . . . . 200 mg. Elemental Iron (as carbonyl iron) . . . . . . . . . . 90 mg. Vitamin D3 (cholecalciferol) . . . . . . . . . . . . 400 I.U. Vitamin E (dl-alpha tocopheryl acetate) . . . . . 30 I.U. Vitamin B1 (as thiamine mononitrate) . . . . . . . . 3 mg. Vitamin B2 (riboflavin, USP) . . . . . . . . . . . . . 3.4 mg. Niacinamide . . . . . . . . . . . . . . . . . . . . . . . . 20 mg. Vitamin B6 (as pyridoxine HCI, USP) . . . . . . . 20 mg. Folic Acid, USP . . . . . . . . . . . . . . . . . . . . . . . 1 mg. Vitamin B12 (cyanocobalamin) . . . . . . . . . . . 12 mcg. Zinc (as zinc oxide, USP) . . . . . . . . . . . . . . . . 25 mg. Copper (as cupric oxide) . . . . . . . . . . . . . . . . . 2 mg. Magnesium (as magnesium oxide, USP) . . . . . 30 mg. Docusate Sodium . . . . . . . . . . . . . . . . . . . . 50 mg. INACTIVE INGREDIENTS: Carnauba wax, crospovidone, ethyl vanillin, hydroxypropyl methylcellulose, magnesium stearate, polyethylene glycol, silicon dioxide, stearic acid, and titanium dioxide."
},
{
"NDCCode": "63044-153-64",
"PackageDescription": "9 BLISTER PACK in 1 BOX, UNIT-DOSE (63044-153-64) > 10 TABLET, COATED in 1 BLISTER PACK",
"NDC11Code": "63044-0153-64",
"ProductNDC": "63044-153",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Inatal Advance",
"NonProprietaryName": "Inatal Advance",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20050610",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Nnodum Pharmaceuticals",
"SubstanceName": "VITAMIN A; ASCORBIC ACID; CALCIUM CARBONATE; IRON PENTACARBONYL; CHOLECALCIFEROL; ALPHA-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; ZINC OXIDE; CUPRIC OXIDE; MAGNESIUM OXIDE; DOCUSATE SODIUM",
"StrengthNumber": "2700; 120; 200; 90; 400; 30; 3; 3.4; 20; 20; 1; 12; 25; 2; 30; 50",
"StrengthUnit": "[iU]/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Vitamin A [CS],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Calcium [CS],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Vitamin D [CS],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC],Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "INATAL ADVANCE ® is a multivitamin/multimineral nutritional supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. INATAL Advanced® can also be beneficial in improving the nutritional status of women prior to conception.",
"Description": "INATAL Advanced ® is a white, dye-free, oval shaped, oil-and-water soluble multivitamin/multimineral tablet which contains calcium carbonate and carbonyl iron. Each tablet contains. Vitamin A (as beta-carotene) . . . . . . . . . . . 2700 I.U. Vitamin C (ascorbic acid) . . . . . . . . . . . . . . 120 mg. Calcium (as calcium carbonate) . . . . . . . . . . 200 mg. Elemental Iron (as carbonyl iron) . . . . . . . . . . 90 mg. Vitamin D3 (cholecalciferol) . . . . . . . . . . . . 400 I.U. Vitamin E (dl-alpha tocopheryl acetate) . . . . . 30 I.U. Vitamin B1 (as thiamine mononitrate) . . . . . . . . 3 mg. Vitamin B2 (riboflavin, USP) . . . . . . . . . . . . . 3.4 mg. Niacinamide . . . . . . . . . . . . . . . . . . . . . . . . 20 mg. Vitamin B6 (as pyridoxine HCI, USP) . . . . . . . 20 mg. Folic Acid, USP . . . . . . . . . . . . . . . . . . . . . . . 1 mg. Vitamin B12 (cyanocobalamin) . . . . . . . . . . . 12 mcg. Zinc (as zinc oxide, USP) . . . . . . . . . . . . . . . . 25 mg. Copper (as cupric oxide) . . . . . . . . . . . . . . . . . 2 mg. Magnesium (as magnesium oxide, USP) . . . . . 30 mg. Docusate Sodium . . . . . . . . . . . . . . . . . . . . 50 mg. INACTIVE INGREDIENTS: Carnauba wax, crospovidone, ethyl vanillin, hydroxypropyl methylcellulose, magnesium stearate, polyethylene glycol, silicon dioxide, stearic acid, and titanium dioxide."
},
{
"NDCCode": "63044-154-01",
"PackageDescription": "100 TABLET, COATED in 1 BOTTLE (63044-154-01)",
"NDC11Code": "63044-0154-01",
"ProductNDC": "63044-154",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Inatal Ultra",
"NonProprietaryName": "Inatal Ultra",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20050620",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Nnodum Pharmaceuticals",
"SubstanceName": "VITAMIN A; ASCORBIC ACID; CALCIUM CITRATE; IRON PENTACARBONYL; CHOLECALCIFEROL; ALPHA-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; POTASSIUM IODIDE; ZINC OXIDE; CUPRIC OXIDE; DOCUSATE SODIUM",
"StrengthNumber": "2700; 120; 200; 90; 400; 30; 3; 3.4; 20; 20; 1; 12; 150; 25; 2; 50",
"StrengthUnit": "[iU]/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Vitamin A [CS],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Calcium [CS],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Vitamin D [CS],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "INATAL Ultra ® is a multivitamin/multimineral nutritional supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. Ultra NatalCare® can also be beneficial in improving the nutritional status of women prior to conception.",
"Description": "INATAL Ultra is a white, dye free, oval oil-and-water-soluble multivitamin/multimineral tablet with calcium citrate and carbonyl iron. Each tablet contains. Vitamin A* . . . . . . . . . . . . . . . . . . . . . . . 2700 I.U. Vitamin C (Ascorbic Acid) . . . . . . . . . . . . . . 120 mg. Calcium (Calcium Citrate) . . . . . . . . . . . . . 200 mg. Elemental Iron (Carbonyl Iron) . . . . . . . . . . . 90 mg. Vitamin D3 (Cholecalciferol) . . . . . . . . . . . . 400 I.U. Vitamin E (dl-Alpha Tocopheryl Acetate) . . . . . 30 I.U. Vitamin B1 (Thiamine Mononitrate) . . . . . . . . . 3 mg. Vitamin B2 (Riboflavin) . . . . . . . . . . . . . . . . 3.4 mg. Niacinamide . . . . . . . . . . . . . . . . . . . . . . . . 20 mg. Vitamin B6 (Pyridoxine HCI) . . . . . . . . . . . . . 20 mg. Folic Acid . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 mg. Vitamin B12 (Cyanocobalamin) . . . . . . . . . . 12 mcg. Iodine (Potassium Iodide) . . . . . . . . . . . . . 150 mcg. Zinc (Zinc Oxide) . . . . . . . . . . . . . . . . . . . . . 25 mg. Copper (Cupric Oxide) . . . . . . . . . . . . . . . . . 2 mg. Docusate Sodium . . . . . . . . . . . . . . . . . . . . 50 mg. *Input as Vitamin A palmitate and beta carotene."
