{
"NDC": [
{
"NDCCode": "50320-111-58",
"PackageDescription": "500 mL in 1 CANISTER (50320-111-58)",
"NDC11Code": "50320-0111-58",
"ProductNDC": "50320-111",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Monk",
"ProprietaryNameSuffix": "Hand Sanitizing Wipes",
"NonProprietaryName": "Benzethonium Chloride",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100106",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333",
"LabelerName": "National Towelette Company",
"SubstanceName": "BENZETHONIUM CHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mL/1000mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "44087-1115-1",
"PackageDescription": "1 PACKAGE in 1 CARTON (44087-1115-1) / .5 mL in 1 PACKAGE",
"NDC11Code": "44087-1115-01",
"ProductNDC": "44087-1115",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gonal-f Rff Redi-ject",
"NonProprietaryName": "Follitropin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20131016",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA021684",
"LabelerName": "EMD Serono, Inc.",
"SubstanceName": "FOLLITROPIN",
"StrengthNumber": "300",
"StrengthUnit": "[iU]/.5mL",
"Pharm_Classes": "Gonadotropin [EPC], Gonadotropins [CS]",
"Status": "Active",
"LastUpdate": "2025-04-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20131016",
"SamplePackage": "N",
"IndicationAndUsage": "GONAL-f® RFF Redi-ject® is a prefilled gonadotropin-containing auto-injection device indicated for: 1 Induction of ovulation and pregnancy in oligo-anovulatory women in whom the cause of infertility is functional and not due to primary ovarian failure (1.1), 2 Development of multiple follicles in ovulatory women as part of an Assisted Reproductive Technology (ART) cycle (1.2).",
"Description": "Follitropin alfa, a gonadotropin [human follicle stimulating hormone (hFSH)], is a glycoprotein hormone produced by recombinant DNA technology in a Chinese Hamster Ovary (CHO) cell line. It has a dimeric structure consisting of two glycoprotein subunits (alpha and beta). The alpha and beta subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structures are indistinguishable from those of human follicle stimulating hormone. The molecular weight is approximately 31 kDa (14 kDa for alpha subunit and 17 kDa for beta subunit). GONAL-f® RFF Redi-ject® (follitropin alfa) injection is a sterile, clear and colorless to slightly yellow solution in disposable, prefilled single-patient-use pen intended for the subcutaneous use. Each GONAL-f® RFF Redi-ject® pen delivers 300 International Units (22 mcg) follitropin alfa in 0.48 mL and the inactive ingredients: dibasic sodium phosphate (0.43 mg), m-cresol (1.47 mg), methionine (0.05 mg), monobasic sodium phosphate (0.19 mg), poloxamer (0.05 mg), sucrose (29.47 mg) and Water for Injection USP. Phosphoric acid and/or sodium hydroxide may be used to adjust the pH to 7. Each GONAL-f® RFF Redi-ject® pen delivers 450 International Units (33 mcg) follitropin alfa in 0.72 mL and the inactive ingredients: dibasic sodium phosphate (0.65 mg), m-cresol (2.21 mg), methionine (0.07 mg), monobasic sodium phosphate (0.29 mg), poloxamer (0.07 mg), sucrose (44.20 mg) and Water for Injection USP. Phosphoric acid and/or sodium hydroxide may be used to adjust the pH to 7. Each GONAL-f® RFF Redi-ject® pen delivers 900 International Units (66 mcg) follitropin alfa in 1.44 mL and the inactive ingredients: dibasic sodium phosphate (1.3 mg), m-cresol (4.42 mg), methionine (0.15 mg), monobasic sodium phosphate (0.58 mg), poloxamer (0.15 mg), sucrose (88.41 mg) and Water for Injection USP. Phosphoric acid and/or sodium hydroxide may be used to adjust the pH to 7. Under current storage conditions, GONAL-f® RFF Redi-ject® may contain up to 10% of oxidized follitropin alfa."
