{
"NDC": [
{
"NDCCode": "21922-077-25",
"PackageDescription": "1 TUBE in 1 CARTON (21922-077-25) / 20 g in 1 TUBE",
"NDC11Code": "21922-0077-25",
"ProductNDC": "21922-077",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tretinoin",
"NonProprietaryName": "Tretinoin",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260213",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217833",
"LabelerName": "Encube Ethicals, Inc.",
"SubstanceName": "TRETINOIN",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2026-04-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260213",
"SamplePackage": "N",
"IndicationAndUsage": "Tretinoin cream is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.",
"Description": "Tretinoin Cream, USP are used for the topical treatment of acne vulgaris. Tretinoin Cream, USP contains tretinoin in either of three strengths, 0.1%, 0.05% or 0.025% by weight, in a hydrophilic cream vehicle of stearic acid, isopropyl myristate, polyoxyl 40 stearate, stearyl alcohol, xanthan gum, sorbic acid, butylated hydroxytoluene, and purified water. Chemically, tretinoin is all-trans-retinoic acid and has the following structure."
},
{
"NDCCode": "21922-077-06",
"PackageDescription": "1 TUBE in 1 CARTON (21922-077-06) / 45 g in 1 TUBE",
"NDC11Code": "21922-0077-06",
"ProductNDC": "21922-077",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tretinoin",
"NonProprietaryName": "Tretinoin",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260213",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217833",
"LabelerName": "Encube Ethicals, Inc.",
"SubstanceName": "TRETINOIN",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2026-04-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260213",
"SamplePackage": "N",
"IndicationAndUsage": "Tretinoin cream is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.",
"Description": "Tretinoin Cream, USP are used for the topical treatment of acne vulgaris. Tretinoin Cream, USP contains tretinoin in either of three strengths, 0.1%, 0.05% or 0.025% by weight, in a hydrophilic cream vehicle of stearic acid, isopropyl myristate, polyoxyl 40 stearate, stearyl alcohol, xanthan gum, sorbic acid, butylated hydroxytoluene, and purified water. Chemically, tretinoin is all-trans-retinoic acid and has the following structure."
},
{
"NDCCode": "21922-019-52",
"PackageDescription": "30 PACKET in 1 CARTON (21922-019-52) / 25 g in 1 PACKET",
"NDC11Code": "21922-0019-52",
"ProductNDC": "21922-019",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Testosterone Gel, 1%",
"NonProprietaryName": "Testosterone Gel, 1%",
"DosageFormName": "GEL",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20210110",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212984",
"LabelerName": "Encube Ethicals, Inc.",
"SubstanceName": "TESTOSTERONE",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2025-10-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240812",
"SamplePackage": "N",
"IndicationAndUsage": "Testosterone gel, 1% is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: : 1 Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range. , 2 Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations, but have gonadotropins in the normal or low range. .",
"Description": "Testosterone gel, 1% is a clear, colorless to yellowish hydroalcoholic gel containing testosterone, USP. The active pharmacologic ingredient in testosterone gel 1% is testosterone, USP an androgen. Testosterone, USP is a white to practically white crystalline powder chemically described as 17-beta hydroxyandrost-4-en-3-one. The structural formula is. Pharmacologically inactive ingredients in testosterone gel, 1% are carbomer 980, ethyl alcohol 67.0%, isopropyl myristate, purified water, and sodium hydroxide. These ingredients are not pharmacologically active."
},
{
"NDCCode": "21922-044-25",
"PackageDescription": "1 TUBE in 1 CARTON (21922-044-25) / 20 g in 1 TUBE",
"NDC11Code": "21922-0044-25",
"ProductNDC": "21922-044",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Diclofenac Sodium",
"NonProprietaryName": "Diclofenac Sodium Topical Gel, 1%",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200811",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210986",
"LabelerName": "Encube Ethicals, Inc.",
"SubstanceName": "DICLOFENAC SODIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210201",
"SamplePackage": "N",
"IndicationAndUsage": "for the temporary relief of arthritis pain ONLY in the following areas: hand, wrist, elbow (upper body areas)foot, ankle, knee (lower body areas). this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use."
},
{
"NDCCode": "21922-061-22",
"PackageDescription": "1 BOTTLE in 1 CARTON (21922-061-22) / 25 mL in 1 BOTTLE",
"NDC11Code": "21922-0061-22",
"ProductNDC": "21922-061",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240610",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076977",
"LabelerName": "Encube Ethicals, Inc.",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240610",
"SamplePackage": "N",
"IndicationAndUsage": "Clobetasol Propionate Topical Solution, 0.05% is indicated for short-term topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 mL/week because of the potential for the drug to suppress the HPA axis. This product is not recommended for use in pediatric patients under 12 years of age.",
"Description": "Clobetasol Propionate Topical Solution USP, 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is (11β,16β)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)pregna-1,4-diene-3,20-dione, and it has the following structural formula. Clobetasol propionate has the molecular formula C25H32ClFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol Propionate Topical Solution USP, 0.05% contains clobetasol propionate 0.5 mg/g in a base of carbopol 974P, isopropyl alcohol (39.3%), purified water and sodium hydroxide."
},
{
"NDCCode": "21922-073-25",
"PackageDescription": "1 TUBE in 1 CARTON (21922-073-25) / 22 g in 1 TUBE",
"NDC11Code": "21922-0073-25",
"ProductNDC": "21922-073",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mupirocin",
"NonProprietaryName": "Mupirocin",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250516",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217943",
"LabelerName": "Encube Ethicals, Inc.",
"SubstanceName": "MUPIROCIN",
"StrengthNumber": "20",
"StrengthUnit": "mg/g",
"Pharm_Classes": "RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250516",
"SamplePackage": "N",
"IndicationAndUsage": "Mupirocin Ointment USP, 2% is indicated for the topical treatment of impetigo due to susceptible isolates of Staphylococcus aureus(S. aureus)and Streptococcus pyogenes(S. pyogenes).",
"Description": "Mupirocin Ointment USP, 2% contains the RNA synthetase inhibitor antibacterial, mupirocin, USP. The chemical name is (E)- (2S,3R,4R,5S)-5-[ (2S,3S,4S,5S)-2,3-epoxy-5-hydroxy-4-methylhexyl] tetrahydro-3,4-dihydroxy-β-methyl-2 H-pyran-2-crotonic acid, ester with 9-hydroxynonanoic acid. The molecular formula of mupirocin, USP is C 26H 44O 9, and the molecular weight is 500.6. The structural formula of mupirocin, USP is:. Figure 1. Structure of Mupirocin, USP. Each gram of Mupirocin Ointment USP, 2% contains 20 mg mupirocin, USP in a water-miscible ointment base (polyethylene glycol ointment, NF) consisting of polyethylene glycol 400 and polyethylene glycol 3350."
},
{
"NDCCode": "21922-078-25",
"PackageDescription": "1 TUBE in 1 CARTON (21922-078-25) / 20 g in 1 TUBE",
"NDC11Code": "21922-0078-25",
"ProductNDC": "21922-078",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tretinoin",
"NonProprietaryName": "Tretinoin",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260326",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217832",
"LabelerName": "Encube Ethicals, Inc.",
"SubstanceName": "TRETINOIN",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2026-04-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260326",
"SamplePackage": "N",
"IndicationAndUsage": "Tretinoin cream is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.",
"Description": "Tretinoin Cream, USP are used for the topical treatment of acne vulgaris. Tretinoin Cream, USP contains tretinoin in either of three strengths, 0.1%, 0.05% or 0.025% by weight, in a hydrophilic cream vehicle of stearic acid, isopropyl myristate, polyoxyl 40 stearate, stearyl alcohol, xanthan gum, sorbic acid, butylated hydroxytoluene, and purified water. Chemically, tretinoin is all-trans-retinoic acid and has the following structure."