},
{
"NDCCode": "63044-154-63",
"PackageDescription": "10 BLISTER PACK in 1 BOX, UNIT-DOSE (63044-154-63) > 10 TABLET, COATED in 1 BLISTER PACK",
"NDC11Code": "63044-0154-63",
"ProductNDC": "63044-154",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Inatal Ultra",
"NonProprietaryName": "Inatal Ultra",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20050620",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Nnodum Pharmaceuticals",
"SubstanceName": "VITAMIN A; ASCORBIC ACID; CALCIUM CITRATE; IRON PENTACARBONYL; CHOLECALCIFEROL; ALPHA-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; POTASSIUM IODIDE; ZINC OXIDE; CUPRIC OXIDE; DOCUSATE SODIUM",
"StrengthNumber": "2700; 120; 200; 90; 400; 30; 3; 3.4; 20; 20; 1; 12; 150; 25; 2; 50",
"StrengthUnit": "[iU]/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Vitamin A [CS],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Calcium [CS],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Vitamin D [CS],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "INATAL Ultra ® is a multivitamin/multimineral nutritional supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. Ultra NatalCare® can also be beneficial in improving the nutritional status of women prior to conception.",
"Description": "INATAL Ultra is a white, dye free, oval oil-and-water-soluble multivitamin/multimineral tablet with calcium citrate and carbonyl iron. Each tablet contains. Vitamin A* . . . . . . . . . . . . . . . . . . . . . . . 2700 I.U. Vitamin C (Ascorbic Acid) . . . . . . . . . . . . . . 120 mg. Calcium (Calcium Citrate) . . . . . . . . . . . . . 200 mg. Elemental Iron (Carbonyl Iron) . . . . . . . . . . . 90 mg. Vitamin D3 (Cholecalciferol) . . . . . . . . . . . . 400 I.U. Vitamin E (dl-Alpha Tocopheryl Acetate) . . . . . 30 I.U. Vitamin B1 (Thiamine Mononitrate) . . . . . . . . . 3 mg. Vitamin B2 (Riboflavin) . . . . . . . . . . . . . . . . 3.4 mg. Niacinamide . . . . . . . . . . . . . . . . . . . . . . . . 20 mg. Vitamin B6 (Pyridoxine HCI) . . . . . . . . . . . . . 20 mg. Folic Acid . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 mg. Vitamin B12 (Cyanocobalamin) . . . . . . . . . . 12 mcg. Iodine (Potassium Iodide) . . . . . . . . . . . . . 150 mcg. Zinc (Zinc Oxide) . . . . . . . . . . . . . . . . . . . . . 25 mg. Copper (Cupric Oxide) . . . . . . . . . . . . . . . . . 2 mg. Docusate Sodium . . . . . . . . . . . . . . . . . . . . 50 mg. *Input as Vitamin A palmitate and beta carotene."
},
{
"NDCCode": "63044-198-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (63044-198-01)",
"NDC11Code": "63044-0198-01",
"ProductNDC": "63044-198",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Iferex 150 Forte",
"NonProprietaryName": "Iron, Cyanocobalamin And Folic Acid",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20071028",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Nnodum Pharmaceuticals",
"SubstanceName": "IRON; CYANOCOBALAMIN; FOLIC ACID",
"StrengthNumber": "150; 25; 1",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-04-26",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "63044-203-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (63044-203-01)",
"NDC11Code": "63044-0203-01",
"ProductNDC": "63044-203",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Iferex 150",
"NonProprietaryName": "Polysaccharide-iron Complex",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20071028",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Nnodum Pharmaceuticals",
"SubstanceName": "IRON",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-04-20",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "63044-203-61",
"PackageDescription": "10 BLISTER PACK in 1 BOX, UNIT-DOSE (63044-203-61) > 10 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "63044-0203-61",
"ProductNDC": "63044-203",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Iferex 150",
"NonProprietaryName": "Polysaccharide-iron Complex",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20071028",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Nnodum Pharmaceuticals",
"SubstanceName": "IRON",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-04-20",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "63044-401-01",
"PackageDescription": "30 CAPSULE, GELATIN COATED in 1 BOTTLE (63044-401-01)",
"NDC11Code": "63044-0401-01",
"ProductNDC": "63044-401",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vitamin D3dietary Supplemen",
"ProprietaryNameSuffix": "Dietary Supplement",
"NonProprietaryName": "Cholecalciferol",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120114",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Nnodum Pharmaceuticals",
"SubstanceName": "CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL",
"StrengthNumber": ".25; 5",
"StrengthUnit": "mg/1; [iU]/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "63044-404-20",
"PackageDescription": "140 g in 1 TUBE (63044-404-20)",
"NDC11Code": "63044-0404-20",
"ProductNDC": "63044-404",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ammonium Lactate",
"NonProprietaryName": "Ammonium Lactate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20071230",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "Nnodum Pharmaceuticals",
"SubstanceName": "AMMONIUM LACTATE",
"StrengthNumber": "17",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Ammonium Lactate Cream is indicated for the treatment of dry, scaly skin (xerosis) and ichthyosis vulgaris and for temporary relief of itching associated with these conditions.",
"Description": "Ammonium Lactate Cream, 12% is a formulation of 12% lactic acid neutralized with ammonium hydroxide, as ammonium lactate with a pH of 4.4-5.4. Ingredients: Ammonium Lactate Cream, 12% also contains cetyl alcohol, glycerin, glyceryl stearate, light mineral oil, magnesium aluminum silicate, methyl and propyl parabens, Carbomer 940, PEG-100 stearate, polysorbate 85, triethanolamine, propylene glycol, Petrolatum and Sodium PCA, stearic acid and water. Lactic acid is a racemic mixture of 2-hydroxypropanoic acid and has the following structural formula."