},
{
"NDCCode": "44087-1116-1",
"PackageDescription": "1 PACKAGE in 1 CARTON (44087-1116-1) / .75 mL in 1 PACKAGE",
"NDC11Code": "44087-1116-01",
"ProductNDC": "44087-1116",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gonal-f Rff Redi-ject",
"NonProprietaryName": "Follitropin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20131016",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA021684",
"LabelerName": "EMD Serono, Inc.",
"SubstanceName": "FOLLITROPIN",
"StrengthNumber": "450",
"StrengthUnit": "[iU]/.75mL",
"Pharm_Classes": "Gonadotropin [EPC], Gonadotropins [CS]",
"Status": "Active",
"LastUpdate": "2025-04-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20131016",
"SamplePackage": "N",
"IndicationAndUsage": "GONAL-f® RFF Redi-ject® is a prefilled gonadotropin-containing auto-injection device indicated for: 1 Induction of ovulation and pregnancy in oligo-anovulatory women in whom the cause of infertility is functional and not due to primary ovarian failure (1.1), 2 Development of multiple follicles in ovulatory women as part of an Assisted Reproductive Technology (ART) cycle (1.2).",
"Description": "Follitropin alfa, a gonadotropin [human follicle stimulating hormone (hFSH)], is a glycoprotein hormone produced by recombinant DNA technology in a Chinese Hamster Ovary (CHO) cell line. It has a dimeric structure consisting of two glycoprotein subunits (alpha and beta). The alpha and beta subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structures are indistinguishable from those of human follicle stimulating hormone. The molecular weight is approximately 31 kDa (14 kDa for alpha subunit and 17 kDa for beta subunit). GONAL-f® RFF Redi-ject® (follitropin alfa) injection is a sterile, clear and colorless to slightly yellow solution in disposable, prefilled single-patient-use pen intended for the subcutaneous use. Each GONAL-f® RFF Redi-ject® pen delivers 300 International Units (22 mcg) follitropin alfa in 0.48 mL and the inactive ingredients: dibasic sodium phosphate (0.43 mg), m-cresol (1.47 mg), methionine (0.05 mg), monobasic sodium phosphate (0.19 mg), poloxamer (0.05 mg), sucrose (29.47 mg) and Water for Injection USP. Phosphoric acid and/or sodium hydroxide may be used to adjust the pH to 7. Each GONAL-f® RFF Redi-ject® pen delivers 450 International Units (33 mcg) follitropin alfa in 0.72 mL and the inactive ingredients: dibasic sodium phosphate (0.65 mg), m-cresol (2.21 mg), methionine (0.07 mg), monobasic sodium phosphate (0.29 mg), poloxamer (0.07 mg), sucrose (44.20 mg) and Water for Injection USP. Phosphoric acid and/or sodium hydroxide may be used to adjust the pH to 7. Each GONAL-f® RFF Redi-ject® pen delivers 900 International Units (66 mcg) follitropin alfa in 1.44 mL and the inactive ingredients: dibasic sodium phosphate (1.3 mg), m-cresol (4.42 mg), methionine (0.15 mg), monobasic sodium phosphate (0.58 mg), poloxamer (0.15 mg), sucrose (88.41 mg) and Water for Injection USP. Phosphoric acid and/or sodium hydroxide may be used to adjust the pH to 7. Under current storage conditions, GONAL-f® RFF Redi-ject® may contain up to 10% of oxidized follitropin alfa."
},
{
"NDCCode": "44087-1117-1",
"PackageDescription": "1 PACKAGE in 1 CARTON (44087-1117-1) / 1.5 mL in 1 PACKAGE",
"NDC11Code": "44087-1117-01",
"ProductNDC": "44087-1117",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gonal-f Rff Redi-ject",
"NonProprietaryName": "Follitropin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20131016",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA021684",
"LabelerName": "EMD Serono, Inc.",
"SubstanceName": "FOLLITROPIN",
"StrengthNumber": "900",
"StrengthUnit": "[iU]/1.5mL",
"Pharm_Classes": "Gonadotropin [EPC], Gonadotropins [CS]",
"Status": "Active",
"LastUpdate": "2025-04-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20131016",
"SamplePackage": "N",
"IndicationAndUsage": "GONAL-f® RFF Redi-ject® is a prefilled gonadotropin-containing auto-injection device indicated for: 1 Induction of ovulation and pregnancy in oligo-anovulatory women in whom the cause of infertility is functional and not due to primary ovarian failure (1.1), 2 Development of multiple follicles in ovulatory women as part of an Assisted Reproductive Technology (ART) cycle (1.2).",
"Description": "Follitropin alfa, a gonadotropin [human follicle stimulating hormone (hFSH)], is a glycoprotein hormone produced by recombinant DNA technology in a Chinese Hamster Ovary (CHO) cell line. It has a dimeric structure consisting of two glycoprotein subunits (alpha and beta). The alpha and beta subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structures are indistinguishable from those of human follicle stimulating hormone. The molecular weight is approximately 31 kDa (14 kDa for alpha subunit and 17 kDa for beta subunit). GONAL-f® RFF Redi-ject® (follitropin alfa) injection is a sterile, clear and colorless to slightly yellow solution in disposable, prefilled single-patient-use pen intended for the subcutaneous use. Each GONAL-f® RFF Redi-ject® pen delivers 300 International Units (22 mcg) follitropin alfa in 0.48 mL and the inactive ingredients: dibasic sodium phosphate (0.43 mg), m-cresol (1.47 mg), methionine (0.05 mg), monobasic sodium phosphate (0.19 mg), poloxamer (0.05 mg), sucrose (29.47 mg) and Water for Injection USP. Phosphoric acid and/or sodium hydroxide may be used to adjust the pH to 7. Each GONAL-f® RFF Redi-ject® pen delivers 450 International Units (33 mcg) follitropin alfa in 0.72 mL and the inactive ingredients: dibasic sodium phosphate (0.65 mg), m-cresol (2.21 mg), methionine (0.07 mg), monobasic sodium phosphate (0.29 mg), poloxamer (0.07 mg), sucrose (44.20 mg) and Water for Injection USP. Phosphoric acid and/or sodium hydroxide may be used to adjust the pH to 7. Each GONAL-f® RFF Redi-ject® pen delivers 900 International Units (66 mcg) follitropin alfa in 1.44 mL and the inactive ingredients: dibasic sodium phosphate (1.3 mg), m-cresol (4.42 mg), methionine (0.15 mg), monobasic sodium phosphate (0.58 mg), poloxamer (0.15 mg), sucrose (88.41 mg) and Water for Injection USP. Phosphoric acid and/or sodium hydroxide may be used to adjust the pH to 7. Under current storage conditions, GONAL-f® RFF Redi-ject® may contain up to 10% of oxidized follitropin alfa."