},
{
"NDCCode": "21922-079-25",
"PackageDescription": "1 TUBE in 1 CARTON (21922-079-25) / 20 g in 1 TUBE",
"NDC11Code": "21922-0079-25",
"ProductNDC": "21922-079",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tretinoin",
"NonProprietaryName": "Tretinoin",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250711",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217831",
"LabelerName": "Encube Ethicals, Inc.",
"SubstanceName": "TRETINOIN",
"StrengthNumber": ".25",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2026-04-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250711",
"SamplePackage": "N",
"IndicationAndUsage": "Tretinoin cream is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.",
"Description": "Tretinoin Cream, USP are used for the topical treatment of acne vulgaris. Tretinoin Cream, USP contains tretinoin in either of three strengths, 0.1%, 0.05% or 0.025% by weight, in a hydrophilic cream vehicle of stearic acid, isopropyl myristate, polyoxyl 40 stearate, stearyl alcohol, xanthan gum, sorbic acid, butylated hydroxytoluene, and purified water. Chemically, tretinoin is all-trans-retinoic acid and has the following structure."
},
{
"NDCCode": "21922-086-52",
"PackageDescription": "30 PACKET in 1 CARTON (21922-086-52) / .25 g in 1 PACKET",
"NDC11Code": "21922-0086-52",
"ProductNDC": "21922-086",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol Gel",
"NonProprietaryName": "Estradiol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250310",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218507",
"LabelerName": "Encube Ethicals, Inc.",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": ".25",
"StrengthUnit": "mg/.25g",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250310",
"SamplePackage": "N",
"IndicationAndUsage": "Estradiol gel 0.1% is an estrogen indicated for the treatment of moderate to severe vasomotor symptoms due to menopause (1.1).",
"Description": "Estradiol gel 0.1percent, is a clear, colorless gel, which is odorless when dry. It is designed to deliver sustained circulating concentrations of estradiol when applied once daily to the skin. The gel is applied to a small area (200 cm2) of the thigh in a thin layer. Estradiol gel 0.1% is available in five doses of 0.25, 0.5, 0.75, 1.0, and 1.25 grams for topical application (corresponding to 0.25, 0.5, 0.75, 1.0, and 1.25 mg estradiol, respectively).The active component of the topical gel is estradiol.Estradiol is a white crystalline powder, chemically described as estra-1,3, 5(10)-triene-3,17ß-diol. It has an empirical formula of C18H24O2 and molecular weight of 272.39. The structural formula is:. The remaining components of the gel alcohol 59.61% v/v, carbopol 974 P polymer, propylene glycol, purified water, and trolamine 99% are pharmacologically inactive."
},
{
"NDCCode": "21922-090-52",
"PackageDescription": "30 PACKET in 1 CARTON (21922-090-52) / 1.25 g in 1 PACKET",
"NDC11Code": "21922-0090-52",
"ProductNDC": "21922-090",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol Gel",
"NonProprietaryName": "Estradiol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250310",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218507",
"LabelerName": "Encube Ethicals, Inc.",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": "1.25",
"StrengthUnit": "mg/1.25g",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250310",
"SamplePackage": "N",
"IndicationAndUsage": "Estradiol gel 0.1% is an estrogen indicated for the treatment of moderate to severe vasomotor symptoms due to menopause (1.1).",
"Description": "Estradiol gel 0.1percent, is a clear, colorless gel, which is odorless when dry. It is designed to deliver sustained circulating concentrations of estradiol when applied once daily to the skin. The gel is applied to a small area (200 cm2) of the thigh in a thin layer. Estradiol gel 0.1% is available in five doses of 0.25, 0.5, 0.75, 1.0, and 1.25 grams for topical application (corresponding to 0.25, 0.5, 0.75, 1.0, and 1.25 mg estradiol, respectively).The active component of the topical gel is estradiol.Estradiol is a white crystalline powder, chemically described as estra-1,3, 5(10)-triene-3,17ß-diol. It has an empirical formula of C18H24O2 and molecular weight of 272.39. The structural formula is:. The remaining components of the gel alcohol 59.61% v/v, carbopol 974 P polymer, propylene glycol, purified water, and trolamine 99% are pharmacologically inactive."
},
{
"NDCCode": "37000-077-25",
"PackageDescription": "250 mL in 1 BOTTLE, PLASTIC (37000-077-25) ",
"NDC11Code": "37000-0077-25",
"ProductNDC": "37000-077",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Head And Shoulders",
"ProprietaryNameSuffix": "Green Apple",
"NonProprietaryName": "Pyrithione Zinc",
"DosageFormName": "LOTION/SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130901",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part358H",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"SubstanceName": "PYRITHIONE ZINC",
"StrengthNumber": "1",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20161001",
"EndMarketingDatePackage": "20210305",
"SamplePackage": "N"
},
{
"NDCCode": "51621-077-01",
"PackageDescription": "25 mL in 1 BOTTLE (51621-077-01)",
"NDC11Code": "51621-0077-01",
"ProductNDC": "51621-077",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dr.g Actifirm Real Lifting Eye",
"NonProprietaryName": "Glycerin",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150705",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "GOWOONSESANG COSMETICS CO., LTD.",
"SubstanceName": "GLYCERIN",
"StrengthNumber": "4.07",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2017-10-03"
},
{
"NDCCode": "51621-077-02",
"PackageDescription": "1 BOTTLE in 1 CARTON (51621-077-02) > 25 mL in 1 BOTTLE (51621-077-01)",
"NDC11Code": "51621-0077-02",
"ProductNDC": "51621-077",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dr.g Actifirm Real Lifting Eye",
"NonProprietaryName": "Glycerin",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150705",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "GOWOONSESANG COSMETICS CO., LTD.",
"SubstanceName": "GLYCERIN",
"StrengthNumber": "4.07",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2018-01-12",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "52959-077-25",
"PackageDescription": "25 TABLET in 1 BOTTLE (52959-077-25)",
"NDC11Code": "52959-0077-25",
"ProductNDC": "52959-077",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091123",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078558",
"LabelerName": "H.J. Harkins Company, Inc.",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of Ibuprofen Tablets, USP and other treatment options before deciding to use Ibuprofen Tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen Tablets, USP are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen Tablets, USP are indicated for relief of mild to moderate pain. Ibuprofen Tablets, USP are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of Ibuprofen Tablets, USP in children have not been conducted.",
"Description": "Ibuprofen Tablets, USP contain the active ingredient ibuprofen, which is (±) – 2 – (p – isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77° C and is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. Ibuprofen Tablets, USP, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg, and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, stearic acid, and titanium dioxide."