},
{
"NDCCode": "63044-484-09",
"PackageDescription": "225 g in 1 BOTTLE, PLASTIC (63044-484-09)",
"NDC11Code": "63044-0484-09",
"ProductNDC": "63044-484",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ammonium Lactate",
"NonProprietaryName": "Ammonium Lactate",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20071230",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "Nnodum Pharmaceuticals",
"SubstanceName": "AMMONIUM LACTATE",
"StrengthNumber": "17",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Ammonium Lactate Lotion is indicated for the treatment of dry, scaly skin (xerosis) and ichthyosis vulgaris and for temporary relief of itching associated with these conditions.",
"Description": "Ammonium Lactate Lotion, 12% is a formulation of 12% lactic acid neutralized with ammonium hydroxide, as ammonium lactate with a pH of 4.4-5.4. Ingredients: Ammonium Lactate Lotion, 12% also contains cetyl alcohol, glycerin, glyceryl stearate, light mineral oil, magnesium aluminum silicate, methyl and propyl parabens, Carbomer 940, PEG-100 stearate, polysorbate 85, triethanolamine, propylene glycol, Petrolatum and Sodium PCA, stearic acid and water. Lactic acid is a racemic mixture of 2-hydroxypropanoic acid and has the following structural formula."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>63044-631-19</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 BOX (63044-631-19) / 1 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>63044-0631-19</NDC11Code>
<ProductNDC>63044-631</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hematogen</ProprietaryName>
<NonProprietaryName>Ferrous Fumarate, Ascorbic Acid, Intrinsic Factor , Cyanocobalamin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070510</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Nnodum Pharmaceuticals</LabelerName>
<SubstanceName>ASCORBIC ACID; CYANOCOBALAMIN; FERROUS FUMARATE; INTRINSIC FACTOR</SubstanceName>
<StrengthNumber>250; 10; 66; 100</StrengthNumber>
<StrengthUnit>mg/1; ug/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Ascorbic Acid [CS], Vitamin B 12 [CS], Vitamin B12 [EPC], Vitamin C [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070510</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the treatment of all anemias responsive to oral iron therapy, such as hypochromic anemia associated with pregnancy, chronic or acute blood loss, dietary restriction, metabolic disease and post-surgical convalescence.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61786-631-19</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61786-631-19)</PackageDescription>
<NDC11Code>61786-0631-19</NDC11Code>
<ProductNDC>61786-631</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Tartrate</ProprietaryName>
<NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160322</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200981</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-10-12</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>69842-631-19</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (69842-631-19) / 9.4 g in 1 TUBE</PackageDescription>
<NDC11Code>69842-0631-19</NDC11Code>
<ProductNDC>69842-631</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>4x Medicated Toothache And Gum Cream</ProprietaryName>
<NonProprietaryName>Benzocaine</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200605</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M022</ApplicationNumber>
<LabelerName>CVS</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE; ZINC CHLORIDE; BENZOCAINE; MENTHOL, UNSPECIFIED FORM</SubstanceName>
<StrengthNumber>.13; .15; 20; .26</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g; g/100g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200605</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the temporary relief of pain due to toothaches * to help protect against infection or minor oral irritation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0074-1017-14</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (0074-1017-14) / 1 KIT in 1 BLISTER PACK * 7 CAPSULE in 1 BLISTER PACK * 7 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00074-1017-14</NDC11Code>
<ProductNDC>0074-1017</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oriahnn</ProprietaryName>
<NonProprietaryName>Elagolix And Estradiol And Norethisterone</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20200529</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213388</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200924</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>ORIAHNN is indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. Limitation of Use. Use of ORIAHNN should be limited to 24 months due to the risk of continued bone loss, which may not be reversible [see Dosage and Administration (2.1) and Warnings and Precautions (5.2)].</IndicationAndUsage>
<Description>ORIAHNN consists of two capsules: one to be taken orally in the morning (AM) and one to be taken orally in the evening (PM). The AM capsule is white and yellow and contains 300 mg elagolix (equivalent to 310.4 mg of elagolix sodium), 1 mg estradiol, and 0.5 mg norethindrone acetate. The PM capsule is white and light blue and contains 300 mg of elagolix (equivalent to 310 mg of elagolix sodium). Elagolix. Elagolix sodium is the sodium salt of the active moiety elagolix, a nonpeptide small molecule, GnRH receptor antagonist. Elagolix sodium is chemically described as sodium 4-({(1R)-2-[5-(2-fluoro-3-methoxyphenyl)-3-{[2-fluoro-6-(trifluoromethyl)phenyl]methyl}-4-methyl-2,6-dioxo-3,6-dihydropyrimidin-1(2H)-yl]-1-phenylethyl}amino)butanoate. Elagolix sodium has a molecular formula of C32H29F5N3O5Na and a molecular weight of 653.58. Elagolix free acid has a molecular formula of C32H30F5N3O5 and a molecular weight of 631.60. Elagolix sodium has the following structural formula:. Elagolix sodium is a white to off-white to light yellow powder and is freely soluble in water. Estradiol. Estradiol (E2), an estrogen, is a white or almost white crystalline powder. Its chemical name is estra-1,3,5(10)-triene-3,17β-diol with the molecular formula of C18H24O2, and molecular weight of 272.38. The structural formula of E2 is as follows:. Norethindrone acetate. Norethindrone acetate (NETA), a progestin, is a white or yellowish white crystalline powder. Its chemical name is 17β-acetoxy-19-nor-17α-pregn-4-en-20-yn-3-one with the molecular formula of C22H28O3 and molecular weight of 340.46. ORIAHNN morning (AM) capsules contain the following inactive ingredients: anhydrous sodium carbonate, polyethylene glycol 3350, crospovidone, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, purified water, lactose monohydrate, starch (corn), copovidone, talc, hypromellose, triacetin, and gelatin capsule shell. The capsule shell contains the following ingredients: FD&C Red #40, FD&C Yellow #5 [see Warnings and Precautions (5.12)], FD&C Yellow #6, titanium dioxide, gelatin, and printing ink (shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water). ORIAHNN evening (PM) capsules contain the following inactive ingredients: anhydrous sodium carbonate, polyethylene glycol 3350, crospovidone, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, purified water, and gelatin capsule shell. The capsule shell contains the following ingredients: FD&C Blue #2, FDA/E172 yellow iron oxide, titanium dioxide, gelatin, and printing ink (shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water).</Description>
</NDC>
<NDC>
<NDCCode>0074-1017-56</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (0074-1017-56) / 1 KIT in 1 BLISTER PACK * 7 CAPSULE in 1 BLISTER PACK * 7 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00074-1017-56</NDC11Code>
<ProductNDC>0074-1017</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oriahnn</ProprietaryName>