},
{
"NDCCode": "58103-111-10",
"PackageDescription": "100 kg in 1 DRUM (58103-111-10)",
"NDC11Code": "58103-0111-10",
"ProductNDC": "58103-111",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Calcium Carbonate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20110404",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "SPI Pharma, Inc.",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "58",
"StrengthUnit": "kg/100kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "78206-129-59",
"PackageDescription": "1 KIT in 1 CARTON (78206-129-59) / 1 CARTRIDGE in 1 KIT / .36 mL in 1 CARTRIDGE (78206-129-58) ",
"NDC11Code": "78206-0129-59",
"ProductNDC": "78206-129",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Follistim Aq",
"NonProprietaryName": "Follitropin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20230724",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA021211",
"LabelerName": "Organon LLC",
"SubstanceName": "FOLLITROPIN",
"StrengthNumber": "300",
"StrengthUnit": "[iU]/.36mL",
"Pharm_Classes": "Gonadotropin [EPC], Gonadotropins [CS]",
"Status": "Active",
"LastUpdate": "2026-05-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230724",
"SamplePackage": "Y",
"IndicationAndUsage": "FOLLISTIM® AQ Cartridge (follitropin beta) injection, is indicated. In Women for.",
"Description": "Follitropin beta, a gonadotropin [human follicle-stimulating hormone (hFSH)], is a glycoprotein hormone produced by recombinant DNA technology in a Chinese hamster ovary (CHO) cell line. It has a dimeric structure containing two glycoprotein subunits (alpha and beta). The alpha and beta subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structures are indistinguishable from that of hFSH. The molecular weight is approximately 40 kDa. FOLLISTIM AQ Cartridge (follitropin beta) injection is a sterile clear and colorless solution, containing either 300 International Units, 600 International Units, or 900 International Units of follitropin beta in disposable single-patient-use cartridges for subcutaneous use only with the FOLLISTIM Pen. Each cartridge delivers 300 International Units in 0.36 mL and the inactive ingredients: benzyl alcohol (3.6 mg; preservative), methionine (0.18 mg), polysorbate 20 (0.072 mg), sodium citrate (4.64 mg), sucrose (18 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 600 International Units in 0.72 mL and the inactive ingredients: benzyl alcohol (7.2 mg; preservative), methionine (0.36 mg), polysorbate 20 (0.144 mg), sodium citrate (9.3 mg), sucrose (36 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 900 International Units in 1.08 mL and the inactive ingredients: benzyl alcohol (10.8 mg; preservative), methionine (0.54 mg), polysorbate 20 (0.216 mg), sodium citrate (13.9 mg), sucrose (54 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Under current storage conditions, FOLLISTIM AQ may contain up to 11% of oxidized follitropin beta."
},
{
"NDCCode": "78206-130-59",
"PackageDescription": "1 KIT in 1 CARTON (78206-130-59) / 1 CARTRIDGE in 1 KIT / .72 mL in 1 CARTRIDGE (78206-130-58) ",
"NDC11Code": "78206-0130-59",
"ProductNDC": "78206-130",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Follistim Aq",
"NonProprietaryName": "Follitropin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20230724",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA021211",
"LabelerName": "Organon LLC",
"SubstanceName": "FOLLITROPIN",
"StrengthNumber": "600",
"StrengthUnit": "[iU]/.72mL",
"Pharm_Classes": "Gonadotropin [EPC], Gonadotropins [CS]",
"Status": "Active",
"LastUpdate": "2026-05-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230724",
"SamplePackage": "Y",
"IndicationAndUsage": "FOLLISTIM® AQ Cartridge (follitropin beta) injection, is indicated. In Women for.",
"Description": "Follitropin beta, a gonadotropin [human follicle-stimulating hormone (hFSH)], is a glycoprotein hormone produced by recombinant DNA technology in a Chinese hamster ovary (CHO) cell line. It has a dimeric structure containing two glycoprotein subunits (alpha and beta). The alpha and beta subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structures are indistinguishable from that of hFSH. The molecular weight is approximately 40 kDa. FOLLISTIM AQ Cartridge (follitropin beta) injection is a sterile clear and colorless solution, containing either 300 International Units, 600 International Units, or 900 International Units of follitropin beta in disposable single-patient-use cartridges for subcutaneous use only with the FOLLISTIM Pen. Each cartridge delivers 300 International Units in 0.36 mL and the inactive ingredients: benzyl alcohol (3.6 mg; preservative), methionine (0.18 mg), polysorbate 20 (0.072 mg), sodium citrate (4.64 mg), sucrose (18 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 600 International Units in 0.72 mL and the inactive ingredients: benzyl alcohol (7.2 mg; preservative), methionine (0.36 mg), polysorbate 20 (0.144 mg), sodium citrate (9.3 mg), sucrose (36 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 900 International Units in 1.08 mL and the inactive ingredients: benzyl alcohol (10.8 mg; preservative), methionine (0.54 mg), polysorbate 20 (0.216 mg), sodium citrate (13.9 mg), sucrose (54 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Under current storage conditions, FOLLISTIM AQ may contain up to 11% of oxidized follitropin beta."