},
{
"NDCCode": "60429-077-25",
"PackageDescription": "25 TABLET, COATED in 1 BOTTLE, PLASTIC (60429-077-25)",
"NDC11Code": "60429-0077-25",
"ProductNDC": "60429-077",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chloroquine",
"NonProprietaryName": "Chloroquine Phosphate",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19990917",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA083082",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "CHLOROQUINE PHOSPHATE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimalarial [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-11-01"
},
{
"NDCCode": "62157-077-01",
"PackageDescription": "25 g in 1 BOTTLE (62157-077-01)",
"NDC11Code": "62157-0077-01",
"ProductNDC": "62157-077",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Anastrozole",
"DosageFormName": "POWDER",
"StartMarketingDate": "20150522",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "AX Pharmaceutical Corp",
"SubstanceName": "ANASTROZOLE",
"StrengthNumber": "24.75",
"StrengthUnit": "g/25g",
"Status": "Unfinished",
"LastUpdate": "2018-12-28",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "62750-077-11",
"PackageDescription": "25 BAR, CHEWABLE in 1 BOTTLE (62750-077-11) ",
"NDC11Code": "62750-0077-11",
"ProductNDC": "62750-077",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Zicam Cold Remedy Medicated Fruit Drops",
"NonProprietaryName": "Zinc Acetate Anhydrous And Zinc Gluconate",
"DosageFormName": "BAR, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20170401",
"EndMarketingDate": "20190810",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Matrixx Initiatives, Inc.",
"SubstanceName": "ZINC ACETATE ANHYDROUS; ZINC GLUCONATE",
"StrengthNumber": "2; 2",
"StrengthUnit": "[hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2019-08-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170401",
"EndMarketingDatePackage": "20190810",
"SamplePackage": "N"
},
{
"NDCCode": "69097-077-97",
"PackageDescription": "25 VIAL in 1 CARTON (69097-077-97) / 15 mL in 1 VIAL (69097-077-67) ",
"NDC11Code": "69097-0077-97",
"ProductNDC": "69097-077",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Phosphates",
"NonProprietaryName": "Potassium Phosphates",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217892",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "MONOBASIC POTASSIUM PHOSPHATE; DIBASIC POTASSIUM PHOSPHATE",
"StrengthNumber": "224; 236",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2025-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250206",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium phosphates injection is indicated as a source of phosphorus: 1 in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated., 2 for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated.",
"Description": "Potassium phosphates injection, USP, a phosphorus replacement product containing phosphorus 3 mmol/mL and potassium 4.4 mEq/mL. It is a sterile, non-pyrogenic, concentrated solution containing a mixture of monobasic potassium phosphate and dibasic potassium phosphate in water for injection. It is supplied as a 5 mL and 15 mL single-dose vials and a 50 mL Pharmacy Bulk Package vial. Monobasic Potassium Phosphate is chemically designated KH 2PO 4, molecular weight 136.09, white or colorless crystals or crystalline powder freely soluble in water. Dibasic Potassium Phosphate is chemically designated K 2HPO 4, molecular weight 174.18, colorless to white granular powder freely soluble in water. Each mL contains 224 mg of monobasic potassium phosphate and 236 mg of dibasic potassium phosphate. Each mL contains 3 mmol phosphorus (equivalent to 93 mg phosphorus) and 4.4 mEq potassium (equivalent to 170 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. The pH is 6.0 to 7.0. This product contains no more than 900 mcg/L of aluminum [see Warnings and Precautions (5.5)]. The osmolarity is 7.4 mOsmol/mL (calc). The solution is administered after dilution or admixing by the intravenous route."
},
{
"NDCCode": "72501-077-26",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX, UNIT-DOSE (72501-077-26) > 1 g in 1 BOTTLE, PLASTIC (72501-077-25) ",
"NDC11Code": "72501-0077-26",
"ProductNDC": "72501-077",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Iceking Refresh Armpit",
"NonProprietaryName": "Iceking Refresh Armpit",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180915",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Shanghai Iceking Biotechnology Co.,Ltd.",
"SubstanceName": "ALUMINUM CHLOROHYDRATE ANHYDROUS",
"StrengthNumber": "9",
"StrengthUnit": "g/5g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180915",
"SamplePackage": "N"
},
{
"NDCCode": "82804-077-25",
"PackageDescription": "1 BOTTLE in 1 CARTON (82804-077-25) / 25 TABLET in 1 BOTTLE",
"NDC11Code": "82804-0077-25",
"ProductNDC": "82804-077",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitroglycerin",
"NonProprietaryName": "Nitroglycerin",
"DosageFormName": "TABLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20221003",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211604",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "NITROGLYCERIN",
"StrengthNumber": ".4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2024-02-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240221",
"SamplePackage": "N",
"IndicationAndUsage": "Nitroglycerin sublingual tablets are indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.",
"Description": "Nitroglycerin sublingual tablets USP, are a stabilized sublingual compressed nitroglycerin tablet that contains 0.3 mg, 0.4 mg, or 0.6 mg nitroglycerin. The sublingual tablets also contain the inactive ingredients lactose monohydrate, glyceryl monostearate, pregelatinized corn starch, calcium stearate, and hydrophobic colloidal silica.Nitroglycerin, an organic nitrate, is a vasodilating agent. The chemical name for nitroglycerin is 1, 2, 3 propanetriol trinitrate and the chemical structure is. Molecular weight: 227.09."
},
{
"NDCCode": "21922-011-05",
"PackageDescription": "1 TUBE in 1 CARTON (21922-011-05) / 30 g in 1 TUBE",
"NDC11Code": "21922-0011-05",
"ProductNDC": "21922-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tacrolimus",
"NonProprietaryName": "Tacrolimus Ointment 0.1%",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20231013",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212387",
"LabelerName": "Encube Ethicals, Inc.",
"SubstanceName": "TACROLIMUS",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231013",
"SamplePackage": "N",
"IndicationAndUsage": "Tacrolimus ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable. Tacrolimus ointment is not indicated for children younger than 2 years of age (see boxed WARNING, WARNINGSand PRECAUTIONS: Pediatric Use).",
"Description": "Tacrolimus ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis. It is for topical dermatologic use only. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*, 26aR*]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3- methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19- epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. It has the following structural formula. Tacrolimus has an empirical formula of C44H69NO12H2O and a formula weight of 822.03. Each gram of tacrolimus ointment contains (w/w) 0.1% of tacrolimus in a base of mineral oil, paraffin, propylene carbonate, white petrolatum, and white wax."
},
{
"NDCCode": "21922-011-07",
"PackageDescription": "1 TUBE in 1 CARTON (21922-011-07) / 60 g in 1 TUBE",
"NDC11Code": "21922-0011-07",
"ProductNDC": "21922-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tacrolimus",
"NonProprietaryName": "Tacrolimus Ointment 0.1%",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20231013",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212387",
"LabelerName": "Encube Ethicals, Inc.",
"SubstanceName": "TACROLIMUS",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231013",
"SamplePackage": "N",
"IndicationAndUsage": "Tacrolimus ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable. Tacrolimus ointment is not indicated for children younger than 2 years of age (see boxed WARNING, WARNINGSand PRECAUTIONS: Pediatric Use).",
"Description": "Tacrolimus ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis. It is for topical dermatologic use only. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*, 26aR*]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3- methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19- epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. It has the following structural formula. Tacrolimus has an empirical formula of C44H69NO12H2O and a formula weight of 822.03. Each gram of tacrolimus ointment contains (w/w) 0.1% of tacrolimus in a base of mineral oil, paraffin, propylene carbonate, white petrolatum, and white wax."
},
{
"NDCCode": "21922-011-09",
"PackageDescription": "1 TUBE in 1 CARTON (21922-011-09) / 100 g in 1 TUBE",
"NDC11Code": "21922-0011-09",
"ProductNDC": "21922-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tacrolimus",
"NonProprietaryName": "Tacrolimus Ointment 0.1%",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20231013",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212387",
"LabelerName": "Encube Ethicals, Inc.",
"SubstanceName": "TACROLIMUS",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231013",
"SamplePackage": "N",
"IndicationAndUsage": "Tacrolimus ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable. Tacrolimus ointment is not indicated for children younger than 2 years of age (see boxed WARNING, WARNINGSand PRECAUTIONS: Pediatric Use).",
"Description": "Tacrolimus ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis. It is for topical dermatologic use only. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*, 26aR*]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3- methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19- epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. It has the following structural formula. Tacrolimus has an empirical formula of C44H69NO12H2O and a formula weight of 822.03. Each gram of tacrolimus ointment contains (w/w) 0.1% of tacrolimus in a base of mineral oil, paraffin, propylene carbonate, white petrolatum, and white wax."
},
{
"NDCCode": "21922-015-40",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (21922-015-40) / 50 g in 1 BOTTLE, PUMP",
"NDC11Code": "21922-0015-40",
"ProductNDC": "21922-015",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol",
"NonProprietaryName": "Estradiol",
"DosageFormName": "GEL",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20260513",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218214",
"LabelerName": "Encube Ethicals, Inc.",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": ".75",
"StrengthUnit": "mg/1.25g",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260513",
"SamplePackage": "N",
"Description": "Estradiol gel contains 0.06 percent estradiol in an absorptive hydroalcoholic gel base for topical application. It is a clear, colorless gel, which is odorless when dry. One pump depression of estradiol gel delivers 1.25 g of gel containing 0.75 mg estradiol. Estradiol is a white crystalline powder, chemically described as estra-1,3,5(10)-triene-3,17β-diol. It has an empirical formula of C18H24O2 and molecular weight of 272.39. The structural formula is. The active component of the gel is estradiol. The remaining components of the gel (purified water, alcohol (46.12%), trolamine and carbopol 974 P polymer) are pharmacologically inactive."