<NonProprietaryName>Elagolix And Estradiol And Norethisterone</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20200529</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213388</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200529</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ORIAHNN is indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. Limitation of Use. Use of ORIAHNN should be limited to 24 months due to the risk of continued bone loss, which may not be reversible [see Dosage and Administration (2.1) and Warnings and Precautions (5.2)].</IndicationAndUsage>
<Description>ORIAHNN consists of two capsules: one to be taken orally in the morning (AM) and one to be taken orally in the evening (PM). The AM capsule is white and yellow and contains 300 mg elagolix (equivalent to 310.4 mg of elagolix sodium), 1 mg estradiol, and 0.5 mg norethindrone acetate. The PM capsule is white and light blue and contains 300 mg of elagolix (equivalent to 310 mg of elagolix sodium). Elagolix. Elagolix sodium is the sodium salt of the active moiety elagolix, a nonpeptide small molecule, GnRH receptor antagonist. Elagolix sodium is chemically described as sodium 4-({(1R)-2-[5-(2-fluoro-3-methoxyphenyl)-3-{[2-fluoro-6-(trifluoromethyl)phenyl]methyl}-4-methyl-2,6-dioxo-3,6-dihydropyrimidin-1(2H)-yl]-1-phenylethyl}amino)butanoate. Elagolix sodium has a molecular formula of C32H29F5N3O5Na and a molecular weight of 653.58. Elagolix free acid has a molecular formula of C32H30F5N3O5 and a molecular weight of 631.60. Elagolix sodium has the following structural formula:. Elagolix sodium is a white to off-white to light yellow powder and is freely soluble in water. Estradiol. Estradiol (E2), an estrogen, is a white or almost white crystalline powder. Its chemical name is estra-1,3,5(10)-triene-3,17β-diol with the molecular formula of C18H24O2, and molecular weight of 272.38. The structural formula of E2 is as follows:. Norethindrone acetate. Norethindrone acetate (NETA), a progestin, is a white or yellowish white crystalline powder. Its chemical name is 17β-acetoxy-19-nor-17α-pregn-4-en-20-yn-3-one with the molecular formula of C22H28O3 and molecular weight of 340.46. ORIAHNN morning (AM) capsules contain the following inactive ingredients: anhydrous sodium carbonate, polyethylene glycol 3350, crospovidone, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, purified water, lactose monohydrate, starch (corn), copovidone, talc, hypromellose, triacetin, and gelatin capsule shell. The capsule shell contains the following ingredients: FD&C Red #40, FD&C Yellow #5 [see Warnings and Precautions (5.12)], FD&C Yellow #6, titanium dioxide, gelatin, and printing ink (shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water). ORIAHNN evening (PM) capsules contain the following inactive ingredients: anhydrous sodium carbonate, polyethylene glycol 3350, crospovidone, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, purified water, and gelatin capsule shell. The capsule shell contains the following ingredients: FD&C Blue #2, FDA/E172 yellow iron oxide, titanium dioxide, gelatin, and printing ink (shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water).</Description>
</NDC>
<NDC>
<NDCCode>42858-631-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42858-631-01) </PackageDescription>
<NDC11Code>42858-0631-01</NDC11Code>
<ProductNDC>42858-631</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ms Contin</ProprietaryName>
<NonProprietaryName>Morphine Sulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170515</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019516</ApplicationNumber>
<LabelerName>Rhodes Pharmaceuticals LLC</LabelerName>
<SubstanceName>MORPHINE SULFATE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>MS CONTIN is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use: 1 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.2)], reserve opioid analgesics, including MS CONTIN, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 MS CONTIN is not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
<Description>MS CONTIN (morphine sulfate extended-release tablets) is for oral use and contains morphine sulfate, an opioid agonist. Each tablet contains the following inactive ingredients common to all strengths: cetostearyl alcohol, hydroxyethyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, talc, and titanium dioxide. The tablet strengths describe the amount of morphine per tablet as the pentahydrated sulfate salt (morphine sulfate). The 15 mg tablets also contain: FD&C Blue No. 2, lactose, polysorbate 80. The 30 mg tablets also contain: D&C Red No. 7, FD&C Blue No. 1, lactose, polysorbate 80. The 60 mg tablets also contain: D&C Red No. 30, D&C Yellow No. 10, hydroxypropyl cellulose, lactose. Morphine sulfate is an odorless, white, crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its molecular weight is 758.83 and its structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>50268-631-15</NDCCode>
<PackageDescription>50 BLISTER PACK in 1 BOX (50268-631-15) / 1 TABLET in 1 BLISTER PACK (50268-631-11) </PackageDescription>
<NDC11Code>50268-0631-15</NDC11Code>
<ProductNDC>50268-631</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quetiapine Fumarate</ProprietaryName>
<NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160526</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201504</ApplicationNumber>
<LabelerName>AvPAK</LabelerName>
<SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160526</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Quetiapine is an atypical antipsychotic indicated for the treatment of. · Schizophrenia (1.1). · Bipolar I disorder manic episodes (1.2). · Bipolar disorder, depressive episodes (1.2).</IndicationAndUsage>
<Description>Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl) ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C 42H 50N 6O 4S 2C 4H 4O 4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is:. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablets, USP is supplied for oral administration as 25 mg (round peach), 50 mg (round, white), 100 mg (round yellow), 150 mg (round, off white to light yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are povidone, dibasic dicalcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, hypromellose, polyethylene glycol and titanium dioxide. The 25 mg tablets contain red iron oxide and yellow iron oxide and the 100 mg, 150 mg and 400 mg tablets contain only yellow iron oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate USP equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate USP equivalent to 100 mg quetiapine.Each 150 mg tablet contains 172.70 mg of quetiapine fumarate USP equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.27 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.40 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.54 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine.</Description>
</NDC>
<NDC>
<NDCCode>51150-631-01</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (51150-631-01) / 50 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>51150-0631-01</NDC11Code>
<ProductNDC>51150-631</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lancome Paris Uv Expert Supra Screen Mineral Invisible Sunscreen Spf 50 Serum</ProprietaryName>
<NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>SICOS ET CIE</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>26.6; 153.5</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging cause by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>51150-631-02</NDCCode>
<PackageDescription>1 JAR in 1 CARTON (51150-631-02) / 30 mL in 1 JAR</PackageDescription>
<NDC11Code>51150-0631-02</NDC11Code>
