{
"NDC": [
{
"NDCCode": "50742-657-68",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (50742-657-68) / 28 TABLET in 1 BLISTER PACK",
"NDC11Code": "50742-0657-68",
"ProductNDC": "50742-657",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol And Norethindrone Acetate",
"NonProprietaryName": "Estradiol And Norethindrone Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190403",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210612",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
"SubstanceName": "ESTRADIOL; NORETHINDRONE ACETATE",
"StrengthNumber": "1; .5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190403",
"SamplePackage": "N",
"IndicationAndUsage": "Estradiol and norethindrone acetate tablets are an estrogen and progestin combination indicated in a woman with a uterus for: 1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause (1.1) , 2 Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause (1.2).",
"Description": "Estradiol and norethindrone acetate tablets USP, 1 mg/0.5 mg is a single tablet for oral administration containing 1 mg of estradiol and 0.5 mg of norethindrone acetate and the following excipients: lactose monohydrate, starch (corn), polysorbate 80, copovidone, magnesium stearate, polyvinyl alcohol, titanium dioxide, talc, macrogol/polyethylglycol 3350, lecithin (soya), D&C Yellow NO.10 Aluminum lake, FD&C Blue NO.2 Aluminum lake and FD&C Red NO.40 Aluminum lake. Estradiol and norethindrone acetate tablets USP, 0.5 mg/0.1 mg is a single tablet for oral administration containing 0.5 mg of estradiol and 0.1 mg of norethindrone acetate and the following excipients: lactose monohydrate, starch (corn), polysorbate 80, copovidone, magnesium stearate, polyvinyl alcohol, titanium dioxide, talc, macrogol/polyethylglycol 3350, lecithin (soya), D&C Yellow NO.10 Aluminum lake, FD&C Blue NO.2 Aluminum lake and FD&C Yellow NO.6 Aluminum lake. Estradiol is a white or almost white crystalline powder. Its chemical name is estra-1, 3, 5 (10)- triene-3, 17β-diol hemihydrate with the empirical formula of C18H24O2, ½ H2O and a molecular weight of 281.4. The structural formula of E2 is as follows. Norethindrone acetate (NETA) 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 empirical formula of C22H28O3 and molecular weight of 340.5. The structural formula of NETA is as follows. Product meets USP dissolution test 2."
},
{
"NDCCode": "50742-657-28",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (50742-657-28) / 28 TABLET in 1 BLISTER PACK",
"NDC11Code": "50742-0657-28",
"ProductNDC": "50742-657",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol And Norethindrone Acetate",
"NonProprietaryName": "Estradiol And Norethindrone Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190403",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210612",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
"SubstanceName": "ESTRADIOL; NORETHINDRONE ACETATE",
"StrengthNumber": "1; .5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190403",
"SamplePackage": "N",
"IndicationAndUsage": "Estradiol and norethindrone acetate tablets are an estrogen and progestin combination indicated in a woman with a uterus for: 1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause (1.1) , 2 Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause (1.2).",
"Description": "Estradiol and norethindrone acetate tablets USP, 1 mg/0.5 mg is a single tablet for oral administration containing 1 mg of estradiol and 0.5 mg of norethindrone acetate and the following excipients: lactose monohydrate, starch (corn), polysorbate 80, copovidone, magnesium stearate, polyvinyl alcohol, titanium dioxide, talc, macrogol/polyethylglycol 3350, lecithin (soya), D&C Yellow NO.10 Aluminum lake, FD&C Blue NO.2 Aluminum lake and FD&C Red NO.40 Aluminum lake. Estradiol and norethindrone acetate tablets USP, 0.5 mg/0.1 mg is a single tablet for oral administration containing 0.5 mg of estradiol and 0.1 mg of norethindrone acetate and the following excipients: lactose monohydrate, starch (corn), polysorbate 80, copovidone, magnesium stearate, polyvinyl alcohol, titanium dioxide, talc, macrogol/polyethylglycol 3350, lecithin (soya), D&C Yellow NO.10 Aluminum lake, FD&C Blue NO.2 Aluminum lake and FD&C Yellow NO.6 Aluminum lake. Estradiol is a white or almost white crystalline powder. Its chemical name is estra-1, 3, 5 (10)- triene-3, 17β-diol hemihydrate with the empirical formula of C18H24O2, ½ H2O and a molecular weight of 281.4. The structural formula of E2 is as follows. Norethindrone acetate (NETA) 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 empirical formula of C22H28O3 and molecular weight of 340.5. The structural formula of NETA is as follows. Product meets USP dissolution test 2."
},
{
"NDCCode": "50742-657-84",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (50742-657-84) / 28 TABLET in 1 BLISTER PACK",
"NDC11Code": "50742-0657-84",
"ProductNDC": "50742-657",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol And Norethindrone Acetate",
"NonProprietaryName": "Estradiol And Norethindrone Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190403",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210612",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
"SubstanceName": "ESTRADIOL; NORETHINDRONE ACETATE",
"StrengthNumber": "1; .5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190403",
"SamplePackage": "N",
"IndicationAndUsage": "Estradiol and norethindrone acetate tablets are an estrogen and progestin combination indicated in a woman with a uterus for: 1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause (1.1) , 2 Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause (1.2).",
"Description": "Estradiol and norethindrone acetate tablets USP, 1 mg/0.5 mg is a single tablet for oral administration containing 1 mg of estradiol and 0.5 mg of norethindrone acetate and the following excipients: lactose monohydrate, starch (corn), polysorbate 80, copovidone, magnesium stearate, polyvinyl alcohol, titanium dioxide, talc, macrogol/polyethylglycol 3350, lecithin (soya), D&C Yellow NO.10 Aluminum lake, FD&C Blue NO.2 Aluminum lake and FD&C Red NO.40 Aluminum lake. Estradiol and norethindrone acetate tablets USP, 0.5 mg/0.1 mg is a single tablet for oral administration containing 0.5 mg of estradiol and 0.1 mg of norethindrone acetate and the following excipients: lactose monohydrate, starch (corn), polysorbate 80, copovidone, magnesium stearate, polyvinyl alcohol, titanium dioxide, talc, macrogol/polyethylglycol 3350, lecithin (soya), D&C Yellow NO.10 Aluminum lake, FD&C Blue NO.2 Aluminum lake and FD&C Yellow NO.6 Aluminum lake. Estradiol is a white or almost white crystalline powder. Its chemical name is estra-1, 3, 5 (10)- triene-3, 17β-diol hemihydrate with the empirical formula of C18H24O2, ½ H2O and a molecular weight of 281.4. The structural formula of E2 is as follows. Norethindrone acetate (NETA) 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 empirical formula of C22H28O3 and molecular weight of 340.5. The structural formula of NETA is as follows. Product meets USP dissolution test 2."
},
{
"NDCCode": "50742-658-68",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (50742-658-68) / 28 TABLET in 1 BLISTER PACK",
"NDC11Code": "50742-0658-68",
"ProductNDC": "50742-658",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol And Norethindrone Acetate",
"NonProprietaryName": "Estradiol And Norethindrone Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190403",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210612",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
"SubstanceName": "ESTRADIOL; NORETHINDRONE ACETATE",
"StrengthNumber": ".5; .1",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190403",
"SamplePackage": "N",
"IndicationAndUsage": "Estradiol and norethindrone acetate tablets are an estrogen and progestin combination indicated in a woman with a uterus for: 1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause (1.1) , 2 Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause (1.2).",
"Description": "Estradiol and norethindrone acetate tablets USP, 1 mg/0.5 mg is a single tablet for oral administration containing 1 mg of estradiol and 0.5 mg of norethindrone acetate and the following excipients: lactose monohydrate, starch (corn), polysorbate 80, copovidone, magnesium stearate, polyvinyl alcohol, titanium dioxide, talc, macrogol/polyethylglycol 3350, lecithin (soya), D&C Yellow NO.10 Aluminum lake, FD&C Blue NO.2 Aluminum lake and FD&C Red NO.40 Aluminum lake. Estradiol and norethindrone acetate tablets USP, 0.5 mg/0.1 mg is a single tablet for oral administration containing 0.5 mg of estradiol and 0.1 mg of norethindrone acetate and the following excipients: lactose monohydrate, starch (corn), polysorbate 80, copovidone, magnesium stearate, polyvinyl alcohol, titanium dioxide, talc, macrogol/polyethylglycol 3350, lecithin (soya), D&C Yellow NO.10 Aluminum lake, FD&C Blue NO.2 Aluminum lake and FD&C Yellow NO.6 Aluminum lake. Estradiol is a white or almost white crystalline powder. Its chemical name is estra-1, 3, 5 (10)- triene-3, 17β-diol hemihydrate with the empirical formula of C18H24O2, ½ H2O and a molecular weight of 281.4. The structural formula of E2 is as follows. Norethindrone acetate (NETA) 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 empirical formula of C22H28O3 and molecular weight of 340.5. The structural formula of NETA is as follows. Product meets USP dissolution test 2."