},
{
"NDCCode": "0019-9050-40",
"PackageDescription": "1 KIT in 1 BOX (0019-9050-40) * 1 mL in 1 VIAL, GLASS * 1 mL in 1 VIAL, GLASS",
"NDC11Code": "00019-9050-40",
"ProductNDC": "0019-9050",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Octreoscan",
"NonProprietaryName": "Indium In -111 Pentetreotide",
"DosageFormName": "KIT",
"StartMarketingDate": "20070501",
"EndMarketingDate": "20170701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020314",
"LabelerName": "Mallinckrodt Inc.",
"Status": "Deprecated",
"LastUpdate": "2017-07-03"
},
{
"NDCCode": "0019-9132-06",
"PackageDescription": "1 VIAL, GLASS in 1 CAN (0019-9132-06) > .5 mL in 1 VIAL, GLASS",
"NDC11Code": "00019-9132-06",
"ProductNDC": "0019-9132",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Indium In 111 Chloride",
"NonProprietaryName": "Indium In 111 Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20071207",
"EndMarketingDate": "20170701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019841",
"LabelerName": "Mallinckrodt Inc.",
"SubstanceName": "INDIUM CHLORIDE IN-111",
"StrengthNumber": "10",
"StrengthUnit": "mCi/mL",
"Status": "Deprecated",
"LastUpdate": "2017-07-03"
},
{
"NDCCode": "0025-2818-31",
"PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0025-2818-31) ",
"NDC11Code": "00025-2818-31",
"ProductNDC": "0025-2818",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Calan Sr",
"NonProprietaryName": "Verapamil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20201216",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019152",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "VERAPAMIL HYDROCHLORIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-03-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20201216",
"SamplePackage": "N",
"IndicationAndUsage": "CALAN SR is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.",
"Description": "CALAN SR (verapamil hydrochloride) is a calcium ion influx inhibitor (slow-channel blocker or calcium ion antagonist). CALAN SR is available for oral administration as light green, capsule-shaped, scored, film-coated tablets containing 240 mg of verapamil hydrochloride (equivalent to 222.16 mg verapamil free base); as light pink, oval, scored, film-coated tablets containing 180 mg of verapamil hydrochloride (equivalent to 166.62 mg verapamil free base); and as light violet, oval, film-coated tablets containing 120 mg of verapamil hydrochloride (equivalent to 111.08 mg verapamil free base). The tablets are designed for extended-release of the drug in the gastrointestinal tract; extended-release characteristics are not altered when the tablet is divided in half. The structural formula of verapamil HCl is. Verapamil HCl is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, chloroform, and methanol. Verapamil HCl is not chemically related to other cardioactive drugs. Inactive ingredients include alginate, carnauba wax, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl pyrrolidone, talc, titanium dioxide, and coloring agents: 240 mg—D&C Yellow No. 10 Lake and FD&C Blue No. 2 Lake; 120 and 180 mg—iron oxide."
},
{
"NDCCode": "0049-0050-01",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (0049-0050-01) / 60 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "00049-0050-01",
"ProductNDC": "0049-0050",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zoloft",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "SOLUTION, CONCENTRATE",
"RouteName": "ORAL",
"StartMarketingDate": "20170106",
"EndMarketingDate": "20260630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020990",
"LabelerName": "ROERIG",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170106",
"EndMarketingDatePackage": "20260630",
"SamplePackage": "N",
"IndicationAndUsage": "ZOLOFT is indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).",
"Description": "ZOLOFT contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S‑cis)‑4‑(3,4‑dichlorophenyl)‑1,2,3,4‑tetrahydro-N‑methyl‑1‑naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. ZOLOFT tablets for oral administration contain 28.0 mg, 56.0 mg and 111.9 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, D & C Yellow #10 aluminum lake (in 25 mg tablet), FD & C Blue #1 aluminum lake (in 25 mg tablet), FD & C Red #40 aluminum lake (in 25 mg tablet), FD & C Blue #2 aluminum lake (in 50 mg tablet), hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, synthetic yellow iron oxide (in 100 mg tablet), and titanium dioxide. ZOLOFT oral solution is available in a multidose 60 mL bottle. Each mL of solution contains 22.4 mg sertraline hydrochloride equivalent to 20 mg of sertraline. The solution contains the following inactive ingredients: glycerin, alcohol (12%), menthol, butylated hydroxytoluene (BHT). The oral solution must be diluted prior to administration [See Dosage and Administration (2.7)]. The dispenser contains dry natural rubber."
},
{
"NDCCode": "0049-4900-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0049-4900-30) ",
"NDC11Code": "00049-4900-30",
"ProductNDC": "0049-4900",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zoloft",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19920211",
"EndMarketingDate": "20260630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019839",
"LabelerName": "ROERIG",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19920211",
"EndMarketingDatePackage": "20260630",
"SamplePackage": "N",
"IndicationAndUsage": "ZOLOFT is indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).",
"Description": "ZOLOFT contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S‑cis)‑4‑(3,4‑dichlorophenyl)‑1,2,3,4‑tetrahydro-N‑methyl‑1‑naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. ZOLOFT tablets for oral administration contain 28.0 mg, 56.0 mg and 111.9 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, D & C Yellow #10 aluminum lake (in 25 mg tablet), FD & C Blue #1 aluminum lake (in 25 mg tablet), FD & C Red #40 aluminum lake (in 25 mg tablet), FD & C Blue #2 aluminum lake (in 50 mg tablet), hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, synthetic yellow iron oxide (in 100 mg tablet), and titanium dioxide. ZOLOFT oral solution is available in a multidose 60 mL bottle. Each mL of solution contains 22.4 mg sertraline hydrochloride equivalent to 20 mg of sertraline. The solution contains the following inactive ingredients: glycerin, alcohol (12%), menthol, butylated hydroxytoluene (BHT). The oral solution must be diluted prior to administration [See Dosage and Administration (2.7)]. The dispenser contains dry natural rubber."