<ProductNDC>51150-631</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lancome Paris Uv Expert Supra Screen Mineral Invisible Sunscreen Spf 50 Serum</ProprietaryName>
<NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>SICOS ET CIE</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>26.6; 153.5</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging cause by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55700-631-10</NDCCode>
<PackageDescription>10 TABLET, FILM COATED in 1 BOTTLE (55700-631-10) </PackageDescription>
<NDC11Code>55700-0631-10</NDC11Code>
<ProductNDC>55700-631</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ondansetron Hydrochloride</ProprietaryName>
<NonProprietaryName>Ondansetron Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180525</StartMarketingDate>
<EndMarketingDate>20280131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078539</ApplicationNumber>
<LabelerName>Quality Care Products LLC</LabelerName>
<SubstanceName>ONDANSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180525</StartMarketingDatePackage>
<EndMarketingDatePackage>20270531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with. Ondansetron tablets are also indicated for the prevention of postoperative nausea and/or vomiting.</IndicationAndUsage>
<Description>The active ingredient in ondansetron tablets, USP is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula: The molecular formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.9. Ondansetron hydrochloride USP (dihydrate) is a white to off-white powder that is soluble in water and normal saline. Ondansetron tablets, USP for oral administration contain ondansetron hydrochloride USP (dihydrate) equivalent to 4 mg or 8 mg or 24 mg of ondansetron. Each film-coated tablet also contains the inactive ingredients anhydrous lactose, microcrystalline cellulose, pregelatinized starch (maize), magnesium stearate, triacetin, titanium dioxide and hypromellose. In addition 8 mg tablet also contains iron oxide yellow and 24 mg tablet also contains iron oxide red. Meets USP dissolution test 6.</Description>
</NDC>
<NDC>
<NDCCode>55700-631-20</NDCCode>
<PackageDescription>20 TABLET, FILM COATED in 1 BOTTLE (55700-631-20) </PackageDescription>
<NDC11Code>55700-0631-20</NDC11Code>
<ProductNDC>55700-631</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ondansetron Hydrochloride</ProprietaryName>
<NonProprietaryName>Ondansetron Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180525</StartMarketingDate>
<EndMarketingDate>20280131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078539</ApplicationNumber>
<LabelerName>Quality Care Products LLC</LabelerName>
<SubstanceName>ONDANSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180525</StartMarketingDatePackage>
<EndMarketingDatePackage>20270531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with. Ondansetron tablets are also indicated for the prevention of postoperative nausea and/or vomiting.</IndicationAndUsage>
<Description>The active ingredient in ondansetron tablets, USP is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula: The molecular formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.9. Ondansetron hydrochloride USP (dihydrate) is a white to off-white powder that is soluble in water and normal saline. Ondansetron tablets, USP for oral administration contain ondansetron hydrochloride USP (dihydrate) equivalent to 4 mg or 8 mg or 24 mg of ondansetron. Each film-coated tablet also contains the inactive ingredients anhydrous lactose, microcrystalline cellulose, pregelatinized starch (maize), magnesium stearate, triacetin, titanium dioxide and hypromellose. In addition 8 mg tablet also contains iron oxide yellow and 24 mg tablet also contains iron oxide red. Meets USP dissolution test 6.</Description>
</NDC>
<NDC>
<NDCCode>55700-631-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (55700-631-30) </PackageDescription>
<NDC11Code>55700-0631-30</NDC11Code>
<ProductNDC>55700-631</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ondansetron Hydrochloride</ProprietaryName>
<NonProprietaryName>Ondansetron Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180525</StartMarketingDate>
<EndMarketingDate>20280131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078539</ApplicationNumber>
<LabelerName>Quality Care Products LLC</LabelerName>
<SubstanceName>ONDANSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180525</StartMarketingDatePackage>
<EndMarketingDatePackage>20280131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with. Ondansetron tablets are also indicated for the prevention of postoperative nausea and/or vomiting.</IndicationAndUsage>
<Description>The active ingredient in ondansetron tablets, USP is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula: The molecular formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.9. Ondansetron hydrochloride USP (dihydrate) is a white to off-white powder that is soluble in water and normal saline. Ondansetron tablets, USP for oral administration contain ondansetron hydrochloride USP (dihydrate) equivalent to 4 mg or 8 mg or 24 mg of ondansetron. Each film-coated tablet also contains the inactive ingredients anhydrous lactose, microcrystalline cellulose, pregelatinized starch (maize), magnesium stearate, triacetin, titanium dioxide and hypromellose. In addition 8 mg tablet also contains iron oxide yellow and 24 mg tablet also contains iron oxide red. Meets USP dissolution test 6.</Description>
</NDC>
<NDC>
<NDCCode>63323-631-50</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (63323-631-50) / 50 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>63323-0631-50</NDC11Code>
<ProductNDC>63323-631</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Leucovorin Calcium</ProprietaryName>
<NonProprietaryName>Leucovorin Calcium</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20180727</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207226</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>LEUCOVORIN CALCIUM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Folate Analog [EPC], Folic Acid [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180727</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Leucovorin calcium rescue is indicated after high dose methotrexate therapy in osteosarcoma. Leucovorin calcium is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosages of folic acid antagonists. Leucovorin calcium is indicated in the treatment of megaloblastic anemias due to folic acid deficiency when oral therapy is not feasible. Leucovorin is also indicated for use in combination with 5-fluorouracil to prolong survival in the palliative treatment of patients with advanced colorectal cancer. Leucovorin should not be mixed in the same infusion as 5-fluorouracil because a precipitate may form.</IndicationAndUsage>
<Description>Leucovorin is one of several active, chemically reduced derivatives of folic acid. It is useful as an antidote to drugs which act as folic acid antagonists.Also known as folinic acid, Citrovorum factor, or 5-formyl-5,6,7,8-tetrahydrofolic acid, this compound has the chemical designation of Calcium N-[p-[[[(6RS)-2-amino-5-formyl-5,6,7,8-tetrahydro-4-hydroxy-6-pteridinyl]methyl]amino]benzoyl]-L-glutamate (1:1). The structural formula of leucovorin calcium is. C20H21CaN7O7 M.W=511.50 Leucovorin Calcium Injection USP is a sterile, preservative-free solution indicated for intramuscular (IM) or intravenous (IV) administration in a 50 mL single-dose vial. Each mL contains leucovorin calcium equivalent to 10 mg Leucovorin, USP; 8 mg sodium chloride; sodium hydroxide and/or hydrochloric acid for pH adjustment (pH 6.5 to 8.5). There is 0.004 mEq of calcium per mg of leucovorin. Solution contains no bacteriostat or antimicrobial agents. One milligram of leucovorin calcium contains 0.002 mmol of leucovorin and 0.002 mmol of calcium.</Description>