},
{
"NDCCode": "50742-659-68",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (50742-659-68) / 28 TABLET in 1 BLISTER PACK",
"NDC11Code": "50742-0659-68",
"ProductNDC": "50742-659",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dolishale",
"NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091692",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
"SubstanceName": "LEVONORGESTREL; ETHINYL ESTRADIOL",
"StrengthNumber": "90; 20",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Estrogen Receptor Agonists [MoA], Estrogen [EPC], Inhibit Ovum Fertilization [PE], Progesterone Congeners [CS], Progesterone Congeners [CS], Progestin [EPC], Progestin-containing Intrauterine System [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210103",
"SamplePackage": "N",
"IndicationAndUsage": "DOLISHALE is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective for pregnancy prevention. Table 2 lists the typical unintended pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and implants, depend upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Table 2: Percentage of Women Experiencing an Unintended Pregnancy During The First Year of Typical Use and The First Year of Perfect Use of Contraception and The Percentage Continuing Use at The End of the First Year. United States. Emergency Contraceptive Pills: The FDA has concluded that certain combined oral contraceptives containing ethinyl estradiol and norgestrel or levonorgestrel are safe and effective for use as postcoital emergency contraception. Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9. Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraception.10. Source: Trussell J. Contraceptive efficacy. In: Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowel D, Guest F. Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers; 1998. 1. Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 2. Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 3. Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 4. The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5. Foams, creams, gels, vaginal suppositories, and vaginal film. 6. Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7. With spermicidal cream or jelly. 8. Without spermicides. 9. The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following dosage regimens of oral contraceptives to be safe and effective for emergency contraception: for tablets containing 50 mcg of ethinyl estradiol and 500 mcg of norgestrel 1 dose is 2 tablets; for tablets containing 20 mcg of ethinyl estradiol and 100 mcg of levonorgestrel 1 dose is 5 tablets; for tablets containing 30 mcg of ethinyl estradiol and 150 mcg of levonorgestrel 1 dose is 4 tablets. 10. However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age.",
"Description": "Twenty-eight (28) green tablets each containing 90 mcg of levonorgestrel (17α)-(–)13-ethyl-17-hydroxy-18, 19-dinorpregn-4-en-20-yn-3-one, a totally synthetic progestogen, and 20 mcg of ethinyl estradiol, (17α)-19-norpregna-1,3,5(10)-trien-20-yne-3,17-diol. The inactive ingredients present are titanium dioxide, macrogol/PEG 3000 NF, talc, polyvinyl alcohol, lecithin (soya), FD&C Blue #2 Aluminum Lake, FD&C Yellow #5 Aluminum Lake, FD&C Red #40 Aluminum Lake, lactose monohydrate, magnesium stearate and pregelatinized starch."
},
{
"NDCCode": "50742-430-01",
"PackageDescription": "1 VIAL in 1 CARTON (50742-430-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL",
"NDC11Code": "50742-0430-01",
"ProductNDC": "50742-430",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Decitabine",
"NonProprietaryName": "Decitabine",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20190925",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210984",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
"SubstanceName": "DECITABINE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190925",
"SamplePackage": "N",
"IndicationAndUsage": "Decitabine for Injection is indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.",
"Description": "Decitabine is a nucleoside metabolic inhibitor. Decitabine is a fine, white to almost white powder with the molecular formula of C8H12N4O4 and a molecular weight of 228.21. Its chemical name is 4-amino-1-(2-deoxy-β-D-erythro-pentofuranosyl)-1,3,5-triazin-2(1H)-one and it has the following structural formula. Decitabine is slightly soluble in ethanol/water (50/50), methanol/water (50/50) and methanol; sparingly soluble in water and soluble in dimethylsulfoxide (DMSO). Decitabine for Injection, for intravenous use, is a sterile, white to almost white lyophilized powder supplied in a clear colorless glass single-dose vial. Each 20 mL vial contains 50 mg decitabine, 68 mg monobasic potassium phosphate (potassium dihydrogen phosphate) and 11.6 mg sodium hydroxide. Sodium hydroxide and/or hydrochloric acid are used for pH adjustment."
},
{
"NDCCode": "50742-633-10",
"PackageDescription": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-633-10) ",
"NDC11Code": "50742-0633-10",
"ProductNDC": "50742-633",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin",
"NonProprietaryName": "Metformin",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20181210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209674",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2026-04-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181210",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride extended-release tablets are a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1).",
"Description": "Metformin hydrochloride extended-release tablets contain the biguanidine antihyperglycemic agent, metformin, in the form of monohydrochloride salt. The chemical name of metformin HCl is N, N-dimethylimidodicarbonimidic diamide hydrochloride with a molecular formula of C4H11N5HCl and a molecular weight of 165.63. Its structural formula is. Metformin HCl is a white to off-white crystalline powder that is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. Metformin hydrochloride extended-release tablets deliver 500 mg or 1,000 mg of metformin HCl, which is equivalent to 389.93 mg or 779.86 mg metformin, respectively. In addition to the active ingredient metformin HCl, each tablet contains the following inactive ingredients: ethylcellulose, hydroxypropyl cellulose, hypromellose, magnesium stearate, povidone, triethyl citrate, titanium dioxide, polydextrose, triacetin, macrogol/PEG. Product Meets USP Dissolution Test 23."
},
{
"NDCCode": "50742-633-60",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-633-60) ",
"NDC11Code": "50742-0633-60",
"ProductNDC": "50742-633",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin",
"NonProprietaryName": "Metformin",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20181210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209674",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2026-04-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181210",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride extended-release tablets are a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1).",
"Description": "Metformin hydrochloride extended-release tablets contain the biguanidine antihyperglycemic agent, metformin, in the form of monohydrochloride salt. The chemical name of metformin HCl is N, N-dimethylimidodicarbonimidic diamide hydrochloride with a molecular formula of C4H11N5HCl and a molecular weight of 165.63. Its structural formula is. Metformin HCl is a white to off-white crystalline powder that is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. Metformin hydrochloride extended-release tablets deliver 500 mg or 1,000 mg of metformin HCl, which is equivalent to 389.93 mg or 779.86 mg metformin, respectively. In addition to the active ingredient metformin HCl, each tablet contains the following inactive ingredients: ethylcellulose, hydroxypropyl cellulose, hypromellose, magnesium stearate, povidone, triethyl citrate, titanium dioxide, polydextrose, triacetin, macrogol/PEG. Product Meets USP Dissolution Test 23."
},
{
"NDCCode": "50742-633-90",
"PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-633-90) ",
"NDC11Code": "50742-0633-90",
"ProductNDC": "50742-633",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin",
"NonProprietaryName": "Metformin",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20181210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209674",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2026-04-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181210",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride extended-release tablets are a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1).",
"Description": "Metformin hydrochloride extended-release tablets contain the biguanidine antihyperglycemic agent, metformin, in the form of monohydrochloride salt. The chemical name of metformin HCl is N, N-dimethylimidodicarbonimidic diamide hydrochloride with a molecular formula of C4H11N5HCl and a molecular weight of 165.63. Its structural formula is. Metformin HCl is a white to off-white crystalline powder that is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. Metformin hydrochloride extended-release tablets deliver 500 mg or 1,000 mg of metformin HCl, which is equivalent to 389.93 mg or 779.86 mg metformin, respectively. In addition to the active ingredient metformin HCl, each tablet contains the following inactive ingredients: ethylcellulose, hydroxypropyl cellulose, hypromellose, magnesium stearate, povidone, triethyl citrate, titanium dioxide, polydextrose, triacetin, macrogol/PEG. Product Meets USP Dissolution Test 23."
},
{
"NDCCode": "50742-634-10",
"PackageDescription": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-634-10) ",
"NDC11Code": "50742-0634-10",
"ProductNDC": "50742-634",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin",
"NonProprietaryName": "Metformin",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20181210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209674",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2026-04-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181210",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride extended-release tablets are a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1).",
"Description": "Metformin hydrochloride extended-release tablets contain the biguanidine antihyperglycemic agent, metformin, in the form of monohydrochloride salt. The chemical name of metformin HCl is N, N-dimethylimidodicarbonimidic diamide hydrochloride with a molecular formula of C4H11N5HCl and a molecular weight of 165.63. Its structural formula is. Metformin HCl is a white to off-white crystalline powder that is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. Metformin hydrochloride extended-release tablets deliver 500 mg or 1,000 mg of metformin HCl, which is equivalent to 389.93 mg or 779.86 mg metformin, respectively. In addition to the active ingredient metformin HCl, each tablet contains the following inactive ingredients: ethylcellulose, hydroxypropyl cellulose, hypromellose, magnesium stearate, povidone, triethyl citrate, titanium dioxide, polydextrose, triacetin, macrogol/PEG. Product Meets USP Dissolution Test 23."
},
{
"NDCCode": "50742-634-30",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-634-30) ",
"NDC11Code": "50742-0634-30",
"ProductNDC": "50742-634",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin",
"NonProprietaryName": "Metformin",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20181210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209674",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2026-04-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181210",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride extended-release tablets are a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1).",
"Description": "Metformin hydrochloride extended-release tablets contain the biguanidine antihyperglycemic agent, metformin, in the form of monohydrochloride salt. The chemical name of metformin HCl is N, N-dimethylimidodicarbonimidic diamide hydrochloride with a molecular formula of C4H11N5HCl and a molecular weight of 165.63. Its structural formula is. Metformin HCl is a white to off-white crystalline powder that is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. Metformin hydrochloride extended-release tablets deliver 500 mg or 1,000 mg of metformin HCl, which is equivalent to 389.93 mg or 779.86 mg metformin, respectively. In addition to the active ingredient metformin HCl, each tablet contains the following inactive ingredients: ethylcellulose, hydroxypropyl cellulose, hypromellose, magnesium stearate, povidone, triethyl citrate, titanium dioxide, polydextrose, triacetin, macrogol/PEG. Product Meets USP Dissolution Test 23."
},
{
"NDCCode": "50742-634-60",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-634-60) ",
"NDC11Code": "50742-0634-60",
"ProductNDC": "50742-634",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin",
"NonProprietaryName": "Metformin",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20181210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209674",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2026-04-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181210",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride extended-release tablets are a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1).",
"Description": "Metformin hydrochloride extended-release tablets contain the biguanidine antihyperglycemic agent, metformin, in the form of monohydrochloride salt. The chemical name of metformin HCl is N, N-dimethylimidodicarbonimidic diamide hydrochloride with a molecular formula of C4H11N5HCl and a molecular weight of 165.63. Its structural formula is. Metformin HCl is a white to off-white crystalline powder that is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. Metformin hydrochloride extended-release tablets deliver 500 mg or 1,000 mg of metformin HCl, which is equivalent to 389.93 mg or 779.86 mg metformin, respectively. In addition to the active ingredient metformin HCl, each tablet contains the following inactive ingredients: ethylcellulose, hydroxypropyl cellulose, hypromellose, magnesium stearate, povidone, triethyl citrate, titanium dioxide, polydextrose, triacetin, macrogol/PEG. Product Meets USP Dissolution Test 23."