},
{
"NDCCode": "0049-4900-41",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (0049-4900-41) / 1 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00049-4900-41",
"ProductNDC": "0049-4900",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zoloft",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19920211",
"EndMarketingDate": "20260630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019839",
"LabelerName": "ROERIG",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19920211",
"EndMarketingDatePackage": "20260630",
"SamplePackage": "N",
"IndicationAndUsage": "ZOLOFT is indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).",
"Description": "ZOLOFT contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S‑cis)‑4‑(3,4‑dichlorophenyl)‑1,2,3,4‑tetrahydro-N‑methyl‑1‑naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. ZOLOFT tablets for oral administration contain 28.0 mg, 56.0 mg and 111.9 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, D & C Yellow #10 aluminum lake (in 25 mg tablet), FD & C Blue #1 aluminum lake (in 25 mg tablet), FD & C Red #40 aluminum lake (in 25 mg tablet), FD & C Blue #2 aluminum lake (in 50 mg tablet), hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, synthetic yellow iron oxide (in 100 mg tablet), and titanium dioxide. ZOLOFT oral solution is available in a multidose 60 mL bottle. Each mL of solution contains 22.4 mg sertraline hydrochloride equivalent to 20 mg of sertraline. The solution contains the following inactive ingredients: glycerin, alcohol (12%), menthol, butylated hydroxytoluene (BHT). The oral solution must be diluted prior to administration [See Dosage and Administration (2.7)]. The dispenser contains dry natural rubber."
},
{
"NDCCode": "0049-4910-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0049-4910-30) ",
"NDC11Code": "00049-4910-30",
"ProductNDC": "0049-4910",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zoloft",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19920211",
"EndMarketingDate": "20260630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019839",
"LabelerName": "ROERIG",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19920211",
"EndMarketingDatePackage": "20260630",
"SamplePackage": "N",
"IndicationAndUsage": "ZOLOFT is indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).",
"Description": "ZOLOFT contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S‑cis)‑4‑(3,4‑dichlorophenyl)‑1,2,3,4‑tetrahydro-N‑methyl‑1‑naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. ZOLOFT tablets for oral administration contain 28.0 mg, 56.0 mg and 111.9 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, D & C Yellow #10 aluminum lake (in 25 mg tablet), FD & C Blue #1 aluminum lake (in 25 mg tablet), FD & C Red #40 aluminum lake (in 25 mg tablet), FD & C Blue #2 aluminum lake (in 50 mg tablet), hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, synthetic yellow iron oxide (in 100 mg tablet), and titanium dioxide. ZOLOFT oral solution is available in a multidose 60 mL bottle. Each mL of solution contains 22.4 mg sertraline hydrochloride equivalent to 20 mg of sertraline. The solution contains the following inactive ingredients: glycerin, alcohol (12%), menthol, butylated hydroxytoluene (BHT). The oral solution must be diluted prior to administration [See Dosage and Administration (2.7)]. The dispenser contains dry natural rubber."
},
{
"NDCCode": "0049-4910-41",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (0049-4910-41) / 1 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00049-4910-41",
"ProductNDC": "0049-4910",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zoloft",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19920211",
"EndMarketingDate": "20260630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019839",
"LabelerName": "ROERIG",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19920211",
"EndMarketingDatePackage": "20260630",
"SamplePackage": "N",
"IndicationAndUsage": "ZOLOFT is indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).",
"Description": "ZOLOFT contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S‑cis)‑4‑(3,4‑dichlorophenyl)‑1,2,3,4‑tetrahydro-N‑methyl‑1‑naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. ZOLOFT tablets for oral administration contain 28.0 mg, 56.0 mg and 111.9 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, D & C Yellow #10 aluminum lake (in 25 mg tablet), FD & C Blue #1 aluminum lake (in 25 mg tablet), FD & C Red #40 aluminum lake (in 25 mg tablet), FD & C Blue #2 aluminum lake (in 50 mg tablet), hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, synthetic yellow iron oxide (in 100 mg tablet), and titanium dioxide. ZOLOFT oral solution is available in a multidose 60 mL bottle. Each mL of solution contains 22.4 mg sertraline hydrochloride equivalent to 20 mg of sertraline. The solution contains the following inactive ingredients: glycerin, alcohol (12%), menthol, butylated hydroxytoluene (BHT). The oral solution must be diluted prior to administration [See Dosage and Administration (2.7)]. The dispenser contains dry natural rubber."