</NDC>
<NDC>
<NDCCode>69097-579-67</NDCCode>
<PackageDescription>1 DOSE PACK in 1 CARTON (69097-579-67) / 1 GRANULE, FOR SOLUTION in 1 DOSE PACK</PackageDescription>
<NDC11Code>69097-0579-67</NDC11Code>
<ProductNDC>69097-579</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fosfomycin Tromethamine</ProprietaryName>
<NonProprietaryName>Fosfomycin Tromethamine</NonProprietaryName>
<DosageFormName>GRANULE, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220126</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211881</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>FOSFOMYCIN TROMETHAMINE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220126</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fosfomycin tromethamine granules for oral solution is indicated only for the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of Escherichia coli and Enterococcus faecalis. Fosfomycin tromethamine granules for oral solution is not indicated for the treatment of pyelonephritis or perinephric abscess. If persistence or reappearance of bacteriuria occurs after treatment with fosfomycin tromethamine granules for oral solution, other therapeutic agents should be selected. (See PRECAUTIONS and CLINICAL STUDIES sections.).</IndicationAndUsage>
<Description>Fosfomycin tromethamine granules for oral solution contains fosfomycin tromethamine, a synthetic, broad spectrum, bactericidal antibiotic for oral administration. It is available as a single-dose sachet which contains white granules consisting of 5.631 grams of fosfomycin tromethamine (equivalent to 3 grams of fosfomycin), and the following inactive ingredients: mandarin flavor, orange powder flavor, saccharin, and sucrose. The contents of the sachet must be dissolved in water. Fosfomycin tromethamine, a phosphonic acid derivative, is available as (1R,2S)-(1,2-epoxypropyl)phosphonic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1). It is a white or almost white, hygroscopic powder with a molecular weight of 259.19. Its empirical formula is C3H7O4P.C4H11NO3, and its chemical structure is as follows:.</Description>
</NDC>
<NDC>
<NDCCode>82046-631-01</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (82046-631-01) / 50 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>82046-0631-01</NDC11Code>
<ProductNDC>82046-631</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lancome Paris Uv Expert Supra Screen Mineral Invisible Sunscreen Spf 50 Serum</ProprietaryName>
<NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>L�Oreal USA Products Inc.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>26.6; 153.5</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging cause by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>82046-631-02</NDCCode>
<PackageDescription>1 JAR in 1 CARTON (82046-631-02) / 30 mL in 1 JAR</PackageDescription>
<NDC11Code>82046-0631-02</NDC11Code>
<ProductNDC>82046-631</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lancome Paris Uv Expert Supra Screen Mineral Invisible Sunscreen Spf 50 Serum</ProprietaryName>
<NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>L�Oreal USA Products Inc.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>26.6; 153.5</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging cause by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84515-631-01</NDCCode>
<PackageDescription>15 mL in 1 BOX (84515-631-01) </PackageDescription>
<NDC11Code>84515-0631-01</NDC11Code>
<ProductNDC>84515-631</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rosemary Oilfor For Hair And Scalp</ProprietaryName>
<NonProprietaryName>Rosemary Oilfor For Hair And Scalp</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241022</StartMarketingDate>
<EndMarketingDate>20311231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M032</ApplicationNumber>
<LabelerName>Yiwu Xinqian E Commerce Co Ltd</LabelerName>
<SubstanceName>MINOXIDIL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20241022</StartMarketingDatePackage>
<EndMarketingDatePackage>20311231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63044-030-60</NDCCode>
<PackageDescription>56.6 g in 1 TUBE (63044-030-60) </PackageDescription>
<NDC11Code>63044-0030-60</NDC11Code>
<ProductNDC>63044-030</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ziks Arthritis Pain Relief</ProprietaryName>
<NonProprietaryName>Ziks Arthritis Pain Relief</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19991110</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Nnodum Pharmaceuticals</LabelerName>
<SubstanceName>METHYL SALICYLATE; MENTHOL; CAPSAICIN</SubstanceName>
<StrengthNumber>6.79; .566; .014</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19991110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of minor aches and pain of muscles and joints associated with arthritis, simple backache, strains and sprains. *Products containing purified capsaicin are most recommended by doctors and pharmacists.</IndicationAndUsage>
<Description>Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a physician. A passing burning sensation may occur upon application, but generally disappears in several days. Application schedules of less than 3 to 4 times a day may not provide optimum pain relief ant the burning sensation may persist. WASH HANDS WITH SOAP AND WATER AFTER APPLYING UNLESS TREATING HANDS.</Description>
</NDC>
<NDC>
<NDCCode>63044-150-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (63044-150-01) </PackageDescription>
<NDC11Code>63044-0150-01</NDC11Code>
<ProductNDC>63044-150</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prenatal Vitamins Plus</ProprietaryName>
<NonProprietaryName>Vitamin A, Vitamin C, Vitamin D-3, Vitamin E, Vitamin B-1, Vitamin B-2, Niacin, Vitamin B-6, Calcium, Iron, Zinc, Copper</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160225</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Nnodum Pharmaceuticals</LabelerName>
<SubstanceName>.ALPHA.-TOCOPHEROL ACETATE; ASCORBIC ACID; CALCIUM CARBONATE; CHOLECALCIFEROL; COPPER; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; VITAMIN A ACETATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>10; 120; 200; 10; 2; 12; 27; 1700; 20; 10; 3; 1.84; 1200; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Coagulation Factor Activity [PE], Inhibit Ovum Fertilization [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-12-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160225</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63044-150-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE, PLASTIC (63044-150-05) </PackageDescription>
<NDC11Code>63044-0150-05</NDC11Code>
<ProductNDC>63044-150</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prenatal Vitamins Plus</ProprietaryName>
<NonProprietaryName>Vitamin A, Vitamin C, Vitamin D-3, Vitamin E, Vitamin B-1, Vitamin B-2, Niacin, Vitamin B-6, Calcium, Iron, Zinc, Copper</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160225</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Nnodum Pharmaceuticals</LabelerName>
<SubstanceName>.ALPHA.-TOCOPHEROL ACETATE; ASCORBIC ACID; CALCIUM CARBONATE; CHOLECALCIFEROL; COPPER; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; VITAMIN A ACETATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>10; 120; 200; 10; 2; 12; 27; 1700; 20; 10; 3; 1.84; 1200; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Coagulation Factor Activity [PE], Inhibit Ovum Fertilization [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-12-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160225</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63044-153-01</NDCCode>
<PackageDescription>90 TABLET, COATED in 1 BOTTLE (63044-153-01)</PackageDescription>
<NDC11Code>63044-0153-01</NDC11Code>