},
{
"NDCCode": "10019-657-06",
"PackageDescription": "6 BOTTLE in 1 CARTON (10019-657-06) / 250 mL in 1 BOTTLE",
"NDC11Code": "10019-0657-06",
"ProductNDC": "10019-657",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sevoflurane",
"NonProprietaryName": "Sevoflurane",
"DosageFormName": "LIQUID",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20020707",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075895",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "SEVOFLURANE",
"StrengthNumber": "250",
"StrengthUnit": "mL/250mL",
"Pharm_Classes": "General Anesthesia [PE], General Anesthetic [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220726",
"SamplePackage": "N",
"IndicationAndUsage": "Sevoflurane is indicated for induction and maintenance of general anesthesia in adult and pediatric patients for inpatient and outpatient surgery. Sevoflurane should be administered only by persons trained in the administration of general anesthesia. Facilities for maintenance of a patent airway, artificial ventilation, oxygen enrichment, and circulatory resuscitation must be immediately available. Since level of anesthesia may be altered rapidly, only vaporizers producing predictable concentrations of sevoflurane should be used.",
"Description": "Sevoflurane, USP, volatile liquid for inhalation, a nonflammable and nonexplosive liquid administered by vaporization, is a halogenated general inhalation anesthetic drug. Sevoflurane, USP is fluoromethyl 2,2,2,-trifluoro-1-(trifluoromethyl) ethyl ether and its structural formula is. Sevoflurane, USP is nonflammable and nonexplosive as defined by the requirements of International Electrotechnical Commission 601-2-13. Sevoflurane, USP is a clear, colorless, liquid containing no additives. Sevoflurane, USP is not corrosive to stainless steel, brass, aluminum, nickel-plated brass, chrome-plated brass or copper beryllium. Sevoflurane, USP is nonpungent. It is miscible with ethanol, ether, chloroform, and benzene, and it is slightly soluble in water. Sevoflurane, USP is stable when stored under normal room lighting conditions according to instructions. No discernible degradation of sevoflurane, USP occurs in the presence of strong acids or heat. When in contact with alkaline CO2 absorbents (e.g., Baralyme® and to a lesser extent soda lime) within the anesthesia machine, Sevoflurane, USP can undergo degradation under certain conditions. Degradation of sevoflurane, USP is minimal, and degradants are either undetectable or present in non-toxic amounts when used as directed with fresh absorbents. Sevoflurane, USP degradation and subsequent degradant formation are enhanced by increasing absorbent temperature increased sevoflurane, USP concentration, decreased fresh gas flow and desiccated CO2 absorbents (especially with potassium hydroxide containing absorbents e.g., Baralyme). Sevoflurane, USP alkaline degradation occurs by two pathways. The first results from the loss of hydrogen fluoride with the formation of pentafluoroisopropenyl fluoromethyl ether, (PIFE, C4H2F6O), also known as Compound A, and trace amounts of pentafluoromethoxy isopropyl fluoromethyl ether, (PMFE, C5H6F6O), also known as Compound B. The second pathway for degradation of sevoflurane, USP, which occurs primarily in the presence of desiccated CO2 absorbents, is discussed later. In the first pathway, the defluorination pathway, the production of degradants in the anesthesia circuit results from the extraction of the acidic proton in the presence of a strong base (KOH and/or NaOH) forming an alkene (Compound A) from sevoflurane, USP similar to formation of 2-bromo-2-chloro-1,1-difluoro ethylene (BCDFE) from halothane. Laboratory simulations have shown that the concentration of these degradants is inversely correlated with the fresh gas flow rate (See Figure 1). Since the reaction of carbon dioxide with absorbents is exothermic, the temperature increase will be determined by quantities of CO2 absorbed, which in turn will depend on fresh gas flow in the anesthesia circle system, metabolic status of the patient, and ventilation. The relationship of temperature produced by varying levels of CO2 and Compound A production is illustrated in the following in vitro simulation where CO2 was added to a circle absorber system. Compound A concentration in a circle absorber system increases as a function of increasing CO2 absorbent temperature and composition (Baralyme producing higher levels than soda lime), increased body temperature, and increased minute ventilation, and decreasing fresh gas flow rates. It has been reported that the concentration of Compound A increases significantly with prolonged dehydration of Baralyme. Compound A exposure in patients also has been shown to rise with increased sevoflurane, USP concentrations and duration of anesthesia. In a clinical study in which sevoflurane, USP was administered to patients under low flow conditions for ≥ 2 hours at flow rates of 1 Liter/minute, Compound A levels were measured in an effort to determine the relationship between MAC hours and Compound A levels produced. The relationship between Compound A levels and sevoflurane, USP exposure are shown in Figure 2a. Compound A has been shown to be nephrotoxic in rats after exposures that have varied in duration from one to three hours. No histopathologic change was seen at a concentration of up to 270 ppm for one hour. Sporadic single cell necrosis of proximal tubule cells has been reported at a concentration of 114 ppm after a 3-hour exposure to Compound A in rats. The LC50 reported at 1 hour is 1050-1090 ppm (male-female) and, at 3 hours, 350-490 ppm (male-female). An experiment was performed comparing sevoflurane, USP plus 75 or 100 ppm Compound A with an active control to evaluate the potential nephrotoxicity of Compound A in non-human primates. A single 8-hour exposure of Sevoflurane, USP in the presence of Compound A produced single-cell renal tubular degeneration and single-cell necrosis in cynomolgus monkeys. These changes are consistent with the increased urinary protein, glucose level and enzymic activity noted on days one and three on the clinical pathology evaluation. This nephrotoxicity produced by Compound A is dose and duration of exposure dependent. At a fresh gas flow rate of 1 L/min, mean maximum concentrations of Compound A in the anesthesia circuit in clinical settings are approximately 20 ppm (0.002%) with soda lime and 30 ppm (0.003%) with Baralyme in adult patients; mean maximum concentrations in pediatric patients with soda lime are about half those found in adults. The highest concentration observed in a single patient with Baralyme was 61 ppm (0.0061%) and 32 ppm (0.0032%) with soda lime. The levels of Compound A at which toxicity occurs in humans is not known. The second pathway for degradation of sevoflurane, USP occurs primarily in the presence of desiccated CO2 absorbents and leads to the dissociation of sevoflurane, USP into hexafluoroisopropanol (HFIP) and formaldehyde. HFIP is inactive, non-genotoxic, rapidly glucuronidated and cleared by the liver. Formaldehyde is present during normal metabolic processes. Upon exposure to a highly desiccated absorbent, formaldehyde can further degrade into methanol and formate. Formate can contribute to the formation of carbon monoxide in the presence of high temperature that can be associated with desiccated Baralyme®. Methanol can react with Compound A to form the methoxy addition product Compound B. Compound B can undergo further HF elimination to form Compounds C, D, and E. Sevoflurane, USP degradants were observed in the respiratory circuit of an experimental anesthesia machine using desiccated CO2 absorbents and maximum sevoflurane, USP concentrations (8%) for extended periods of time (> 2 hours). Concentrations of formaldehyde observed with desiccated soda lime in this experimental anesthesia respiratory circuit were consistent with levels that could potentially result in respiratory irritation. Although KOH containing CO2 absorbents are no longer commercially available, in the laboratory experiments, exposure of sevoflurane, USP to the desiccated KOH containing CO2 absorbent, Baralyme, resulted in the detection of substantially greater degradant levels."
},
{
"NDCCode": "10096-0265-2",
"PackageDescription": "1 TUBE in 1 CARTON (10096-0265-2) > 30 mL in 1 TUBE (10096-0265-1)",
"NDC11Code": "10096-0265-02",
"ProductNDC": "10096-0265",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Magix",
"ProprietaryNameSuffix": "Illuminating Face Perfector",
"NonProprietaryName": "Octisalate, Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20111220",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Avon Products, Inc.",
"SubstanceName": "OCTISALATE; TITANIUM DIOXIDE",
"StrengthNumber": ".9; .657",
"StrengthUnit": "mL/30mL; mL/30mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Uses helps prevent sunburn."
},
{
"NDCCode": "10135-657-60",
"PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10135-657-60) ",
"NDC11Code": "10135-0657-60",
"ProductNDC": "10135-657",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine",
"ProprietaryNameSuffix": "Extended Release",
"NonProprietaryName": "Quetiapine",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209635",
"LabelerName": "Marlex Pharmaceuticals Inc",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20180501",
"SamplePackage": "N",
"IndicationAndUsage": "Quetiapine extended-release tablets are an atypical antipsychotic indicate d for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder, manic or mixed episode s (1.2), 3 Bipolar disorder, depressive episode s (1.2), 4 Major depressive disorder, adjunctive therapy with antidepressants (1.3).",
"Description": "Quetiapine extended-release tablets are 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 C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate, USP is a white to off-white crystalline powder which is soluble in 0.1N hydrochloric acid, slightly soluble in water, in alcohol, and in methanol. Quetiapine extended-release tablets,USP are supplied for oral administration as 150 mg (white), 200 mg (yellow), 300 mg (pale yellow), and 400 mg (white). All tablets are capsule shaped and film coated. Inactive ingredients for quetiapine extended-release tablets are lactose monohydrate, microcrystalline cellulose, sodium citrate dihydrate, hypromellose, and magnesium stearate. The film coating for all quetiapine extended-release tablets, USP contain hypromellose, polyethylene glycol 400 and titanium dioxide. In addition, yellow iron oxide (200 mg and 300 mg tablets) are included in the film coating of specific strengths. Each 150 mg tablet contains 172.7 mg of quetiapine fumarate equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.38 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.5 mg of quetiapine fumarate equivalent to 400 mg quetiapine."