},
{
"NDCCode": "0049-4960-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0049-4960-30) ",
"NDC11Code": "00049-4960-30",
"ProductNDC": "0049-4960",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zoloft",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19920211",
"EndMarketingDate": "20251031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019839",
"LabelerName": "ROERIG",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19920211",
"EndMarketingDatePackage": "20251031",
"SamplePackage": "N",
"IndicationAndUsage": "ZOLOFT is indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).",
"Description": "ZOLOFT contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S‑cis)‑4‑(3,4‑dichlorophenyl)‑1,2,3,4‑tetrahydro-N‑methyl‑1‑naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. ZOLOFT tablets for oral administration contain 28.0 mg, 56.0 mg and 111.9 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, D & C Yellow #10 aluminum lake (in 25 mg tablet), FD & C Blue #1 aluminum lake (in 25 mg tablet), FD & C Red #40 aluminum lake (in 25 mg tablet), FD & C Blue #2 aluminum lake (in 50 mg tablet), hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, synthetic yellow iron oxide (in 100 mg tablet), and titanium dioxide. ZOLOFT oral solution is available in a multidose 60 mL bottle. Each mL of solution contains 22.4 mg sertraline hydrochloride equivalent to 20 mg of sertraline. The solution contains the following inactive ingredients: glycerin, alcohol (12%), menthol, butylated hydroxytoluene (BHT). The oral solution must be diluted prior to administration [See Dosage and Administration (2.7)]. The dispenser contains dry natural rubber."
},
{
"NDCCode": "0052-0313-01",
"PackageDescription": "1 KIT in 1 CARTON (0052-0313-01) / 1 CARTRIDGE in 1 KIT / .42 mL in 1 CARTRIDGE",
"NDC11Code": "00052-0313-01",
"ProductNDC": "0052-0313",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Follistim Aq",
"NonProprietaryName": "Follitropin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20040324",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA021211",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "FOLLITROPIN",
"StrengthNumber": "350",
"StrengthUnit": "[iU]/.42mL",
"Pharm_Classes": "Gonadotropin [EPC], Gonadotropins [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20040324",
"SamplePackage": "N",
"IndicationAndUsage": "Follistim® AQ Cartridge (follitropin beta) injection, is indicated. In Women for.",
"Description": "Follitropin beta, a gonadotropin [human follicle-stimulating hormone (hFSH)], is a glycoprotein hormone produced by recombinant DNA technology in a Chinese hamster ovary (CHO) cell line. It has a dimeric structure containing two glycoprotein subunits (alpha and beta). The alpha and beta subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structures are indistinguishable from that of hFSH. The molecular weight is approximately 40 kDa. Follistim AQ Cartridge (follitropin beta) injection is a sterile clear and colorless solution, containing either 300 International Units, 600 International Units, or 900 International Units of follitropin beta in disposable single-patient-use cartridges for subcutaneous use only with the Follistim Pen. Each cartridge delivers 300 International Units in 0.36 mL and the inactive ingredients: benzyl alcohol (3.6 mg; preservative), methionine (0.18 mg), polysorbate 20 (0.072 mg), sodium citrate (4.64 mg), sucrose (18 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 600 International Units in 0.72 mL and the inactive ingredients: benzyl alcohol (7.2 mg; preservative), methionine (0.36 mg), polysorbate 20 (0.144 mg), sodium citrate (9.3 mg), sucrose (36 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 900 International Units in 1.08 mL and the inactive ingredients: benzyl alcohol (10.8 mg; preservative), methionine (0.54 mg), polysorbate 20 (0.216 mg), sodium citrate (13.9 mg), sucrose (54 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Under current storage conditions, Follistim AQ may contain up to 11% of oxidized follitropin beta."
},
{
"NDCCode": "0052-0313-81",
"PackageDescription": "1 KIT in 1 CARTON (0052-0313-81) / 1 CARTRIDGE in 1 KIT / .42 mL in 1 CARTRIDGE",
"NDC11Code": "00052-0313-81",
"ProductNDC": "0052-0313",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Follistim Aq",
"NonProprietaryName": "Follitropin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20040324",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA021211",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "FOLLITROPIN",
"StrengthNumber": "350",
"StrengthUnit": "[iU]/.42mL",
"Pharm_Classes": "Gonadotropin [EPC], Gonadotropins [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20040324",
"SamplePackage": "N",
"IndicationAndUsage": "Follistim® AQ Cartridge (follitropin beta) injection, is indicated. In Women for.",
"Description": "Follitropin beta, a gonadotropin [human follicle-stimulating hormone (hFSH)], is a glycoprotein hormone produced by recombinant DNA technology in a Chinese hamster ovary (CHO) cell line. It has a dimeric structure containing two glycoprotein subunits (alpha and beta). The alpha and beta subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structures are indistinguishable from that of hFSH. The molecular weight is approximately 40 kDa. Follistim AQ Cartridge (follitropin beta) injection is a sterile clear and colorless solution, containing either 300 International Units, 600 International Units, or 900 International Units of follitropin beta in disposable single-patient-use cartridges for subcutaneous use only with the Follistim Pen. Each cartridge delivers 300 International Units in 0.36 mL and the inactive ingredients: benzyl alcohol (3.6 mg; preservative), methionine (0.18 mg), polysorbate 20 (0.072 mg), sodium citrate (4.64 mg), sucrose (18 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 600 International Units in 0.72 mL and the inactive ingredients: benzyl alcohol (7.2 mg; preservative), methionine (0.36 mg), polysorbate 20 (0.144 mg), sodium citrate (9.3 mg), sucrose (36 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 900 International Units in 1.08 mL and the inactive ingredients: benzyl alcohol (10.8 mg; preservative), methionine (0.54 mg), polysorbate 20 (0.216 mg), sodium citrate (13.9 mg), sucrose (54 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Under current storage conditions, Follistim AQ may contain up to 11% of oxidized follitropin beta."