},
{
"NDCCode": "21922-050-05",
"PackageDescription": "1 TUBE in 1 CARTON (21922-050-05) / 30 g in 1 TUBE",
"NDC11Code": "21922-0050-05",
"ProductNDC": "21922-050",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin Phosphate And Tretinoin Gel 1.2%/0.025%",
"NonProprietaryName": "Clindamycin Phosphate And Tretinoin Gel 1.2%/0.025%",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230904",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216943",
"LabelerName": "Encube Ethicals, Inc.",
"SubstanceName": "CLINDAMYCIN PHOSPHATE; TRETINOIN",
"StrengthNumber": "10; .25",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE], Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2025-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230904",
"SamplePackage": "N",
"IndicationAndUsage": "Clindamycin phosphate and tretinoin gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older.",
"Description": "Clindamycin phosphate and tretinoin gel 1.2%/0.025%, is a fixed combination of 2 solubilized active ingredients in an aqueous-based gel. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The chemical name for clindamycin phosphate is methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate). The structural formula for clindamycin phosphate is represented below. Molecular Formula: C18H34ClN2O8PS Molecular Weight: 504.97. The chemical name for tretinoin is all-trans 3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. It is a member of the retinoid family of compounds. The structural formula for tretinoin is represented below. Molecular Formula: C20H28O2 Molecular Weight: 300.44. Clindamycin phosphate and tretinoin gel contains the following inactive ingredients: anhydrous citric acid, butylated hydroxytoluene, carbomer homopolymer (type C), edetate disodium, laureth 4, methylparaben, propylene glycol, purified water, and tromethamine."
},
{
"NDCCode": "21922-050-07",
"PackageDescription": "1 TUBE in 1 CARTON (21922-050-07) / 60 g in 1 TUBE",
"NDC11Code": "21922-0050-07",
"ProductNDC": "21922-050",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin Phosphate And Tretinoin Gel 1.2%/0.025%",
"NonProprietaryName": "Clindamycin Phosphate And Tretinoin Gel 1.2%/0.025%",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230904",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216943",
"LabelerName": "Encube Ethicals, Inc.",
"SubstanceName": "CLINDAMYCIN PHOSPHATE; TRETINOIN",
"StrengthNumber": "10; .25",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE], Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2025-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230904",
"SamplePackage": "N",
"IndicationAndUsage": "Clindamycin phosphate and tretinoin gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older.",
"Description": "Clindamycin phosphate and tretinoin gel 1.2%/0.025%, is a fixed combination of 2 solubilized active ingredients in an aqueous-based gel. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The chemical name for clindamycin phosphate is methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate). The structural formula for clindamycin phosphate is represented below. Molecular Formula: C18H34ClN2O8PS Molecular Weight: 504.97. The chemical name for tretinoin is all-trans 3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. It is a member of the retinoid family of compounds. The structural formula for tretinoin is represented below. Molecular Formula: C20H28O2 Molecular Weight: 300.44. Clindamycin phosphate and tretinoin gel contains the following inactive ingredients: anhydrous citric acid, butylated hydroxytoluene, carbomer homopolymer (type C), edetate disodium, laureth 4, methylparaben, propylene glycol, purified water, and tromethamine."
},
{
"NDCCode": "21922-052-50",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (21922-052-50) / 45 g in 1 BOTTLE, PUMP",
"NDC11Code": "21922-0052-50",
"ProductNDC": "21922-052",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adapalene And Benzoyl Peroxide Gel, 0.1%/2.5%",
"NonProprietaryName": "Adapalene And Benzoyl Peroxide Gel, 0.1%/2.5%",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230814",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206164",
"LabelerName": "Encube Ethicals, Inc.",
"SubstanceName": "ADAPALENE; BENZOYL PEROXIDE",
"StrengthNumber": "1; 25",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2026-06-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230814",
"SamplePackage": "N",
"IndicationAndUsage": "Adapalene and benzoyl peroxide gel USP, 0.1% / 2.5% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.",
"Description": "Adapalene and benzoyl peroxide gel USP, 0.1% / 2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.1% and benzoyl peroxide 2.5%. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid). It has the following structural formula. Adapalene. Molecular formula: C28H28O3 Molecular weight: 412.5. Benzoyl Peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula. Benzoyl Peroxide. Molecular formula: C14H10O4 Molecular weight: 242.23. Adapalene and benzoyl peroxide gel USP, 0.1% / 2.5% contains the following inactive ingredients: carbopol 980, d-limonene, docusate sodium solution, edetate disodium, glycerin, poloxamer 182, polysorbate 80, propylene glycol, purified water, sodium hydroxide and sorbitan monooleate."
},
{
"NDCCode": "21922-057-04",
"PackageDescription": "1 TUBE in 1 CARTON (21922-057-04) / 15 g in 1 TUBE",
"NDC11Code": "21922-0057-04",
"ProductNDC": "21922-057",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tretinoin",
"NonProprietaryName": "Tretinoin",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250306",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217587",
"LabelerName": "Encube Ethicals, Inc.",
"SubstanceName": "TRETINOIN",
"StrengthNumber": ".25",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2025-09-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250306",
"SamplePackage": "N",
"IndicationAndUsage": "Tretinoin gel is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.",
"Description": "Tretinoin Gel, USP is used for the topical treatment of acne vulgaris. Tretinoin Gel, USP contains tretinoin (retinoic acid, vitamin A acid) in either of two strengths, 0.025% or 0.01% by weight, in a gel vehicle of butylated hydroxytoluene, hydroxypropyl cellulose, dehydrated alcohol and purified water. Chemically, tretinoin is all-trans-retinoic acid and has the following structure."
},
{
"NDCCode": "21922-057-06",
"PackageDescription": "1 TUBE in 1 CARTON (21922-057-06) / 45 g in 1 TUBE",
"NDC11Code": "21922-0057-06",
"ProductNDC": "21922-057",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tretinoin",
"NonProprietaryName": "Tretinoin",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250306",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217587",
"LabelerName": "Encube Ethicals, Inc.",
"SubstanceName": "TRETINOIN",
"StrengthNumber": ".25",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2025-09-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250306",
"SamplePackage": "N",
"IndicationAndUsage": "Tretinoin gel is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.",
"Description": "Tretinoin Gel, USP is used for the topical treatment of acne vulgaris. Tretinoin Gel, USP contains tretinoin (retinoic acid, vitamin A acid) in either of two strengths, 0.025% or 0.01% by weight, in a gel vehicle of butylated hydroxytoluene, hydroxypropyl cellulose, dehydrated alcohol and purified water. Chemically, tretinoin is all-trans-retinoic acid and has the following structure."