},
{
"NDCCode": "10237-657-60",
"PackageDescription": "1 TUBE in 1 CARTON (10237-657-60) > 170 g in 1 TUBE",
"NDC11Code": "10237-0657-60",
"ProductNDC": "10237-657",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Advance White",
"ProprietaryNameSuffix": "Breath Freshening Tartar Control",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "GEL, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20120129",
"EndMarketingDate": "20221111",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part355",
"LabelerName": "Church & Dwight Co., Inc.",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": "2.4",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2022-11-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20120129",
"EndMarketingDatePackage": "20221111",
"SamplePackage": "N"
},
{
"NDCCode": "10967-657-27",
"PackageDescription": "76 mL in 1 CANISTER (10967-657-27) ",
"NDC11Code": "10967-0657-27",
"ProductNDC": "10967-657",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mitchum Invisible Solid",
"NonProprietaryName": "Aluminum Zirconium Tetrachlorohydex Gly 20%",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20181001",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part350",
"LabelerName": "Revlon Consumer Products Corp.",
"SubstanceName": "ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY",
"StrengthNumber": ".2",
"StrengthUnit": "g/mL",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20181001",
"SamplePackage": "N",
"IndicationAndUsage": "Antiperspirant."
},
{
"NDCCode": "11673-657-02",
"PackageDescription": "11 BLISTER PACK in 1 CARTON (11673-657-02) > 10 GUM, CHEWING in 1 BLISTER PACK",
"NDC11Code": "11673-0657-02",
"ProductNDC": "11673-657",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nicotine Polacrilex",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "GUM, CHEWING",
"RouteName": "ORAL",
"StartMarketingDate": "20100215",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018612",
"LabelerName": "Target Corporation",
"SubstanceName": "NICOTINE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-09-05",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "11673-657-03",
"PackageDescription": "17 BLISTER PACK in 1 CARTON (11673-657-03) > 10 GUM, CHEWING in 1 BLISTER PACK",
"NDC11Code": "11673-0657-03",
"ProductNDC": "11673-657",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nicotine Polacrilex",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "GUM, CHEWING",
"RouteName": "ORAL",
"StartMarketingDate": "20100215",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018612",
"LabelerName": "Target Corporation",
"SubstanceName": "NICOTINE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-09-05",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "11673-657-04",
"PackageDescription": "22 BLISTER PACK in 1 CARTON (11673-657-04) > 10 GUM, CHEWING in 1 BLISTER PACK",
"NDC11Code": "11673-0657-04",
"ProductNDC": "11673-657",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nicotine Polacrilex",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "GUM, CHEWING",
"RouteName": "ORAL",
"StartMarketingDate": "20100215",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018612",
"LabelerName": "Target Corporation",
"SubstanceName": "NICOTINE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-09-05",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "13537-657-12",
"PackageDescription": "1 TUBE in 1 BOX (13537-657-12) > 3.8 g in 1 TUBE (13537-657-11)",
"NDC11Code": "13537-0657-12",
"ProductNDC": "13537-657",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Esika Pro Multi-gloss Dual With Triple Gloss Effect Spf 15",
"ProprietaryNameSuffix": "(fresa) - Red",
"NonProprietaryName": "Octinoxate",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150326",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD",
"SubstanceName": "OCTINOXATE",
"StrengthNumber": ".07",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn. ."
},
{
"NDCCode": "13811-657-10",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (13811-657-10)",
"NDC11Code": "13811-0657-10",
"ProductNDC": "13811-657",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040846",
"LabelerName": "Trigen Laboratories, LLC",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "2.5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2017-11-22"
},
{
"NDCCode": "16571-657-10",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (16571-657-10) ",
"NDC11Code": "16571-0657-10",
"ProductNDC": "16571-657",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cevimeline Hydrochloride",
"NonProprietaryName": "Cevimeline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20140617",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203775",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "CEVIMELINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Agonists [MoA], Cholinergic Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140617",
"SamplePackage": "N",
"IndicationAndUsage": "Cevimeline is indicated for the treatment of symptoms of dry mouth in patients with Sjögren’s Syndrome.",
"Description": "Cevimeline is cis-2’-methylspiro {1-azabicyclo [2.2.2] octane-3, 5’ -[1,3] oxathiolane} hydrochloride, hydrate (2:1). Its empirical formula is C10H17NOS.HCl.1/2 H2O, and its structural formula is. Cevimeline has a molecular weight of 244.79. It is a white to off white crystalline powder with a melting point range of 201 to 203°C. It is freely soluble in alcohol and chloroform, very soluble in water, and virtually insoluble in ether. The pH of a 1% solution ranges from 4.6 to 5.6. Inactive ingredients include lactose monohydrate, hydroxypropyl cellulose, and magnesium stearate. Empty capsule shell consists of Titanium Dioxide and Gelatin. Ink used in the imprint is Black SW-9049 which contains Shellac, Dehydrated alcohol, Isopropyl Alcohol, Butyl Alcohol, Propylene Glycol, Purified Water, Strong Ammonia Solution, Potassium Hydroxide, and Black Iron Oxide."
},
{
"NDCCode": "16714-657-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (16714-657-01) ",
"NDC11Code": "16714-0657-01",
"ProductNDC": "16714-657",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine",
"NonProprietaryName": "Venlafaxine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170126",
"EndMarketingDate": "20240930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078627",
"LabelerName": "Northstar Rx LLC",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170126",
"EndMarketingDatePackage": "20240930",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine tablets, USP is indicated for the treatment of major depressive disorder. The efficacy of venlafaxine tablets, USP in the treatment of major depressive disorder was established in 6 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4 week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets, USP in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets, USP/venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.",
"Description": "Venlafaxine tablets, USP is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethylamino)methyl]-p-methoxybenzyl]cyclohexanol hydrochloride and has the empirical formula of C 17H 27NO 2HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Compressed tablets contain venlafaxine hydrochloride, USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg of venlafaxine base and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, sodium starch glycolate, iron oxide red, iron oxide yellow, colloidal silicon dioxide, and magnesium stearate."
},
{
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"PackageDescription": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (21695-657-60)",
"NDC11Code": "21695-0657-60",
"ProductNDC": "21695-657",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cymbalta",
"NonProprietaryName": "Duloxetine Hydrochloride",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20040824",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021427",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Cymbalta® is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: : 1 Major Depressive Disorder (MDD). (1.1)Efficacy was established in four short-term and one maintenance trial in adults. (14.1) , 2 Generalized Anxiety Disorder (GAD). (1.2)Efficacy was established in three short-term and one maintenance trial in adults. (14.2) , 3 Diabetic Peripheral Neuropathic Pain (DPNP). (1.3) , 4 Fibromyalgia (FM). (1.4) , 5 Chronic Musculoskeletal Pain. (1.5) .",
"Description": "Cymbalta® (duloxetine hydrochloride) is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is:. Duloxetine hydrochloride is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride equivalent to 20, 30, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include FD&C Blue No. 2, gelatin, hypromellose, hydroxypropyl methylcellulose acetate succinate, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, and triethyl citrate. The 20 and 60 mg capsules also contain iron oxide yellow."
},
{
"NDCCode": "24208-657-15",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (24208-657-15) > 15 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "24208-0657-15",
"ProductNDC": "24208-657",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Soothe",
"NonProprietaryName": "Glycerin And Propylene Glycol",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20101027",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part349",
"LabelerName": "Bausch & Lomb Incorporated",
"SubstanceName": "GLYCERIN; PROPYLENE GLYCOL",
"StrengthNumber": ".55; .55",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2015-01-23"
},
{
"NDCCode": "24236-657-35",
"PackageDescription": "30 TABLET in 1 CANISTER (24236-657-35)",
"NDC11Code": "24236-0657-35",
"ProductNDC": "24236-657",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zyprexa",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130410",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020592",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "25021-657-10",
"PackageDescription": "10 VIAL in 1 CARTON (25021-657-10) > 10 mL in 1 VIAL",
"NDC11Code": "25021-0657-10",
"ProductNDC": "25021-657",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vecuronium",
"NonProprietaryName": "Vecuronium Bromide",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20110801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078274",
"LabelerName": "Sagent Pharmaceuticals",
"SubstanceName": "VECURONIUM BROMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "30142-657-72",
"PackageDescription": "1 BOTTLE in 1 CARTON (30142-657-72) / 60 CAPSULE, LIQUID FILLED in 1 BOTTLE",
"NDC11Code": "30142-0657-72",
"ProductNDC": "30142-657",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Gas Relief",
"NonProprietaryName": "Simethicone",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20030124",
"EndMarketingDate": "20260131",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M002",
"LabelerName": "Kroger Company",
"SubstanceName": "DIMETHICONE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Skin Barrier Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20030124",
"EndMarketingDatePackage": "20260131",
"SamplePackage": "N",
"IndicationAndUsage": "relieves bloating, pressure or fullness commonly referred to as gas."