},
{
"NDCCode": "0052-0316-01",
"PackageDescription": "1 KIT in 1 CARTON (0052-0316-01) / 1 CARTRIDGE in 1 KIT / .78 mL in 1 CARTRIDGE",
"NDC11Code": "00052-0316-01",
"ProductNDC": "0052-0316",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Follistim Aq",
"NonProprietaryName": "Follitropin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20040324",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA021211",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "FOLLITROPIN",
"StrengthNumber": "650",
"StrengthUnit": "[iU]/.78mL",
"Pharm_Classes": "Gonadotropin [EPC], Gonadotropins [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20040324",
"SamplePackage": "N",
"IndicationAndUsage": "Follistim® AQ Cartridge (follitropin beta) injection, is indicated. In Women for.",
"Description": "Follitropin beta, a gonadotropin [human follicle-stimulating hormone (hFSH)], is a glycoprotein hormone produced by recombinant DNA technology in a Chinese hamster ovary (CHO) cell line. It has a dimeric structure containing two glycoprotein subunits (alpha and beta). The alpha and beta subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structures are indistinguishable from that of hFSH. The molecular weight is approximately 40 kDa. Follistim AQ Cartridge (follitropin beta) injection is a sterile clear and colorless solution, containing either 300 International Units, 600 International Units, or 900 International Units of follitropin beta in disposable single-patient-use cartridges for subcutaneous use only with the Follistim Pen. Each cartridge delivers 300 International Units in 0.36 mL and the inactive ingredients: benzyl alcohol (3.6 mg; preservative), methionine (0.18 mg), polysorbate 20 (0.072 mg), sodium citrate (4.64 mg), sucrose (18 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 600 International Units in 0.72 mL and the inactive ingredients: benzyl alcohol (7.2 mg; preservative), methionine (0.36 mg), polysorbate 20 (0.144 mg), sodium citrate (9.3 mg), sucrose (36 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 900 International Units in 1.08 mL and the inactive ingredients: benzyl alcohol (10.8 mg; preservative), methionine (0.54 mg), polysorbate 20 (0.216 mg), sodium citrate (13.9 mg), sucrose (54 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Under current storage conditions, Follistim AQ may contain up to 11% of oxidized follitropin beta."
},
{
"NDCCode": "0052-0316-81",
"PackageDescription": "1 KIT in 1 CARTON (0052-0316-81) / 1 CARTRIDGE in 1 KIT / .78 mL in 1 CARTRIDGE",
"NDC11Code": "00052-0316-81",
"ProductNDC": "0052-0316",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Follistim Aq",
"NonProprietaryName": "Follitropin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20040324",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA021211",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "FOLLITROPIN",
"StrengthNumber": "650",
"StrengthUnit": "[iU]/.78mL",
"Pharm_Classes": "Gonadotropin [EPC], Gonadotropins [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20040324",
"SamplePackage": "N",
"IndicationAndUsage": "Follistim® AQ Cartridge (follitropin beta) injection, is indicated. In Women for.",
"Description": "Follitropin beta, a gonadotropin [human follicle-stimulating hormone (hFSH)], is a glycoprotein hormone produced by recombinant DNA technology in a Chinese hamster ovary (CHO) cell line. It has a dimeric structure containing two glycoprotein subunits (alpha and beta). The alpha and beta subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structures are indistinguishable from that of hFSH. The molecular weight is approximately 40 kDa. Follistim AQ Cartridge (follitropin beta) injection is a sterile clear and colorless solution, containing either 300 International Units, 600 International Units, or 900 International Units of follitropin beta in disposable single-patient-use cartridges for subcutaneous use only with the Follistim Pen. Each cartridge delivers 300 International Units in 0.36 mL and the inactive ingredients: benzyl alcohol (3.6 mg; preservative), methionine (0.18 mg), polysorbate 20 (0.072 mg), sodium citrate (4.64 mg), sucrose (18 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 600 International Units in 0.72 mL and the inactive ingredients: benzyl alcohol (7.2 mg; preservative), methionine (0.36 mg), polysorbate 20 (0.144 mg), sodium citrate (9.3 mg), sucrose (36 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 900 International Units in 1.08 mL and the inactive ingredients: benzyl alcohol (10.8 mg; preservative), methionine (0.54 mg), polysorbate 20 (0.216 mg), sodium citrate (13.9 mg), sucrose (54 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Under current storage conditions, Follistim AQ may contain up to 11% of oxidized follitropin beta."