},
{
"NDCCode": "21922-062-04",
"PackageDescription": "1 TUBE in 1 CARTON (21922-062-04) / 15 g in 1 TUBE",
"NDC11Code": "21922-0062-04",
"ProductNDC": "21922-062",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240316",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208848",
"LabelerName": "Encube Ethicals, Inc.",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240316",
"SamplePackage": "N",
"IndicationAndUsage": "Triamcinolone acetonide cream 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.",
"Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone Acetonide Cream, USP contains Triamcinolone Acetonide [Pregna- 1,4- diene -3,20- dione,9-fluoro-11,21- dihydroxy-16,17- [(1- methylethylidene)bis-(oxy)]-, (11β,16α)-], with the empirical formula C24H31FO6 and molecular weight 434.50. CAS 76-25-5. Triamcinolone Acetonide Cream USP, 0.1% contains: 1 mg of triamcinolone acetonide per gram in a base containing emulsifying wax, cetyl alcohol, isopropyl palmitate, sorbitol solution, glycerin, lactic acid, benzyl alcohol and purified water."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>21922-077-25</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (21922-077-25) / 20 g in 1 TUBE</PackageDescription>
<NDC11Code>21922-0077-25</NDC11Code>
<ProductNDC>21922-077</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tretinoin</ProprietaryName>
<NonProprietaryName>Tretinoin</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260213</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217833</ApplicationNumber>
<LabelerName>Encube Ethicals, Inc.</LabelerName>
<SubstanceName>TRETINOIN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tretinoin cream is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.</IndicationAndUsage>
<Description>Tretinoin Cream, USP are used for the topical treatment of acne vulgaris. Tretinoin Cream, USP contains tretinoin in either of three strengths, 0.1%, 0.05% or 0.025% by weight, in a hydrophilic cream vehicle of stearic acid, isopropyl myristate, polyoxyl 40 stearate, stearyl alcohol, xanthan gum, sorbic acid, butylated hydroxytoluene, and purified water. Chemically, tretinoin is all-trans-retinoic acid and has the following structure.</Description>
</NDC>
<NDC>
<NDCCode>21922-077-06</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (21922-077-06) / 45 g in 1 TUBE</PackageDescription>
<NDC11Code>21922-0077-06</NDC11Code>
<ProductNDC>21922-077</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tretinoin</ProprietaryName>
<NonProprietaryName>Tretinoin</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260213</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217833</ApplicationNumber>
<LabelerName>Encube Ethicals, Inc.</LabelerName>
<SubstanceName>TRETINOIN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tretinoin cream is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.</IndicationAndUsage>
<Description>Tretinoin Cream, USP are used for the topical treatment of acne vulgaris. Tretinoin Cream, USP contains tretinoin in either of three strengths, 0.1%, 0.05% or 0.025% by weight, in a hydrophilic cream vehicle of stearic acid, isopropyl myristate, polyoxyl 40 stearate, stearyl alcohol, xanthan gum, sorbic acid, butylated hydroxytoluene, and purified water. Chemically, tretinoin is all-trans-retinoic acid and has the following structure.</Description>
</NDC>
<NDC>
<NDCCode>21922-019-52</NDCCode>
<PackageDescription>30 PACKET in 1 CARTON (21922-019-52) / 25 g in 1 PACKET</PackageDescription>
<NDC11Code>21922-0019-52</NDC11Code>
<ProductNDC>21922-019</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Testosterone Gel, 1%</ProprietaryName>
<NonProprietaryName>Testosterone Gel, 1%</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20210110</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212984</ApplicationNumber>
<LabelerName>Encube Ethicals, Inc.</LabelerName>
<SubstanceName>TESTOSTERONE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-10-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240812</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Testosterone gel, 1% is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: : 1 Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range. , 2 Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations, but have gonadotropins in the normal or low range. .</IndicationAndUsage>
<Description>Testosterone gel, 1% is a clear, colorless to yellowish hydroalcoholic gel containing testosterone, USP. The active pharmacologic ingredient in testosterone gel 1% is testosterone, USP an androgen. Testosterone, USP is a white to practically white crystalline powder chemically described as 17-beta hydroxyandrost-4-en-3-one. The structural formula is. Pharmacologically inactive ingredients in testosterone gel, 1% are carbomer 980, ethyl alcohol 67.0%, isopropyl myristate, purified water, and sodium hydroxide. These ingredients are not pharmacologically active.</Description>
</NDC>
<NDC>
<NDCCode>21922-044-25</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (21922-044-25) / 20 g in 1 TUBE</PackageDescription>
<NDC11Code>21922-0044-25</NDC11Code>
<ProductNDC>21922-044</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium Topical Gel, 1%</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200811</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210986</ApplicationNumber>
<LabelerName>Encube Ethicals, Inc.</LabelerName>
<SubstanceName>DICLOFENAC SODIUM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the temporary relief of arthritis pain ONLY in the following areas: hand, wrist, elbow (upper body areas)foot, ankle, knee (lower body areas). this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>21922-061-22</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (21922-061-22) / 25 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>21922-0061-22</NDC11Code>
<ProductNDC>21922-061</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240610</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076977</ApplicationNumber>
<LabelerName>Encube Ethicals, Inc.</LabelerName>
<SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobetasol Propionate Topical Solution, 0.05% is indicated for short-term topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 mL/week because of the potential for the drug to suppress the HPA axis. This product is not recommended for use in pediatric patients under 12 years of age.</IndicationAndUsage>
<Description>Clobetasol Propionate Topical Solution USP, 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is (11β,16β)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)pregna-1,4-diene-3,20-dione, and it has the following structural formula. Clobetasol propionate has the molecular formula C25H32ClFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol Propionate Topical Solution USP, 0.05% contains clobetasol propionate 0.5 mg/g in a base of carbopol 974P, isopropyl alcohol (39.3%), purified water and sodium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>21922-073-25</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (21922-073-25) / 22 g in 1 TUBE</PackageDescription>
<NDC11Code>21922-0073-25</NDC11Code>
<ProductNDC>21922-073</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mupirocin</ProprietaryName>
<NonProprietaryName>Mupirocin</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250516</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217943</ApplicationNumber>
<LabelerName>Encube Ethicals, Inc.</LabelerName>
<SubstanceName>MUPIROCIN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250516</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mupirocin Ointment USP, 2% is indicated for the topical treatment of impetigo due to susceptible isolates of Staphylococcus aureus(S. aureus)and Streptococcus pyogenes(S. pyogenes).</IndicationAndUsage>
<Description>Mupirocin Ointment USP, 2% contains the RNA synthetase inhibitor antibacterial, mupirocin, USP. The chemical name is (E)- (2S,3R,4R,5S)-5-[ (2S,3S,4S,5S)-2,3-epoxy-5-hydroxy-4-methylhexyl] tetrahydro-3,4-dihydroxy-β-methyl-2 H-pyran-2-crotonic acid, ester with 9-hydroxynonanoic acid. The molecular formula of mupirocin, USP is C 26H 44O 9, and the molecular weight is 500.6. The structural formula of mupirocin, USP is:. Figure 1. Structure of Mupirocin, USP. Each gram of Mupirocin Ointment USP, 2% contains 20 mg mupirocin, USP in a water-miscible ointment base (polyethylene glycol ointment, NF) consisting of polyethylene glycol 400 and polyethylene glycol 3350.</Description>
</NDC>
<NDC>
<NDCCode>21922-078-25</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (21922-078-25) / 20 g in 1 TUBE</PackageDescription>
<NDC11Code>21922-0078-25</NDC11Code>
<ProductNDC>21922-078</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tretinoin</ProprietaryName>
<NonProprietaryName>Tretinoin</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260326</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217832</ApplicationNumber>
<LabelerName>Encube Ethicals, Inc.</LabelerName>
<SubstanceName>TRETINOIN</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260326</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tretinoin cream is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.</IndicationAndUsage>
<Description>Tretinoin Cream, USP are used for the topical treatment of acne vulgaris. Tretinoin Cream, USP contains tretinoin in either of three strengths, 0.1%, 0.05% or 0.025% by weight, in a hydrophilic cream vehicle of stearic acid, isopropyl myristate, polyoxyl 40 stearate, stearyl alcohol, xanthan gum, sorbic acid, butylated hydroxytoluene, and purified water. Chemically, tretinoin is all-trans-retinoic acid and has the following structure.</Description>
</NDC>
<NDC>