},
{
"NDCCode": "31722-657-31",
"PackageDescription": "1 BOTTLE in 1 CARTON (31722-657-31) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE",
"NDC11Code": "31722-0657-31",
"ProductNDC": "31722-657",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dimethyl Fumarate",
"NonProprietaryName": "Dimethyl Fumarate",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200924",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210500",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "DIMETHYL FUMARATE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2024-05-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200924",
"SamplePackage": "N",
"IndicationAndUsage": "Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.",
"Description": "Dimethyl fumarate delayed-release capsules contain dimethyl fumarate which is also known by its chemical name, dimethyl (E) butenedioate, (C 6H 8O 4). It has the following structure:. Dimethyl fumarate is a white to off white powder that is slightly soluble in dimethylformamide with a molecular mass of 144.13. Dimethyl fumarate is provided as hard gelatin delayed-release capsules for oral administration, containing 120 mg or 240 mg of dimethyl fumarate consisting of the following inactive ingredients: calcium silicate, colloidal silicon dioxide, croscarmellose sodium, gelatin, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, methacrylic acid and methyl methacrylate copolymer, poloxamer, polysorbate 80, silicified microcrystalline cellulose, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide and triethyl citrate. In addition, the 120 mg capsules also contain FD&C Blue 1, iron oxide black and iron oxide yellow. The imprinting ink contains the following inactive ingredients: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
}
]
}
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estradiol And Norethindrone Acetate</ProprietaryName>
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<StartMarketingDate>20190403</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
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<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Estradiol and norethindrone acetate tablets are an estrogen and progestin combination indicated in a woman with a uterus for: 1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause (1.1) , 2 Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause (1.2).</IndicationAndUsage>
<Description>Estradiol and norethindrone acetate tablets USP, 1 mg/0.5 mg is a single tablet for oral administration containing 1 mg of estradiol and 0.5 mg of norethindrone acetate and the following excipients: lactose monohydrate, starch (corn), polysorbate 80, copovidone, magnesium stearate, polyvinyl alcohol, titanium dioxide, talc, macrogol/polyethylglycol 3350, lecithin (soya), D&C Yellow NO.10 Aluminum lake, FD&C Blue NO.2 Aluminum lake and FD&C Red NO.40 Aluminum lake. Estradiol and norethindrone acetate tablets USP, 0.5 mg/0.1 mg is a single tablet for oral administration containing 0.5 mg of estradiol and 0.1 mg of norethindrone acetate and the following excipients: lactose monohydrate, starch (corn), polysorbate 80, copovidone, magnesium stearate, polyvinyl alcohol, titanium dioxide, talc, macrogol/polyethylglycol 3350, lecithin (soya), D&C Yellow NO.10 Aluminum lake, FD&C Blue NO.2 Aluminum lake and FD&C Yellow NO.6 Aluminum lake. Estradiol is a white or almost white crystalline powder. Its chemical name is estra-1, 3, 5 (10)- triene-3, 17β-diol hemihydrate with the empirical formula of C18H24O2, ½ H2O and a molecular weight of 281.4. The structural formula of E2 is as follows. Norethindrone acetate (NETA) 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 empirical formula of C22H28O3 and molecular weight of 340.5. The structural formula of NETA is as follows. Product meets USP dissolution test 2.</Description>
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<NDC>
<NDCCode>50742-657-28</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (50742-657-28) / 28 TABLET in 1 BLISTER PACK</PackageDescription>
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<ProductNDC>50742-657</ProductNDC>
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<Status>Active</Status>
<LastUpdate>2026-06-02</LastUpdate>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190403</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Estradiol and norethindrone acetate tablets are an estrogen and progestin combination indicated in a woman with a uterus for: 1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause (1.1) , 2 Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause (1.2).</IndicationAndUsage>
<Description>Estradiol and norethindrone acetate tablets USP, 1 mg/0.5 mg is a single tablet for oral administration containing 1 mg of estradiol and 0.5 mg of norethindrone acetate and the following excipients: lactose monohydrate, starch (corn), polysorbate 80, copovidone, magnesium stearate, polyvinyl alcohol, titanium dioxide, talc, macrogol/polyethylglycol 3350, lecithin (soya), D&C Yellow NO.10 Aluminum lake, FD&C Blue NO.2 Aluminum lake and FD&C Red NO.40 Aluminum lake. Estradiol and norethindrone acetate tablets USP, 0.5 mg/0.1 mg is a single tablet for oral administration containing 0.5 mg of estradiol and 0.1 mg of norethindrone acetate and the following excipients: lactose monohydrate, starch (corn), polysorbate 80, copovidone, magnesium stearate, polyvinyl alcohol, titanium dioxide, talc, macrogol/polyethylglycol 3350, lecithin (soya), D&C Yellow NO.10 Aluminum lake, FD&C Blue NO.2 Aluminum lake and FD&C Yellow NO.6 Aluminum lake. Estradiol is a white or almost white crystalline powder. Its chemical name is estra-1, 3, 5 (10)- triene-3, 17β-diol hemihydrate with the empirical formula of C18H24O2, ½ H2O and a molecular weight of 281.4. The structural formula of E2 is as follows. Norethindrone acetate (NETA) 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 empirical formula of C22H28O3 and molecular weight of 340.5. The structural formula of NETA is as follows. Product meets USP dissolution test 2.</Description>
</NDC>
<NDC>
<NDCCode>50742-657-84</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (50742-657-84) / 28 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>50742-0657-84</NDC11Code>
<ProductNDC>50742-657</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estradiol And Norethindrone Acetate</ProprietaryName>
<NonProprietaryName>Estradiol And Norethindrone Acetate</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20190403</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210612</ApplicationNumber>
<LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
<SubstanceName>ESTRADIOL; NORETHINDRONE ACETATE</SubstanceName>
<StrengthNumber>1; .5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190403</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Estradiol and norethindrone acetate tablets are an estrogen and progestin combination indicated in a woman with a uterus for: 1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause (1.1) , 2 Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause (1.2).</IndicationAndUsage>
<Description>Estradiol and norethindrone acetate tablets USP, 1 mg/0.5 mg is a single tablet for oral administration containing 1 mg of estradiol and 0.5 mg of norethindrone acetate and the following excipients: lactose monohydrate, starch (corn), polysorbate 80, copovidone, magnesium stearate, polyvinyl alcohol, titanium dioxide, talc, macrogol/polyethylglycol 3350, lecithin (soya), D&C Yellow NO.10 Aluminum lake, FD&C Blue NO.2 Aluminum lake and FD&C Red NO.40 Aluminum lake. Estradiol and norethindrone acetate tablets USP, 0.5 mg/0.1 mg is a single tablet for oral administration containing 0.5 mg of estradiol and 0.1 mg of norethindrone acetate and the following excipients: lactose monohydrate, starch (corn), polysorbate 80, copovidone, magnesium stearate, polyvinyl alcohol, titanium dioxide, talc, macrogol/polyethylglycol 3350, lecithin (soya), D&C Yellow NO.10 Aluminum lake, FD&C Blue NO.2 Aluminum lake and FD&C Yellow NO.6 Aluminum lake. Estradiol is a white or almost white crystalline powder. Its chemical name is estra-1, 3, 5 (10)- triene-3, 17β-diol hemihydrate with the empirical formula of C18H24O2, ½ H2O and a molecular weight of 281.4. The structural formula of E2 is as follows. Norethindrone acetate (NETA) 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 empirical formula of C22H28O3 and molecular weight of 340.5. The structural formula of NETA is as follows. Product meets USP dissolution test 2.</Description>
</NDC>
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<NDCCode>50742-658-68</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 CARTON (50742-658-68) / 28 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>50742-0658-68</NDC11Code>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estradiol And Norethindrone Acetate</ProprietaryName>
<NonProprietaryName>Estradiol And Norethindrone Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190403</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210612</ApplicationNumber>
<LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
<SubstanceName>ESTRADIOL; NORETHINDRONE ACETATE</SubstanceName>
<StrengthNumber>.5; .1</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190403</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Estradiol and norethindrone acetate tablets are an estrogen and progestin combination indicated in a woman with a uterus for: 1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause (1.1) , 2 Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause (1.2).</IndicationAndUsage>
<Description>Estradiol and norethindrone acetate tablets USP, 1 mg/0.5 mg is a single tablet for oral administration containing 1 mg of estradiol and 0.5 mg of norethindrone acetate and the following excipients: lactose monohydrate, starch (corn), polysorbate 80, copovidone, magnesium stearate, polyvinyl alcohol, titanium dioxide, talc, macrogol/polyethylglycol 3350, lecithin (soya), D&C Yellow NO.10 Aluminum lake, FD&C Blue NO.2 Aluminum lake and FD&C Red NO.40 Aluminum lake. Estradiol and norethindrone acetate tablets USP, 0.5 mg/0.1 mg is a single tablet for oral administration containing 0.5 mg of estradiol and 0.1 mg of norethindrone acetate and the following excipients: lactose monohydrate, starch (corn), polysorbate 80, copovidone, magnesium stearate, polyvinyl alcohol, titanium dioxide, talc, macrogol/polyethylglycol 3350, lecithin (soya), D&C Yellow NO.10 Aluminum lake, FD&C Blue NO.2 Aluminum lake and FD&C Yellow NO.6 Aluminum lake. Estradiol is a white or almost white crystalline powder. Its chemical name is estra-1, 3, 5 (10)- triene-3, 17β-diol hemihydrate with the empirical formula of C18H24O2, ½ H2O and a molecular weight of 281.4. The structural formula of E2 is as follows. Norethindrone acetate (NETA) 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 empirical formula of C22H28O3 and molecular weight of 340.5. The structural formula of NETA is as follows. Product meets USP dissolution test 2.</Description>
</NDC>
<NDC>
<NDCCode>50742-659-68</NDCCode>
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<NDC11Code>50742-0659-68</NDC11Code>
<ProductNDC>50742-659</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dolishale</ProprietaryName>
<NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091692</ApplicationNumber>
<LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
<SubstanceName>LEVONORGESTREL; ETHINYL ESTRADIOL</SubstanceName>