<ProductNDC>63044-153</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Inatal Advance</ProprietaryName>
<NonProprietaryName>Inatal Advance</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050610</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Nnodum Pharmaceuticals</LabelerName>
<SubstanceName>VITAMIN A; ASCORBIC ACID; CALCIUM CARBONATE; IRON PENTACARBONYL; CHOLECALCIFEROL; ALPHA-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; ZINC OXIDE; CUPRIC OXIDE; MAGNESIUM OXIDE; DOCUSATE SODIUM</SubstanceName>
<StrengthNumber>2700; 120; 200; 90; 400; 30; 3; 3.4; 20; 20; 1; 12; 25; 2; 30; 50</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Vitamin A [CS],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Calcium [CS],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Vitamin D [CS],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC],Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>INATAL ADVANCE ® is a multivitamin/multimineral nutritional supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. INATAL Advanced® can also be beneficial in improving the nutritional status of women prior to conception.</IndicationAndUsage>
<Description>INATAL Advanced ® is a white, dye-free, oval shaped, oil-and-water soluble multivitamin/multimineral tablet which contains calcium carbonate and carbonyl iron. Each tablet contains. Vitamin A (as beta-carotene) . . . . . . . . . . . 2700 I.U. Vitamin C (ascorbic acid) . . . . . . . . . . . . . . 120 mg. Calcium (as calcium carbonate) . . . . . . . . . . 200 mg. Elemental Iron (as carbonyl iron) . . . . . . . . . . 90 mg. Vitamin D3 (cholecalciferol) . . . . . . . . . . . . 400 I.U. Vitamin E (dl-alpha tocopheryl acetate) . . . . . 30 I.U. Vitamin B1 (as thiamine mononitrate) . . . . . . . . 3 mg. Vitamin B2 (riboflavin, USP) . . . . . . . . . . . . . 3.4 mg. Niacinamide . . . . . . . . . . . . . . . . . . . . . . . . 20 mg. Vitamin B6 (as pyridoxine HCI, USP) . . . . . . . 20 mg. Folic Acid, USP . . . . . . . . . . . . . . . . . . . . . . . 1 mg. Vitamin B12 (cyanocobalamin) . . . . . . . . . . . 12 mcg. Zinc (as zinc oxide, USP) . . . . . . . . . . . . . . . . 25 mg. Copper (as cupric oxide) . . . . . . . . . . . . . . . . . 2 mg. Magnesium (as magnesium oxide, USP) . . . . . 30 mg. Docusate Sodium . . . . . . . . . . . . . . . . . . . . 50 mg. INACTIVE INGREDIENTS: Carnauba wax, crospovidone, ethyl vanillin, hydroxypropyl methylcellulose, magnesium stearate, polyethylene glycol, silicon dioxide, stearic acid, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>63044-153-64</NDCCode>
<PackageDescription>9 BLISTER PACK in 1 BOX, UNIT-DOSE (63044-153-64) > 10 TABLET, COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>63044-0153-64</NDC11Code>
<ProductNDC>63044-153</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Inatal Advance</ProprietaryName>
<NonProprietaryName>Inatal Advance</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050610</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Nnodum Pharmaceuticals</LabelerName>
<SubstanceName>VITAMIN A; ASCORBIC ACID; CALCIUM CARBONATE; IRON PENTACARBONYL; CHOLECALCIFEROL; ALPHA-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; ZINC OXIDE; CUPRIC OXIDE; MAGNESIUM OXIDE; DOCUSATE SODIUM</SubstanceName>
<StrengthNumber>2700; 120; 200; 90; 400; 30; 3; 3.4; 20; 20; 1; 12; 25; 2; 30; 50</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Vitamin A [CS],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Calcium [CS],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Vitamin D [CS],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC],Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>INATAL ADVANCE ® is a multivitamin/multimineral nutritional supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. INATAL Advanced® can also be beneficial in improving the nutritional status of women prior to conception.</IndicationAndUsage>
<Description>INATAL Advanced ® is a white, dye-free, oval shaped, oil-and-water soluble multivitamin/multimineral tablet which contains calcium carbonate and carbonyl iron. Each tablet contains. Vitamin A (as beta-carotene) . . . . . . . . . . . 2700 I.U. Vitamin C (ascorbic acid) . . . . . . . . . . . . . . 120 mg. Calcium (as calcium carbonate) . . . . . . . . . . 200 mg. Elemental Iron (as carbonyl iron) . . . . . . . . . . 90 mg. Vitamin D3 (cholecalciferol) . . . . . . . . . . . . 400 I.U. Vitamin E (dl-alpha tocopheryl acetate) . . . . . 30 I.U. Vitamin B1 (as thiamine mononitrate) . . . . . . . . 3 mg. Vitamin B2 (riboflavin, USP) . . . . . . . . . . . . . 3.4 mg. Niacinamide . . . . . . . . . . . . . . . . . . . . . . . . 20 mg. Vitamin B6 (as pyridoxine HCI, USP) . . . . . . . 20 mg. Folic Acid, USP . . . . . . . . . . . . . . . . . . . . . . . 1 mg. Vitamin B12 (cyanocobalamin) . . . . . . . . . . . 12 mcg. Zinc (as zinc oxide, USP) . . . . . . . . . . . . . . . . 25 mg. Copper (as cupric oxide) . . . . . . . . . . . . . . . . . 2 mg. Magnesium (as magnesium oxide, USP) . . . . . 30 mg. Docusate Sodium . . . . . . . . . . . . . . . . . . . . 50 mg. INACTIVE INGREDIENTS: Carnauba wax, crospovidone, ethyl vanillin, hydroxypropyl methylcellulose, magnesium stearate, polyethylene glycol, silicon dioxide, stearic acid, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>63044-154-01</NDCCode>
<PackageDescription>100 TABLET, COATED in 1 BOTTLE (63044-154-01)</PackageDescription>
<NDC11Code>63044-0154-01</NDC11Code>
<ProductNDC>63044-154</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Inatal Ultra</ProprietaryName>
<NonProprietaryName>Inatal Ultra</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050620</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Nnodum Pharmaceuticals</LabelerName>
<SubstanceName>VITAMIN A; ASCORBIC ACID; CALCIUM CITRATE; IRON PENTACARBONYL; CHOLECALCIFEROL; ALPHA-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; POTASSIUM IODIDE; ZINC OXIDE; CUPRIC OXIDE; DOCUSATE SODIUM</SubstanceName>
<StrengthNumber>2700; 120; 200; 90; 400; 30; 3; 3.4; 20; 20; 1; 12; 150; 25; 2; 50</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Vitamin A [CS],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Calcium [CS],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Vitamin D [CS],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>INATAL Ultra ® is a multivitamin/multimineral nutritional supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. Ultra NatalCare® can also be beneficial in improving the nutritional status of women prior to conception.</IndicationAndUsage>
<Description>INATAL Ultra is a white, dye free, oval oil-and-water-soluble multivitamin/multimineral tablet with calcium citrate and carbonyl iron. Each tablet contains. Vitamin A* . . . . . . . . . . . . . . . . . . . . . . . 2700 I.U. Vitamin C (Ascorbic Acid) . . . . . . . . . . . . . . 120 mg. Calcium (Calcium Citrate) . . . . . . . . . . . . . 200 mg. Elemental Iron (Carbonyl Iron) . . . . . . . . . . . 90 mg. Vitamin D3 (Cholecalciferol) . . . . . . . . . . . . 400 I.U. Vitamin E (dl-Alpha Tocopheryl Acetate) . . . . . 30 I.U. Vitamin B1 (Thiamine Mononitrate) . . . . . . . . . 3 mg. Vitamin B2 (Riboflavin) . . . . . . . . . . . . . . . . 3.4 mg. Niacinamide . . . . . . . . . . . . . . . . . . . . . . . . 20 mg. Vitamin B6 (Pyridoxine HCI) . . . . . . . . . . . . . 20 mg. Folic Acid . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 mg. Vitamin B12 (Cyanocobalamin) . . . . . . . . . . 12 mcg. Iodine (Potassium Iodide) . . . . . . . . . . . . . 150 mcg. Zinc (Zinc Oxide) . . . . . . . . . . . . . . . . . . . . . 25 mg. Copper (Cupric Oxide) . . . . . . . . . . . . . . . . . 2 mg. Docusate Sodium . . . . . . . . . . . . . . . . . . . . 50 mg. *Input as Vitamin A palmitate and beta carotene.</Description>
</NDC>
<NDC>