<NDCCode>21922-079-25</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (21922-079-25) / 20 g in 1 TUBE</PackageDescription>
<NDC11Code>21922-0079-25</NDC11Code>
<ProductNDC>21922-079</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tretinoin</ProprietaryName>
<NonProprietaryName>Tretinoin</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250711</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217831</ApplicationNumber>
<LabelerName>Encube Ethicals, Inc.</LabelerName>
<SubstanceName>TRETINOIN</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250711</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tretinoin cream is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.</IndicationAndUsage>
<Description>Tretinoin Cream, USP are used for the topical treatment of acne vulgaris. Tretinoin Cream, USP contains tretinoin in either of three strengths, 0.1%, 0.05% or 0.025% by weight, in a hydrophilic cream vehicle of stearic acid, isopropyl myristate, polyoxyl 40 stearate, stearyl alcohol, xanthan gum, sorbic acid, butylated hydroxytoluene, and purified water. Chemically, tretinoin is all-trans-retinoic acid and has the following structure.</Description>
</NDC>
<NDC>
<NDCCode>21922-086-52</NDCCode>
<PackageDescription>30 PACKET in 1 CARTON (21922-086-52) / .25 g in 1 PACKET</PackageDescription>
<NDC11Code>21922-0086-52</NDC11Code>
<ProductNDC>21922-086</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estradiol Gel</ProprietaryName>
<NonProprietaryName>Estradiol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250310</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218507</ApplicationNumber>
<LabelerName>Encube Ethicals, Inc.</LabelerName>
<SubstanceName>ESTRADIOL</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/.25g</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250310</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Estradiol gel 0.1% is an estrogen indicated for the treatment of moderate to severe vasomotor symptoms due to menopause (1.1).</IndicationAndUsage>
<Description>Estradiol gel 0.1percent, is a clear, colorless gel, which is odorless when dry. It is designed to deliver sustained circulating concentrations of estradiol when applied once daily to the skin. The gel is applied to a small area (200 cm2) of the thigh in a thin layer. Estradiol gel 0.1% is available in five doses of 0.25, 0.5, 0.75, 1.0, and 1.25 grams for topical application (corresponding to 0.25, 0.5, 0.75, 1.0, and 1.25 mg estradiol, respectively).The active component of the topical gel is estradiol.Estradiol is a white crystalline powder, chemically described as estra-1,3, 5(10)-triene-3,17ß-diol. It has an empirical formula of C18H24O2 and molecular weight of 272.39. The structural formula is:. The remaining components of the gel alcohol 59.61% v/v, carbopol 974 P polymer, propylene glycol, purified water, and trolamine 99% are pharmacologically inactive.</Description>
</NDC>
<NDC>
<NDCCode>21922-090-52</NDCCode>
<PackageDescription>30 PACKET in 1 CARTON (21922-090-52) / 1.25 g in 1 PACKET</PackageDescription>
<NDC11Code>21922-0090-52</NDC11Code>
<ProductNDC>21922-090</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estradiol Gel</ProprietaryName>
<NonProprietaryName>Estradiol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250310</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218507</ApplicationNumber>
<LabelerName>Encube Ethicals, Inc.</LabelerName>
<SubstanceName>ESTRADIOL</SubstanceName>
<StrengthNumber>1.25</StrengthNumber>
<StrengthUnit>mg/1.25g</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250310</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Estradiol gel 0.1% is an estrogen indicated for the treatment of moderate to severe vasomotor symptoms due to menopause (1.1).</IndicationAndUsage>
<Description>Estradiol gel 0.1percent, is a clear, colorless gel, which is odorless when dry. It is designed to deliver sustained circulating concentrations of estradiol when applied once daily to the skin. The gel is applied to a small area (200 cm2) of the thigh in a thin layer. Estradiol gel 0.1% is available in five doses of 0.25, 0.5, 0.75, 1.0, and 1.25 grams for topical application (corresponding to 0.25, 0.5, 0.75, 1.0, and 1.25 mg estradiol, respectively).The active component of the topical gel is estradiol.Estradiol is a white crystalline powder, chemically described as estra-1,3, 5(10)-triene-3,17ß-diol. It has an empirical formula of C18H24O2 and molecular weight of 272.39. The structural formula is:. The remaining components of the gel alcohol 59.61% v/v, carbopol 974 P polymer, propylene glycol, purified water, and trolamine 99% are pharmacologically inactive.</Description>
</NDC>
<NDC>
<NDCCode>37000-077-25</NDCCode>
<PackageDescription>250 mL in 1 BOTTLE, PLASTIC (37000-077-25) </PackageDescription>
<NDC11Code>37000-0077-25</NDC11Code>
<ProductNDC>37000-077</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Head And Shoulders</ProprietaryName>
<ProprietaryNameSuffix>Green Apple</ProprietaryNameSuffix>
<NonProprietaryName>Pyrithione Zinc</NonProprietaryName>
<DosageFormName>LOTION/SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130901</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part358H</ApplicationNumber>
<LabelerName>The Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>PYRITHIONE ZINC</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161001</StartMarketingDatePackage>
<EndMarketingDatePackage>20210305</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>51621-077-01</NDCCode>
<PackageDescription>25 mL in 1 BOTTLE (51621-077-01)</PackageDescription>
<NDC11Code>51621-0077-01</NDC11Code>
<ProductNDC>51621-077</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dr.g Actifirm Real Lifting Eye</ProprietaryName>
<NonProprietaryName>Glycerin</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150705</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>GOWOONSESANG COSMETICS CO., LTD.</LabelerName>
<SubstanceName>GLYCERIN</SubstanceName>
<StrengthNumber>4.07</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-10-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>51621-077-02</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (51621-077-02) > 25 mL in 1 BOTTLE (51621-077-01)</PackageDescription>
<NDC11Code>51621-0077-02</NDC11Code>
<ProductNDC>51621-077</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dr.g Actifirm Real Lifting Eye</ProprietaryName>
<NonProprietaryName>Glycerin</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150705</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>GOWOONSESANG COSMETICS CO., LTD.</LabelerName>
<SubstanceName>GLYCERIN</SubstanceName>
<StrengthNumber>4.07</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-01-12</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>52959-077-25</NDCCode>
<PackageDescription>25 TABLET in 1 BOTTLE (52959-077-25)</PackageDescription>
<NDC11Code>52959-0077-25</NDC11Code>
<ProductNDC>52959-077</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091123</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078558</ApplicationNumber>
<LabelerName>H.J. Harkins Company, Inc.</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of Ibuprofen Tablets, USP and other treatment options before deciding to use Ibuprofen Tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen Tablets, USP are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen Tablets, USP are indicated for relief of mild to moderate pain. Ibuprofen Tablets, USP are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of Ibuprofen Tablets, USP in children have not been conducted.</IndicationAndUsage>
<Description>Ibuprofen Tablets, USP contain the active ingredient ibuprofen, which is (±) – 2 – (p – isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77° C and is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. Ibuprofen Tablets, USP, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg, and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, stearic acid, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>60429-077-25</NDCCode>
<PackageDescription>25 TABLET, COATED in 1 BOTTLE, PLASTIC (60429-077-25)</PackageDescription>
<NDC11Code>60429-0077-25</NDC11Code>
<ProductNDC>60429-077</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chloroquine</ProprietaryName>
<NonProprietaryName>Chloroquine Phosphate</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19990917</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA083082</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>CHLOROQUINE PHOSPHATE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimalarial [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-11-01</LastUpdate>
</NDC>
<NDC>
<NDCCode>62157-077-01</NDCCode>
<PackageDescription>25 g in 1 BOTTLE (62157-077-01)</PackageDescription>
<NDC11Code>62157-0077-01</NDC11Code>
<ProductNDC>62157-077</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Anastrozole</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20150522</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>AX Pharmaceutical Corp</LabelerName>
<SubstanceName>ANASTROZOLE</SubstanceName>
<StrengthNumber>24.75</StrengthNumber>
<StrengthUnit>g/25g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2018-12-28</LastUpdate>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>62750-077-11</NDCCode>
<PackageDescription>25 BAR, CHEWABLE in 1 BOTTLE (62750-077-11) </PackageDescription>
<NDC11Code>62750-0077-11</NDC11Code>
<ProductNDC>62750-077</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Zicam Cold Remedy Medicated Fruit Drops</ProprietaryName>
<NonProprietaryName>Zinc Acetate Anhydrous And Zinc Gluconate</NonProprietaryName>
<DosageFormName>BAR, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170401</StartMarketingDate>