<StrengthNumber>90; 20</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Estrogen Receptor Agonists [MoA], Estrogen [EPC], Inhibit Ovum Fertilization [PE], Progesterone Congeners [CS], Progesterone Congeners [CS], Progestin [EPC], Progestin-containing Intrauterine System [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210103</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DOLISHALE is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective for pregnancy prevention. Table 2 lists the typical unintended pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and implants, depend upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Table 2: Percentage of Women Experiencing an Unintended Pregnancy During The First Year of Typical Use and The First Year of Perfect Use of Contraception and The Percentage Continuing Use at The End of the First Year. United States. Emergency Contraceptive Pills: The FDA has concluded that certain combined oral contraceptives containing ethinyl estradiol and norgestrel or levonorgestrel are safe and effective for use as postcoital emergency contraception. Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9. Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraception.10. Source: Trussell J. Contraceptive efficacy. In: Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowel D, Guest F. Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers; 1998. 1. Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 2. Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 3. Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 4. The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5. Foams, creams, gels, vaginal suppositories, and vaginal film. 6. Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7. With spermicidal cream or jelly. 8. Without spermicides. 9. The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following dosage regimens of oral contraceptives to be safe and effective for emergency contraception: for tablets containing 50 mcg of ethinyl estradiol and 500 mcg of norgestrel 1 dose is 2 tablets; for tablets containing 20 mcg of ethinyl estradiol and 100 mcg of levonorgestrel 1 dose is 5 tablets; for tablets containing 30 mcg of ethinyl estradiol and 150 mcg of levonorgestrel 1 dose is 4 tablets. 10. However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age.</IndicationAndUsage>
<Description>Twenty-eight (28) green tablets each containing 90 mcg of levonorgestrel (17α)-(–)13-ethyl-17-hydroxy-18, 19-dinorpregn-4-en-20-yn-3-one, a totally synthetic progestogen, and 20 mcg of ethinyl estradiol, (17α)-19-norpregna-1,3,5(10)-trien-20-yne-3,17-diol. The inactive ingredients present are titanium dioxide, macrogol/PEG 3000 NF, talc, polyvinyl alcohol, lecithin (soya), FD&C Blue #2 Aluminum Lake, FD&C Yellow #5 Aluminum Lake, FD&C Red #40 Aluminum Lake, lactose monohydrate, magnesium stearate and pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>50742-430-01</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (50742-430-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL</PackageDescription>
<NDC11Code>50742-0430-01</NDC11Code>
<ProductNDC>50742-430</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Decitabine</ProprietaryName>
<NonProprietaryName>Decitabine</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20190925</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210984</ApplicationNumber>
<LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
<SubstanceName>DECITABINE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-04-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190925</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Decitabine for Injection is indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.</IndicationAndUsage>
<Description>Decitabine is a nucleoside metabolic inhibitor. Decitabine is a fine, white to almost white powder with the molecular formula of C8H12N4O4 and a molecular weight of 228.21. Its chemical name is 4-amino-1-(2-deoxy-β-D-erythro-pentofuranosyl)-1,3,5-triazin-2(1H)-one and it has the following structural formula. Decitabine is slightly soluble in ethanol/water (50/50), methanol/water (50/50) and methanol; sparingly soluble in water and soluble in dimethylsulfoxide (DMSO). Decitabine for Injection, for intravenous use, is a sterile, white to almost white lyophilized powder supplied in a clear colorless glass single-dose vial. Each 20 mL vial contains 50 mg decitabine, 68 mg monobasic potassium phosphate (potassium dihydrogen phosphate) and 11.6 mg sodium hydroxide. Sodium hydroxide and/or hydrochloric acid are used for pH adjustment.</Description>
</NDC>
<NDC>
<NDCCode>50742-633-10</NDCCode>
<PackageDescription>1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-633-10) </PackageDescription>
<NDC11Code>50742-0633-10</NDC11Code>
<ProductNDC>50742-633</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin</ProprietaryName>
<NonProprietaryName>Metformin</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209674</ApplicationNumber>
<LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride extended-release tablets are a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1).</IndicationAndUsage>
<Description>Metformin hydrochloride extended-release tablets contain the biguanidine antihyperglycemic agent, metformin, in the form of monohydrochloride salt. The chemical name of metformin HCl is N, N-dimethylimidodicarbonimidic diamide hydrochloride with a molecular formula of C4H11N5HCl and a molecular weight of 165.63. Its structural formula is. Metformin HCl is a white to off-white crystalline powder that is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. Metformin hydrochloride extended-release tablets deliver 500 mg or 1,000 mg of metformin HCl, which is equivalent to 389.93 mg or 779.86 mg metformin, respectively. In addition to the active ingredient metformin HCl, each tablet contains the following inactive ingredients: ethylcellulose, hydroxypropyl cellulose, hypromellose, magnesium stearate, povidone, triethyl citrate, titanium dioxide, polydextrose, triacetin, macrogol/PEG. Product Meets USP Dissolution Test 23.</Description>
</NDC>
<NDC>
<NDCCode>50742-633-60</NDCCode>
<PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-633-60) </PackageDescription>
<NDC11Code>50742-0633-60</NDC11Code>
<ProductNDC>50742-633</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin</ProprietaryName>
<NonProprietaryName>Metformin</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209674</ApplicationNumber>
<LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride extended-release tablets are a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1).</IndicationAndUsage>
<Description>Metformin hydrochloride extended-release tablets contain the biguanidine antihyperglycemic agent, metformin, in the form of monohydrochloride salt. The chemical name of metformin HCl is N, N-dimethylimidodicarbonimidic diamide hydrochloride with a molecular formula of C4H11N5HCl and a molecular weight of 165.63. Its structural formula is. Metformin HCl is a white to off-white crystalline powder that is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. Metformin hydrochloride extended-release tablets deliver 500 mg or 1,000 mg of metformin HCl, which is equivalent to 389.93 mg or 779.86 mg metformin, respectively. In addition to the active ingredient metformin HCl, each tablet contains the following inactive ingredients: ethylcellulose, hydroxypropyl cellulose, hypromellose, magnesium stearate, povidone, triethyl citrate, titanium dioxide, polydextrose, triacetin, macrogol/PEG. Product Meets USP Dissolution Test 23.</Description>
</NDC>
<NDC>
<NDCCode>50742-633-90</NDCCode>
<PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-633-90) </PackageDescription>
<NDC11Code>50742-0633-90</NDC11Code>
<ProductNDC>50742-633</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin</ProprietaryName>
<NonProprietaryName>Metformin</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209674</ApplicationNumber>
<LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride extended-release tablets are a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1).</IndicationAndUsage>
<Description>Metformin hydrochloride extended-release tablets contain the biguanidine antihyperglycemic agent, metformin, in the form of monohydrochloride salt. The chemical name of metformin HCl is N, N-dimethylimidodicarbonimidic diamide hydrochloride with a molecular formula of C4H11N5HCl and a molecular weight of 165.63. Its structural formula is. Metformin HCl is a white to off-white crystalline powder that is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. Metformin hydrochloride extended-release tablets deliver 500 mg or 1,000 mg of metformin HCl, which is equivalent to 389.93 mg or 779.86 mg metformin, respectively. In addition to the active ingredient metformin HCl, each tablet contains the following inactive ingredients: ethylcellulose, hydroxypropyl cellulose, hypromellose, magnesium stearate, povidone, triethyl citrate, titanium dioxide, polydextrose, triacetin, macrogol/PEG. Product Meets USP Dissolution Test 23.</Description>
</NDC>
<NDC>
<NDCCode>50742-634-10</NDCCode>
<PackageDescription>1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-634-10) </PackageDescription>
<NDC11Code>50742-0634-10</NDC11Code>
<ProductNDC>50742-634</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin</ProprietaryName>
<NonProprietaryName>Metformin</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209674</ApplicationNumber>
<LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride extended-release tablets are a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1).</IndicationAndUsage>
<Description>Metformin hydrochloride extended-release tablets contain the biguanidine antihyperglycemic agent, metformin, in the form of monohydrochloride salt. The chemical name of metformin HCl is N, N-dimethylimidodicarbonimidic diamide hydrochloride with a molecular formula of C4H11N5HCl and a molecular weight of 165.63. Its structural formula is. Metformin HCl is a white to off-white crystalline powder that is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. Metformin hydrochloride extended-release tablets deliver 500 mg or 1,000 mg of metformin HCl, which is equivalent to 389.93 mg or 779.86 mg metformin, respectively. In addition to the active ingredient metformin HCl, each tablet contains the following inactive ingredients: ethylcellulose, hydroxypropyl cellulose, hypromellose, magnesium stearate, povidone, triethyl citrate, titanium dioxide, polydextrose, triacetin, macrogol/PEG. Product Meets USP Dissolution Test 23.</Description>
</NDC>
<NDC>
<NDCCode>50742-634-30</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-634-30) </PackageDescription>
<NDC11Code>50742-0634-30</NDC11Code>
<ProductNDC>50742-634</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin</ProprietaryName>
<NonProprietaryName>Metformin</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209674</ApplicationNumber>
<LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride extended-release tablets are a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1).</IndicationAndUsage>
<Description>Metformin hydrochloride extended-release tablets contain the biguanidine antihyperglycemic agent, metformin, in the form of monohydrochloride salt. The chemical name of metformin HCl is N, N-dimethylimidodicarbonimidic diamide hydrochloride with a molecular formula of C4H11N5HCl and a molecular weight of 165.63. Its structural formula is. Metformin HCl is a white to off-white crystalline powder that is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. Metformin hydrochloride extended-release tablets deliver 500 mg or 1,000 mg of metformin HCl, which is equivalent to 389.93 mg or 779.86 mg metformin, respectively. In addition to the active ingredient metformin HCl, each tablet contains the following inactive ingredients: ethylcellulose, hydroxypropyl cellulose, hypromellose, magnesium stearate, povidone, triethyl citrate, titanium dioxide, polydextrose, triacetin, macrogol/PEG. Product Meets USP Dissolution Test 23.</Description>
</NDC>
<NDC>
<NDCCode>50742-634-60</NDCCode>
<PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-634-60) </PackageDescription>
<NDC11Code>50742-0634-60</NDC11Code>
<ProductNDC>50742-634</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin</ProprietaryName>
<NonProprietaryName>Metformin</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209674</ApplicationNumber>
<LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride extended-release tablets are a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1).</IndicationAndUsage>
<Description>Metformin hydrochloride extended-release tablets contain the biguanidine antihyperglycemic agent, metformin, in the form of monohydrochloride salt. The chemical name of metformin HCl is N, N-dimethylimidodicarbonimidic diamide hydrochloride with a molecular formula of C4H11N5HCl and a molecular weight of 165.63. Its structural formula is. Metformin HCl is a white to off-white crystalline powder that is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. Metformin hydrochloride extended-release tablets deliver 500 mg or 1,000 mg of metformin HCl, which is equivalent to 389.93 mg or 779.86 mg metformin, respectively. In addition to the active ingredient metformin HCl, each tablet contains the following inactive ingredients: ethylcellulose, hydroxypropyl cellulose, hypromellose, magnesium stearate, povidone, triethyl citrate, titanium dioxide, polydextrose, triacetin, macrogol/PEG. Product Meets USP Dissolution Test 23.</Description>