<NDCCode>63044-154-63</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 BOX, UNIT-DOSE (63044-154-63) > 10 TABLET, COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>63044-0154-63</NDC11Code>
<ProductNDC>63044-154</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Inatal Ultra</ProprietaryName>
<NonProprietaryName>Inatal Ultra</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050620</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Nnodum Pharmaceuticals</LabelerName>
<SubstanceName>VITAMIN A; ASCORBIC ACID; CALCIUM CITRATE; IRON PENTACARBONYL; CHOLECALCIFEROL; ALPHA-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; POTASSIUM IODIDE; ZINC OXIDE; CUPRIC OXIDE; DOCUSATE SODIUM</SubstanceName>
<StrengthNumber>2700; 120; 200; 90; 400; 30; 3; 3.4; 20; 20; 1; 12; 150; 25; 2; 50</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Vitamin A [CS],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Calcium [CS],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Vitamin D [CS],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>INATAL Ultra ® is a multivitamin/multimineral nutritional supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. Ultra NatalCare® can also be beneficial in improving the nutritional status of women prior to conception.</IndicationAndUsage>
<Description>INATAL Ultra is a white, dye free, oval oil-and-water-soluble multivitamin/multimineral tablet with calcium citrate and carbonyl iron. Each tablet contains. Vitamin A* . . . . . . . . . . . . . . . . . . . . . . . 2700 I.U. Vitamin C (Ascorbic Acid) . . . . . . . . . . . . . . 120 mg. Calcium (Calcium Citrate) . . . . . . . . . . . . . 200 mg. Elemental Iron (Carbonyl Iron) . . . . . . . . . . . 90 mg. Vitamin D3 (Cholecalciferol) . . . . . . . . . . . . 400 I.U. Vitamin E (dl-Alpha Tocopheryl Acetate) . . . . . 30 I.U. Vitamin B1 (Thiamine Mononitrate) . . . . . . . . . 3 mg. Vitamin B2 (Riboflavin) . . . . . . . . . . . . . . . . 3.4 mg. Niacinamide . . . . . . . . . . . . . . . . . . . . . . . . 20 mg. Vitamin B6 (Pyridoxine HCI) . . . . . . . . . . . . . 20 mg. Folic Acid . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 mg. Vitamin B12 (Cyanocobalamin) . . . . . . . . . . 12 mcg. Iodine (Potassium Iodide) . . . . . . . . . . . . . 150 mcg. Zinc (Zinc Oxide) . . . . . . . . . . . . . . . . . . . . . 25 mg. Copper (Cupric Oxide) . . . . . . . . . . . . . . . . . 2 mg. Docusate Sodium . . . . . . . . . . . . . . . . . . . . 50 mg. *Input as Vitamin A palmitate and beta carotene.</Description>
</NDC>
<NDC>
<NDCCode>63044-198-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (63044-198-01)</PackageDescription>
<NDC11Code>63044-0198-01</NDC11Code>
<ProductNDC>63044-198</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Iferex 150 Forte</ProprietaryName>
<NonProprietaryName>Iron, Cyanocobalamin And Folic Acid</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071028</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Nnodum Pharmaceuticals</LabelerName>
<SubstanceName>IRON; CYANOCOBALAMIN; FOLIC ACID</SubstanceName>
<StrengthNumber>150; 25; 1</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-04-26</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63044-203-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (63044-203-01)</PackageDescription>
<NDC11Code>63044-0203-01</NDC11Code>
<ProductNDC>63044-203</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Iferex 150</ProprietaryName>
<NonProprietaryName>Polysaccharide-iron Complex</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071028</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Nnodum Pharmaceuticals</LabelerName>
<SubstanceName>IRON</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-04-20</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63044-203-61</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 BOX, UNIT-DOSE (63044-203-61) > 10 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>63044-0203-61</NDC11Code>
<ProductNDC>63044-203</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Iferex 150</ProprietaryName>
<NonProprietaryName>Polysaccharide-iron Complex</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071028</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Nnodum Pharmaceuticals</LabelerName>
<SubstanceName>IRON</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-04-20</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63044-401-01</NDCCode>
<PackageDescription>30 CAPSULE, GELATIN COATED in 1 BOTTLE (63044-401-01)</PackageDescription>
<NDC11Code>63044-0401-01</NDC11Code>
<ProductNDC>63044-401</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vitamin D3dietary Supplemen</ProprietaryName>
<ProprietaryNameSuffix>Dietary Supplement</ProprietaryNameSuffix>
<NonProprietaryName>Cholecalciferol</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120114</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Nnodum Pharmaceuticals</LabelerName>
<SubstanceName>CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL</SubstanceName>
<StrengthNumber>.25; 5</StrengthNumber>
<StrengthUnit>mg/1; [iU]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63044-404-20</NDCCode>
<PackageDescription>140 g in 1 TUBE (63044-404-20)</PackageDescription>
<NDC11Code>63044-0404-20</NDC11Code>
<ProductNDC>63044-404</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ammonium Lactate</ProprietaryName>
<NonProprietaryName>Ammonium Lactate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20071230</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>Nnodum Pharmaceuticals</LabelerName>
<SubstanceName>AMMONIUM LACTATE</SubstanceName>
<StrengthNumber>17</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ammonium Lactate Cream is indicated for the treatment of dry, scaly skin (xerosis) and ichthyosis vulgaris and for temporary relief of itching associated with these conditions.</IndicationAndUsage>
<Description>Ammonium Lactate Cream, 12% is a formulation of 12% lactic acid neutralized with ammonium hydroxide, as ammonium lactate with a pH of 4.4-5.4. Ingredients: Ammonium Lactate Cream, 12% also contains cetyl alcohol, glycerin, glyceryl stearate, light mineral oil, magnesium aluminum silicate, methyl and propyl parabens, Carbomer 940, PEG-100 stearate, polysorbate 85, triethanolamine, propylene glycol, Petrolatum and Sodium PCA, stearic acid and water. Lactic acid is a racemic mixture of 2-hydroxypropanoic acid and has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>63044-484-09</NDCCode>
<PackageDescription>225 g in 1 BOTTLE, PLASTIC (63044-484-09)</PackageDescription>
<NDC11Code>63044-0484-09</NDC11Code>
<ProductNDC>63044-484</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ammonium Lactate</ProprietaryName>
<NonProprietaryName>Ammonium Lactate</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20071230</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>Nnodum Pharmaceuticals</LabelerName>
<SubstanceName>AMMONIUM LACTATE</SubstanceName>
<StrengthNumber>17</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ammonium Lactate Lotion is indicated for the treatment of dry, scaly skin (xerosis) and ichthyosis vulgaris and for temporary relief of itching associated with these conditions.</IndicationAndUsage>
<Description>Ammonium Lactate Lotion, 12% is a formulation of 12% lactic acid neutralized with ammonium hydroxide, as ammonium lactate with a pH of 4.4-5.4. Ingredients: Ammonium Lactate Lotion, 12% also contains cetyl alcohol, glycerin, glyceryl stearate, light mineral oil, magnesium aluminum silicate, methyl and propyl parabens, Carbomer 940, PEG-100 stearate, polysorbate 85, triethanolamine, propylene glycol, Petrolatum and Sodium PCA, stearic acid and water. Lactic acid is a racemic mixture of 2-hydroxypropanoic acid and has the following structural formula.</Description>
</NDC>
</NDCList>