<EndMarketingDate>20190810</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Matrixx Initiatives, Inc.</LabelerName>
<SubstanceName>ZINC ACETATE ANHYDROUS; ZINC GLUCONATE</SubstanceName>
<StrengthNumber>2; 2</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-08-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170401</StartMarketingDatePackage>
<EndMarketingDatePackage>20190810</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69097-077-97</NDCCode>
<PackageDescription>25 VIAL in 1 CARTON (69097-077-97) / 15 mL in 1 VIAL (69097-077-67) </PackageDescription>
<NDC11Code>69097-0077-97</NDC11Code>
<ProductNDC>69097-077</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Phosphates</ProprietaryName>
<NonProprietaryName>Potassium Phosphates</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217892</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>MONOBASIC POTASSIUM PHOSPHATE; DIBASIC POTASSIUM PHOSPHATE</SubstanceName>
<StrengthNumber>224; 236</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium phosphates injection is indicated as a source of phosphorus: 1 in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated., 2 for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated.</IndicationAndUsage>
<Description>Potassium phosphates injection, USP, a phosphorus replacement product containing phosphorus 3 mmol/mL and potassium 4.4 mEq/mL. It is a sterile, non-pyrogenic, concentrated solution containing a mixture of monobasic potassium phosphate and dibasic potassium phosphate in water for injection. It is supplied as a 5 mL and 15 mL single-dose vials and a 50 mL Pharmacy Bulk Package vial. Monobasic Potassium Phosphate is chemically designated KH 2PO 4, molecular weight 136.09, white or colorless crystals or crystalline powder freely soluble in water. Dibasic Potassium Phosphate is chemically designated K 2HPO 4, molecular weight 174.18, colorless to white granular powder freely soluble in water. Each mL contains 224 mg of monobasic potassium phosphate and 236 mg of dibasic potassium phosphate. Each mL contains 3 mmol phosphorus (equivalent to 93 mg phosphorus) and 4.4 mEq potassium (equivalent to 170 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. The pH is 6.0 to 7.0. This product contains no more than 900 mcg/L of aluminum [see Warnings and Precautions (5.5)]. The osmolarity is 7.4 mOsmol/mL (calc). The solution is administered after dilution or admixing by the intravenous route.</Description>
</NDC>
<NDC>
<NDCCode>72501-077-26</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX, UNIT-DOSE (72501-077-26) > 1 g in 1 BOTTLE, PLASTIC (72501-077-25) </PackageDescription>
<NDC11Code>72501-0077-26</NDC11Code>
<ProductNDC>72501-077</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Iceking Refresh Armpit</ProprietaryName>
<NonProprietaryName>Iceking Refresh Armpit</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180915</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Shanghai Iceking Biotechnology Co.,Ltd.</LabelerName>
<SubstanceName>ALUMINUM CHLOROHYDRATE ANHYDROUS</SubstanceName>
<StrengthNumber>9</StrengthNumber>
<StrengthUnit>g/5g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>82804-077-25</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (82804-077-25) / 25 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>82804-0077-25</NDC11Code>
<ProductNDC>82804-077</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitroglycerin</ProprietaryName>
<NonProprietaryName>Nitroglycerin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20221003</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211604</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>NITROGLYCERIN</SubstanceName>
<StrengthNumber>.4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nitroglycerin sublingual tablets are indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.</IndicationAndUsage>
<Description>Nitroglycerin sublingual tablets USP, are a stabilized sublingual compressed nitroglycerin tablet that contains 0.3 mg, 0.4 mg, or 0.6 mg nitroglycerin. The sublingual tablets also contain the inactive ingredients lactose monohydrate, glyceryl monostearate, pregelatinized corn starch, calcium stearate, and hydrophobic colloidal silica.Nitroglycerin, an organic nitrate, is a vasodilating agent. The chemical name for nitroglycerin is 1, 2, 3 propanetriol trinitrate and the chemical structure is. Molecular weight: 227.09.</Description>
</NDC>
<NDC>
<NDCCode>21922-011-05</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (21922-011-05) / 30 g in 1 TUBE</PackageDescription>
<NDC11Code>21922-0011-05</NDC11Code>
<ProductNDC>21922-011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tacrolimus</ProprietaryName>
<NonProprietaryName>Tacrolimus Ointment 0.1%</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20231013</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212387</ApplicationNumber>
<LabelerName>Encube Ethicals, Inc.</LabelerName>
<SubstanceName>TACROLIMUS</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231013</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tacrolimus ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable. Tacrolimus ointment is not indicated for children younger than 2 years of age (see boxed WARNING, WARNINGSand PRECAUTIONS: Pediatric Use).</IndicationAndUsage>
<Description>Tacrolimus ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis. It is for topical dermatologic use only. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*, 26aR*]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3- methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19- epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. It has the following structural formula. Tacrolimus has an empirical formula of C44H69NO12H2O and a formula weight of 822.03. Each gram of tacrolimus ointment contains (w/w) 0.1% of tacrolimus in a base of mineral oil, paraffin, propylene carbonate, white petrolatum, and white wax.</Description>
</NDC>
<NDC>
<NDCCode>21922-011-07</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (21922-011-07) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>21922-0011-07</NDC11Code>
<ProductNDC>21922-011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tacrolimus</ProprietaryName>
<NonProprietaryName>Tacrolimus Ointment 0.1%</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20231013</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212387</ApplicationNumber>
<LabelerName>Encube Ethicals, Inc.</LabelerName>
<SubstanceName>TACROLIMUS</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231013</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tacrolimus ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable. Tacrolimus ointment is not indicated for children younger than 2 years of age (see boxed WARNING, WARNINGSand PRECAUTIONS: Pediatric Use).</IndicationAndUsage>
<Description>Tacrolimus ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis. It is for topical dermatologic use only. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*, 26aR*]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3- methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19- epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. It has the following structural formula. Tacrolimus has an empirical formula of C44H69NO12H2O and a formula weight of 822.03. Each gram of tacrolimus ointment contains (w/w) 0.1% of tacrolimus in a base of mineral oil, paraffin, propylene carbonate, white petrolatum, and white wax.</Description>
</NDC>
<NDC>
<NDCCode>21922-011-09</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (21922-011-09) / 100 g in 1 TUBE</PackageDescription>
<NDC11Code>21922-0011-09</NDC11Code>
<ProductNDC>21922-011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tacrolimus</ProprietaryName>
<NonProprietaryName>Tacrolimus Ointment 0.1%</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20231013</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212387</ApplicationNumber>
<LabelerName>Encube Ethicals, Inc.</LabelerName>
<SubstanceName>TACROLIMUS</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231013</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tacrolimus ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable. Tacrolimus ointment is not indicated for children younger than 2 years of age (see boxed WARNING, WARNINGSand PRECAUTIONS: Pediatric Use).</IndicationAndUsage>
<Description>Tacrolimus ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis. It is for topical dermatologic use only. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*, 26aR*]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3- methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19- epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. It has the following structural formula. Tacrolimus has an empirical formula of C44H69NO12H2O and a formula weight of 822.03. Each gram of tacrolimus ointment contains (w/w) 0.1% of tacrolimus in a base of mineral oil, paraffin, propylene carbonate, white petrolatum, and white wax.</Description>
</NDC>
<NDC>
<NDCCode>21922-015-40</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (21922-015-40) / 50 g in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>21922-0015-40</NDC11Code>
<ProductNDC>21922-015</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estradiol</ProprietaryName>
<NonProprietaryName>Estradiol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20260513</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218214</ApplicationNumber>
<LabelerName>Encube Ethicals, Inc.</LabelerName>
<SubstanceName>ESTRADIOL</SubstanceName>
<StrengthNumber>.75</StrengthNumber>