</NDC>
<NDC>
<NDCCode>10019-657-06</NDCCode>
<PackageDescription>6 BOTTLE in 1 CARTON (10019-657-06) / 250 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>10019-0657-06</NDC11Code>
<ProductNDC>10019-657</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sevoflurane</ProprietaryName>
<NonProprietaryName>Sevoflurane</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20020707</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075895</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>SEVOFLURANE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mL/250mL</StrengthUnit>
<Pharm_Classes>General Anesthesia [PE], General Anesthetic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220726</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sevoflurane is indicated for induction and maintenance of general anesthesia in adult and pediatric patients for inpatient and outpatient surgery. Sevoflurane should be administered only by persons trained in the administration of general anesthesia. Facilities for maintenance of a patent airway, artificial ventilation, oxygen enrichment, and circulatory resuscitation must be immediately available. Since level of anesthesia may be altered rapidly, only vaporizers producing predictable concentrations of sevoflurane should be used.</IndicationAndUsage>
<Description>Sevoflurane, USP, volatile liquid for inhalation, a nonflammable and nonexplosive liquid administered by vaporization, is a halogenated general inhalation anesthetic drug. Sevoflurane, USP is fluoromethyl 2,2,2,-trifluoro-1-(trifluoromethyl) ethyl ether and its structural formula is. Sevoflurane, USP is nonflammable and nonexplosive as defined by the requirements of International Electrotechnical Commission 601-2-13. Sevoflurane, USP is a clear, colorless, liquid containing no additives. Sevoflurane, USP is not corrosive to stainless steel, brass, aluminum, nickel-plated brass, chrome-plated brass or copper beryllium. Sevoflurane, USP is nonpungent. It is miscible with ethanol, ether, chloroform, and benzene, and it is slightly soluble in water. Sevoflurane, USP is stable when stored under normal room lighting conditions according to instructions. No discernible degradation of sevoflurane, USP occurs in the presence of strong acids or heat. When in contact with alkaline CO2 absorbents (e.g., Baralyme® and to a lesser extent soda lime) within the anesthesia machine, Sevoflurane, USP can undergo degradation under certain conditions. Degradation of sevoflurane, USP is minimal, and degradants are either undetectable or present in non-toxic amounts when used as directed with fresh absorbents. Sevoflurane, USP degradation and subsequent degradant formation are enhanced by increasing absorbent temperature increased sevoflurane, USP concentration, decreased fresh gas flow and desiccated CO2 absorbents (especially with potassium hydroxide containing absorbents e.g., Baralyme). Sevoflurane, USP alkaline degradation occurs by two pathways. The first results from the loss of hydrogen fluoride with the formation of pentafluoroisopropenyl fluoromethyl ether, (PIFE, C4H2F6O), also known as Compound A, and trace amounts of pentafluoromethoxy isopropyl fluoromethyl ether, (PMFE, C5H6F6O), also known as Compound B. The second pathway for degradation of sevoflurane, USP, which occurs primarily in the presence of desiccated CO2 absorbents, is discussed later. In the first pathway, the defluorination pathway, the production of degradants in the anesthesia circuit results from the extraction of the acidic proton in the presence of a strong base (KOH and/or NaOH) forming an alkene (Compound A) from sevoflurane, USP similar to formation of 2-bromo-2-chloro-1,1-difluoro ethylene (BCDFE) from halothane. Laboratory simulations have shown that the concentration of these degradants is inversely correlated with the fresh gas flow rate (See Figure 1). Since the reaction of carbon dioxide with absorbents is exothermic, the temperature increase will be determined by quantities of CO2 absorbed, which in turn will depend on fresh gas flow in the anesthesia circle system, metabolic status of the patient, and ventilation. The relationship of temperature produced by varying levels of CO2 and Compound A production is illustrated in the following in vitro simulation where CO2 was added to a circle absorber system. Compound A concentration in a circle absorber system increases as a function of increasing CO2 absorbent temperature and composition (Baralyme producing higher levels than soda lime), increased body temperature, and increased minute ventilation, and decreasing fresh gas flow rates. It has been reported that the concentration of Compound A increases significantly with prolonged dehydration of Baralyme. Compound A exposure in patients also has been shown to rise with increased sevoflurane, USP concentrations and duration of anesthesia. In a clinical study in which sevoflurane, USP was administered to patients under low flow conditions for ≥ 2 hours at flow rates of 1 Liter/minute, Compound A levels were measured in an effort to determine the relationship between MAC hours and Compound A levels produced. The relationship between Compound A levels and sevoflurane, USP exposure are shown in Figure 2a. Compound A has been shown to be nephrotoxic in rats after exposures that have varied in duration from one to three hours. No histopathologic change was seen at a concentration of up to 270 ppm for one hour. Sporadic single cell necrosis of proximal tubule cells has been reported at a concentration of 114 ppm after a 3-hour exposure to Compound A in rats. The LC50 reported at 1 hour is 1050-1090 ppm (male-female) and, at 3 hours, 350-490 ppm (male-female). An experiment was performed comparing sevoflurane, USP plus 75 or 100 ppm Compound A with an active control to evaluate the potential nephrotoxicity of Compound A in non-human primates. A single 8-hour exposure of Sevoflurane, USP in the presence of Compound A produced single-cell renal tubular degeneration and single-cell necrosis in cynomolgus monkeys. These changes are consistent with the increased urinary protein, glucose level and enzymic activity noted on days one and three on the clinical pathology evaluation. This nephrotoxicity produced by Compound A is dose and duration of exposure dependent. At a fresh gas flow rate of 1 L/min, mean maximum concentrations of Compound A in the anesthesia circuit in clinical settings are approximately 20 ppm (0.002%) with soda lime and 30 ppm (0.003%) with Baralyme in adult patients; mean maximum concentrations in pediatric patients with soda lime are about half those found in adults. The highest concentration observed in a single patient with Baralyme was 61 ppm (0.0061%) and 32 ppm (0.0032%) with soda lime. The levels of Compound A at which toxicity occurs in humans is not known. The second pathway for degradation of sevoflurane, USP occurs primarily in the presence of desiccated CO2 absorbents and leads to the dissociation of sevoflurane, USP into hexafluoroisopropanol (HFIP) and formaldehyde. HFIP is inactive, non-genotoxic, rapidly glucuronidated and cleared by the liver. Formaldehyde is present during normal metabolic processes. Upon exposure to a highly desiccated absorbent, formaldehyde can further degrade into methanol and formate. Formate can contribute to the formation of carbon monoxide in the presence of high temperature that can be associated with desiccated Baralyme®. Methanol can react with Compound A to form the methoxy addition product Compound B. Compound B can undergo further HF elimination to form Compounds C, D, and E. Sevoflurane, USP degradants were observed in the respiratory circuit of an experimental anesthesia machine using desiccated CO2 absorbents and maximum sevoflurane, USP concentrations (8%) for extended periods of time (> 2 hours). Concentrations of formaldehyde observed with desiccated soda lime in this experimental anesthesia respiratory circuit were consistent with levels that could potentially result in respiratory irritation. Although KOH containing CO2 absorbents are no longer commercially available, in the laboratory experiments, exposure of sevoflurane, USP to the desiccated KOH containing CO2 absorbent, Baralyme, resulted in the detection of substantially greater degradant levels.</Description>
</NDC>
<NDC>
<NDCCode>10096-0265-2</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (10096-0265-2) > 30 mL in 1 TUBE (10096-0265-1)</PackageDescription>
<NDC11Code>10096-0265-02</NDC11Code>
<ProductNDC>10096-0265</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Magix</ProprietaryName>
<ProprietaryNameSuffix>Illuminating Face Perfector</ProprietaryNameSuffix>
<NonProprietaryName>Octisalate, Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20111220</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Avon Products, Inc.</LabelerName>
<SubstanceName>OCTISALATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>.9; .657</StrengthNumber>
<StrengthUnit>mL/30mL; mL/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10135-657-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10135-657-60) </PackageDescription>
<NDC11Code>10135-0657-60</NDC11Code>
<ProductNDC>10135-657</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quetiapine</ProprietaryName>
<ProprietaryNameSuffix>Extended Release</ProprietaryNameSuffix>
<NonProprietaryName>Quetiapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209635</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals Inc</LabelerName>
<SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Quetiapine extended-release tablets are an atypical antipsychotic indicate d for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder, manic or mixed episode s (1.2), 3 Bipolar disorder, depressive episode s (1.2), 4 Major depressive disorder, adjunctive therapy with antidepressants (1.3).</IndicationAndUsage>
<Description>Quetiapine extended-release tablets are 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 C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate, USP is a white to off-white crystalline powder which is soluble in 0.1N hydrochloric acid, slightly soluble in water, in alcohol, and in methanol. Quetiapine extended-release tablets,USP are supplied for oral administration as 150 mg (white), 200 mg (yellow), 300 mg (pale yellow), and 400 mg (white). All tablets are capsule shaped and film coated. Inactive ingredients for quetiapine extended-release tablets are lactose monohydrate, microcrystalline cellulose, sodium citrate dihydrate, hypromellose, and magnesium stearate. The film coating for all quetiapine extended-release tablets, USP contain hypromellose, polyethylene glycol 400 and titanium dioxide. In addition, yellow iron oxide (200 mg and 300 mg tablets) are included in the film coating of specific strengths. Each 150 mg tablet contains 172.7 mg of quetiapine fumarate equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.38 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.5 mg of quetiapine fumarate equivalent to 400 mg quetiapine.</Description>
</NDC>
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<NDCCode>10237-657-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (10237-657-60) > 170 g in 1 TUBE</PackageDescription>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Advance White</ProprietaryName>
<ProprietaryNameSuffix>Breath Freshening Tartar Control</ProprietaryNameSuffix>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>GEL, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20120129</StartMarketingDate>
<EndMarketingDate>20221111</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part355</ApplicationNumber>
<LabelerName>Church & Dwight Co., Inc.</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>2.4</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-11-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20120129</StartMarketingDatePackage>
<EndMarketingDatePackage>20221111</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>10967-657-27</NDCCode>
<PackageDescription>76 mL in 1 CANISTER (10967-657-27) </PackageDescription>
<NDC11Code>10967-0657-27</NDC11Code>
<ProductNDC>10967-657</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mitchum Invisible Solid</ProprietaryName>
<NonProprietaryName>Aluminum Zirconium Tetrachlorohydex Gly 20%</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20181001</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part350</ApplicationNumber>
<LabelerName>Revlon Consumer Products Corp.</LabelerName>
<SubstanceName>ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Antiperspirant.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11673-657-02</NDCCode>
<PackageDescription>11 BLISTER PACK in 1 CARTON (11673-657-02) > 10 GUM, CHEWING in 1 BLISTER PACK</PackageDescription>
<NDC11Code>11673-0657-02</NDC11Code>
<ProductNDC>11673-657</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nicotine Polacrilex</ProprietaryName>
<NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
<DosageFormName>GUM, CHEWING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100215</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018612</ApplicationNumber>
<LabelerName>Target Corporation</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-09-05</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>11673-657-03</NDCCode>
<PackageDescription>17 BLISTER PACK in 1 CARTON (11673-657-03) > 10 GUM, CHEWING in 1 BLISTER PACK</PackageDescription>
<NDC11Code>11673-0657-03</NDC11Code>
<ProductNDC>11673-657</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nicotine Polacrilex</ProprietaryName>
<NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
<DosageFormName>GUM, CHEWING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100215</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018612</ApplicationNumber>
<LabelerName>Target Corporation</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-09-05</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>11673-657-04</NDCCode>
<PackageDescription>22 BLISTER PACK in 1 CARTON (11673-657-04) > 10 GUM, CHEWING in 1 BLISTER PACK</PackageDescription>
<NDC11Code>11673-0657-04</NDC11Code>
<ProductNDC>11673-657</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nicotine Polacrilex</ProprietaryName>
<NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
<DosageFormName>GUM, CHEWING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100215</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018612</ApplicationNumber>
<LabelerName>Target Corporation</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-09-05</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>13537-657-12</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (13537-657-12) > 3.8 g in 1 TUBE (13537-657-11)</PackageDescription>
<NDC11Code>13537-0657-12</NDC11Code>
<ProductNDC>13537-657</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Esika Pro Multi-gloss Dual With Triple Gloss Effect Spf 15</ProprietaryName>
<ProprietaryNameSuffix>(fresa) - Red</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate</NonProprietaryName>
<DosageFormName>LIPSTICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150326</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation LTD</LabelerName>
<SubstanceName>OCTINOXATE</SubstanceName>
<StrengthNumber>.07</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn. .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>13811-657-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (13811-657-10)</PackageDescription>
<NDC11Code>13811-0657-10</NDC11Code>
<ProductNDC>13811-657</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040846</ApplicationNumber>
<LabelerName>Trigen Laboratories, LLC</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>2.5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2017-11-22</LastUpdate>
</NDC>
<NDC>
<NDCCode>16571-657-10</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (16571-657-10) </PackageDescription>
<NDC11Code>16571-0657-10</NDC11Code>
<ProductNDC>16571-657</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cevimeline Hydrochloride</ProprietaryName>
<NonProprietaryName>Cevimeline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140617</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203775</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>CEVIMELINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Agonists [MoA], Cholinergic Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140617</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cevimeline is indicated for the treatment of symptoms of dry mouth in patients with Sjögren’s Syndrome.</IndicationAndUsage>
<Description>Cevimeline is cis-2’-methylspiro {1-azabicyclo [2.2.2] octane-3, 5’ -[1,3] oxathiolane} hydrochloride, hydrate (2:1). Its empirical formula is C10H17NOS.HCl.1/2 H2O, and its structural formula is. Cevimeline has a molecular weight of 244.79. It is a white to off white crystalline powder with a melting point range of 201 to 203°C. It is freely soluble in alcohol and chloroform, very soluble in water, and virtually insoluble in ether. The pH of a 1% solution ranges from 4.6 to 5.6. Inactive ingredients include lactose monohydrate, hydroxypropyl cellulose, and magnesium stearate. Empty capsule shell consists of Titanium Dioxide and Gelatin. Ink used in the imprint is Black SW-9049 which contains Shellac, Dehydrated alcohol, Isopropyl Alcohol, Butyl Alcohol, Propylene Glycol, Purified Water, Strong Ammonia Solution, Potassium Hydroxide, and Black Iron Oxide.</Description>
</NDC>
<NDC>
<NDCCode>16714-657-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (16714-657-01) </PackageDescription>
<NDC11Code>16714-0657-01</NDC11Code>
<ProductNDC>16714-657</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine</ProprietaryName>
<NonProprietaryName>Venlafaxine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170126</StartMarketingDate>
<EndMarketingDate>20240930</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078627</ApplicationNumber>
<LabelerName>Northstar Rx LLC</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170126</StartMarketingDatePackage>
<EndMarketingDatePackage>20240930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine tablets, USP is indicated for the treatment of major depressive disorder. The efficacy of venlafaxine tablets, USP in the treatment of major depressive disorder was established in 6 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4 week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets, USP in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets, USP/venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Venlafaxine tablets, USP is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethylamino)methyl]-p-methoxybenzyl]cyclohexanol hydrochloride and has the empirical formula of C 17H 27NO 2HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Compressed tablets contain venlafaxine hydrochloride, USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg of venlafaxine base and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, sodium starch glycolate, iron oxide red, iron oxide yellow, colloidal silicon dioxide, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>21695-657-60</NDCCode>
<PackageDescription>60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (21695-657-60)</PackageDescription>
<NDC11Code>21695-0657-60</NDC11Code>
<ProductNDC>21695-657</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cymbalta</ProprietaryName>
<NonProprietaryName>Duloxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040824</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021427</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Cymbalta® is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: : 1 Major Depressive Disorder (MDD). (1.1)Efficacy was established in four short-term and one maintenance trial in adults. (14.1) , 2 Generalized Anxiety Disorder (GAD). (1.2)Efficacy was established in three short-term and one maintenance trial in adults. (14.2) , 3 Diabetic Peripheral Neuropathic Pain (DPNP). (1.3) , 4 Fibromyalgia (FM). (1.4) , 5 Chronic Musculoskeletal Pain. (1.5) .</IndicationAndUsage>
<Description>Cymbalta® (duloxetine hydrochloride) is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is:. Duloxetine hydrochloride is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride equivalent to 20, 30, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include FD&C Blue No. 2, gelatin, hypromellose, hydroxypropyl methylcellulose acetate succinate, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, and triethyl citrate. The 20 and 60 mg capsules also contain iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>24208-657-15</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (24208-657-15) > 15 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>24208-0657-15</NDC11Code>
<ProductNDC>24208-657</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Soothe</ProprietaryName>
<NonProprietaryName>Glycerin And Propylene Glycol</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20101027</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part349</ApplicationNumber>
<LabelerName>Bausch & Lomb Incorporated</LabelerName>
<SubstanceName>GLYCERIN; PROPYLENE GLYCOL</SubstanceName>
<StrengthNumber>.55; .55</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-01-23</LastUpdate>
</NDC>
<NDC>
<NDCCode>24236-657-35</NDCCode>
<PackageDescription>30 TABLET in 1 CANISTER (24236-657-35)</PackageDescription>
<NDC11Code>24236-0657-35</NDC11Code>
<ProductNDC>24236-657</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zyprexa</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130410</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020592</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>25021-657-10</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (25021-657-10) > 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>25021-0657-10</NDC11Code>
<ProductNDC>25021-657</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vecuronium</ProprietaryName>
<NonProprietaryName>Vecuronium Bromide</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20110801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078274</ApplicationNumber>
<LabelerName>Sagent Pharmaceuticals</LabelerName>
<SubstanceName>VECURONIUM BROMIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>30142-657-72</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (30142-657-72) / 60 CAPSULE, LIQUID FILLED in 1 BOTTLE</PackageDescription>
<NDC11Code>30142-0657-72</NDC11Code>
<ProductNDC>30142-657</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Gas Relief</ProprietaryName>
<NonProprietaryName>Simethicone</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030124</StartMarketingDate>
<EndMarketingDate>20260131</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M002</ApplicationNumber>
<LabelerName>Kroger Company</LabelerName>
<SubstanceName>DIMETHICONE</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Skin Barrier Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20030124</StartMarketingDatePackage>
<EndMarketingDatePackage>20260131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves bloating, pressure or fullness commonly referred to as gas.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>31722-657-31</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (31722-657-31) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE</PackageDescription>
<NDC11Code>31722-0657-31</NDC11Code>
<ProductNDC>31722-657</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dimethyl Fumarate</ProprietaryName>
<NonProprietaryName>Dimethyl Fumarate</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200924</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210500</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DIMETHYL FUMARATE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-05-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200924</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
<Description>Dimethyl fumarate delayed-release capsules contain dimethyl fumarate which is also known by its chemical name, dimethyl (E) butenedioate, (C 6H 8O 4). It has the following structure:. Dimethyl fumarate is a white to off white powder that is slightly soluble in dimethylformamide with a molecular mass of 144.13. Dimethyl fumarate is provided as hard gelatin delayed-release capsules for oral administration, containing 120 mg or 240 mg of dimethyl fumarate consisting of the following inactive ingredients: calcium silicate, colloidal silicon dioxide, croscarmellose sodium, gelatin, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, methacrylic acid and methyl methacrylate copolymer, poloxamer, polysorbate 80, silicified microcrystalline cellulose, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide and triethyl citrate. In addition, the 120 mg capsules also contain FD&C Blue 1, iron oxide black and iron oxide yellow. The imprinting ink contains the following inactive ingredients: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
</NDCList>