<StrengthUnit>mg/1.25g</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260513</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Estradiol gel contains 0.06 percent estradiol in an absorptive hydroalcoholic gel base for topical application. It is a clear, colorless gel, which is odorless when dry. One pump depression of estradiol gel delivers 1.25 g of gel containing 0.75 mg estradiol. Estradiol is a white crystalline powder, chemically described as estra-1,3,5(10)-triene-3,17β-diol. It has an empirical formula of C18H24O2 and molecular weight of 272.39. The structural formula is. The active component of the gel is estradiol. The remaining components of the gel (purified water, alcohol (46.12%), trolamine and carbopol 974 P polymer) are pharmacologically inactive.</Description>
</NDC>
<NDC>
<NDCCode>21922-050-05</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (21922-050-05) / 30 g in 1 TUBE</PackageDescription>
<NDC11Code>21922-0050-05</NDC11Code>
<ProductNDC>21922-050</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindamycin Phosphate And Tretinoin Gel 1.2%/0.025%</ProprietaryName>
<NonProprietaryName>Clindamycin Phosphate And Tretinoin Gel 1.2%/0.025%</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230904</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216943</ApplicationNumber>
<LabelerName>Encube Ethicals, Inc.</LabelerName>
<SubstanceName>CLINDAMYCIN PHOSPHATE; TRETINOIN</SubstanceName>
<StrengthNumber>10; .25</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE], Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230904</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clindamycin phosphate and tretinoin gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older.</IndicationAndUsage>
<Description>Clindamycin phosphate and tretinoin gel 1.2%/0.025%, is a fixed combination of 2 solubilized active ingredients in an aqueous-based gel. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The chemical name for clindamycin phosphate is methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate). The structural formula for clindamycin phosphate is represented below. Molecular Formula: C18H34ClN2O8PS Molecular Weight: 504.97. The chemical name for tretinoin is all-trans 3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. It is a member of the retinoid family of compounds. The structural formula for tretinoin is represented below. Molecular Formula: C20H28O2 Molecular Weight: 300.44. Clindamycin phosphate and tretinoin gel contains the following inactive ingredients: anhydrous citric acid, butylated hydroxytoluene, carbomer homopolymer (type C), edetate disodium, laureth 4, methylparaben, propylene glycol, purified water, and tromethamine.</Description>
</NDC>
<NDC>
<NDCCode>21922-050-07</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (21922-050-07) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>21922-0050-07</NDC11Code>
<ProductNDC>21922-050</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindamycin Phosphate And Tretinoin Gel 1.2%/0.025%</ProprietaryName>
<NonProprietaryName>Clindamycin Phosphate And Tretinoin Gel 1.2%/0.025%</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230904</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216943</ApplicationNumber>
<LabelerName>Encube Ethicals, Inc.</LabelerName>
<SubstanceName>CLINDAMYCIN PHOSPHATE; TRETINOIN</SubstanceName>
<StrengthNumber>10; .25</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE], Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230904</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clindamycin phosphate and tretinoin gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older.</IndicationAndUsage>
<Description>Clindamycin phosphate and tretinoin gel 1.2%/0.025%, is a fixed combination of 2 solubilized active ingredients in an aqueous-based gel. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The chemical name for clindamycin phosphate is methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate). The structural formula for clindamycin phosphate is represented below. Molecular Formula: C18H34ClN2O8PS Molecular Weight: 504.97. The chemical name for tretinoin is all-trans 3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. It is a member of the retinoid family of compounds. The structural formula for tretinoin is represented below. Molecular Formula: C20H28O2 Molecular Weight: 300.44. Clindamycin phosphate and tretinoin gel contains the following inactive ingredients: anhydrous citric acid, butylated hydroxytoluene, carbomer homopolymer (type C), edetate disodium, laureth 4, methylparaben, propylene glycol, purified water, and tromethamine.</Description>
</NDC>
<NDC>
<NDCCode>21922-052-50</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (21922-052-50) / 45 g in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>21922-0052-50</NDC11Code>
<ProductNDC>21922-052</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Adapalene And Benzoyl Peroxide Gel, 0.1%/2.5%</ProprietaryName>
<NonProprietaryName>Adapalene And Benzoyl Peroxide Gel, 0.1%/2.5%</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230814</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206164</ApplicationNumber>
<LabelerName>Encube Ethicals, Inc.</LabelerName>
<SubstanceName>ADAPALENE; BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>1; 25</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230814</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adapalene and benzoyl peroxide gel USP, 0.1% / 2.5% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.</IndicationAndUsage>
<Description>Adapalene and benzoyl peroxide gel USP, 0.1% / 2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.1% and benzoyl peroxide 2.5%. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid). It has the following structural formula. Adapalene. Molecular formula: C28H28O3 Molecular weight: 412.5. Benzoyl Peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula. Benzoyl Peroxide. Molecular formula: C14H10O4 Molecular weight: 242.23. Adapalene and benzoyl peroxide gel USP, 0.1% / 2.5% contains the following inactive ingredients: carbopol 980, d-limonene, docusate sodium solution, edetate disodium, glycerin, poloxamer 182, polysorbate 80, propylene glycol, purified water, sodium hydroxide and sorbitan monooleate.</Description>
</NDC>
<NDC>
<NDCCode>21922-057-04</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (21922-057-04) / 15 g in 1 TUBE</PackageDescription>
<NDC11Code>21922-0057-04</NDC11Code>
<ProductNDC>21922-057</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tretinoin</ProprietaryName>
<NonProprietaryName>Tretinoin</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250306</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217587</ApplicationNumber>
<LabelerName>Encube Ethicals, Inc.</LabelerName>
<SubstanceName>TRETINOIN</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250306</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tretinoin gel is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.</IndicationAndUsage>
<Description>Tretinoin Gel, USP is used for the topical treatment of acne vulgaris. Tretinoin Gel, USP contains tretinoin (retinoic acid, vitamin A acid) in either of two strengths, 0.025% or 0.01% by weight, in a gel vehicle of butylated hydroxytoluene, hydroxypropyl cellulose, dehydrated alcohol and purified water. Chemically, tretinoin is all-trans-retinoic acid and has the following structure.</Description>
</NDC>
<NDC>
<NDCCode>21922-057-06</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (21922-057-06) / 45 g in 1 TUBE</PackageDescription>
<NDC11Code>21922-0057-06</NDC11Code>
<ProductNDC>21922-057</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tretinoin</ProprietaryName>
<NonProprietaryName>Tretinoin</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250306</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217587</ApplicationNumber>
<LabelerName>Encube Ethicals, Inc.</LabelerName>
<SubstanceName>TRETINOIN</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250306</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tretinoin gel is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.</IndicationAndUsage>
<Description>Tretinoin Gel, USP is used for the topical treatment of acne vulgaris. Tretinoin Gel, USP contains tretinoin (retinoic acid, vitamin A acid) in either of two strengths, 0.025% or 0.01% by weight, in a gel vehicle of butylated hydroxytoluene, hydroxypropyl cellulose, dehydrated alcohol and purified water. Chemically, tretinoin is all-trans-retinoic acid and has the following structure.</Description>
</NDC>
<NDC>
<NDCCode>21922-062-04</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (21922-062-04) / 15 g in 1 TUBE</PackageDescription>
<NDC11Code>21922-0062-04</NDC11Code>
<ProductNDC>21922-062</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240316</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208848</ApplicationNumber>
<LabelerName>Encube Ethicals, Inc.</LabelerName>
<SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240316</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Triamcinolone acetonide cream 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.</IndicationAndUsage>
<Description>The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone Acetonide Cream, USP contains Triamcinolone Acetonide [Pregna- 1,4- diene -3,20- dione,9-fluoro-11,21- dihydroxy-16,17- [(1- methylethylidene)bis-(oxy)]-, (11β,16α)-], with the empirical formula C24H31FO6 and molecular weight 434.50. CAS 76-25-5. Triamcinolone Acetonide Cream USP, 0.1% contains: 1 mg of triamcinolone acetonide per gram in a base containing emulsifying wax, cetyl alcohol, isopropyl palmitate, sorbitol solution, glycerin, lactic acid, benzyl alcohol and purified water.</Description>
</NDC>
</NDCList>