},
{
"NDCCode": "0052-0326-01",
"PackageDescription": "1 KIT in 1 CARTON (0052-0326-01) / 1 CARTRIDGE in 1 KIT / 1.17 mL in 1 CARTRIDGE",
"NDC11Code": "00052-0326-01",
"ProductNDC": "0052-0326",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Follistim Aq",
"NonProprietaryName": "Follitropin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20040324",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA021211",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "FOLLITROPIN",
"StrengthNumber": "975",
"StrengthUnit": "[iU]/1.17mL",
"Pharm_Classes": "Gonadotropin [EPC], Gonadotropins [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20040324",
"SamplePackage": "N",
"IndicationAndUsage": "Follistim® AQ Cartridge (follitropin beta) injection, is indicated. In Women for.",
"Description": "Follitropin beta, a gonadotropin [human follicle-stimulating hormone (hFSH)], is a glycoprotein hormone produced by recombinant DNA technology in a Chinese hamster ovary (CHO) cell line. It has a dimeric structure containing two glycoprotein subunits (alpha and beta). The alpha and beta subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structures are indistinguishable from that of hFSH. The molecular weight is approximately 40 kDa. Follistim AQ Cartridge (follitropin beta) injection is a sterile clear and colorless solution, containing either 300 International Units, 600 International Units, or 900 International Units of follitropin beta in disposable single-patient-use cartridges for subcutaneous use only with the Follistim Pen. Each cartridge delivers 300 International Units in 0.36 mL and the inactive ingredients: benzyl alcohol (3.6 mg; preservative), methionine (0.18 mg), polysorbate 20 (0.072 mg), sodium citrate (4.64 mg), sucrose (18 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 600 International Units in 0.72 mL and the inactive ingredients: benzyl alcohol (7.2 mg; preservative), methionine (0.36 mg), polysorbate 20 (0.144 mg), sodium citrate (9.3 mg), sucrose (36 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 900 International Units in 1.08 mL and the inactive ingredients: benzyl alcohol (10.8 mg; preservative), methionine (0.54 mg), polysorbate 20 (0.216 mg), sodium citrate (13.9 mg), sucrose (54 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Under current storage conditions, Follistim AQ may contain up to 11% of oxidized follitropin beta."
},
{
"NDCCode": "0093-3560-26",
"PackageDescription": "2 CARTON in 1 CARTON (0093-3560-26) / 1 KIT in 1 CARTON (0093-3560-19) * 1 L in 1 POUCH (0093-9043-19) * 1 L in 1 POUCH * 1 L in 1 POUCH (0093-9044-19) ",
"NDC11Code": "00093-3560-26",
"ProductNDC": "0093-3560",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Peg-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate And Ascorbic Acid",
"NonProprietaryName": "Peg-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate And Ascorbic Acid",
"DosageFormName": "KIT",
"StartMarketingDate": "20200831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090145",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"Status": "Active",
"LastUpdate": "2023-02-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200831",
"SamplePackage": "N",
"IndicationAndUsage": "PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults.",
"Description": "PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution is an osmotic laxative consisting of 6 pouches (2 of Pouch A, 2 of Pouch B and 2 of Lemon Flavor Pack) containing white to yellow free flowing powder with odor of lemon for reconstitution. Each Pouch A contains 100 grams of polyethylene glycol (PEG) 3350, NF, 7.5 grams of sodium sulfate, USP, 2.691 grams of sodium chloride, USP, and 1.015 grams of potassium chloride, USP. Pouch A contains 111.2 g of powder for oral solution. Each Pouch B contains 4.7 grams of ascorbic acid, USP and 5.9 grams of sodium ascorbate, USP. Pouch B contains 10.6 g of powder for oral solution. Each Lemon Flavor pack contains natural lemon flavor; maltodextrin and saccharin sodium. When 1 Pouch A, 1 Pouch B and 1 Lemon Flavor pack are dissolved together in water to a volume of 1 liter, PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution is an oral solution having a lemon taste. The entire, reconstituted, 2-liter PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution colon preparation contains 200 grams of PEG-3350, 15 grams of sodium sulfate, 5.38 grams of sodium chloride, 2.03 grams of potassium chloride, 9.4 grams of ascorbic acid, and 11.8 grams of sodium ascorbate plus the following excipients: sodium saccharin, USP, maltodextrin, NF, and lemon flavoring. A mixing container for reconstitution is enclosed."
},
{
"NDCCode": "0316-2062-30",
"PackageDescription": "89 mL in 1 TUBE (0316-2062-30) ",
"NDC11Code": "00316-2062-30",
"ProductNDC": "0316-2062",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Blue Lizard Kids Spf 50 Sunscreen",
"NonProprietaryName": "Octisalate And Titanium Dioxide And Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210209",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Crown Laboratories",
"SubstanceName": "ZINC OXIDE; TITANIUM DIOXIDE; OCTISALATE",
"StrengthNumber": "111; 59.5; 55.5",
"StrengthUnit": "mg/mL; mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210501",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn and photodamage caused by UVA/UVB exposure. Higher SPF gives more sunburn protection. If used as directed with other sun protection measures (see Directions), decreases the risks of skin cancer and early skin aging caused by the sun ."
},
{
"NDCCode": "0316-2062-40",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (0316-2062-40) / 148 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "00316-2062-40",
"ProductNDC": "0316-2062",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Blue Lizard Kids Spf 50 Sunscreen",
"NonProprietaryName": "Octisalate And Titanium Dioxide And Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210209",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Crown Laboratories",
"SubstanceName": "OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "55.5; 59.5; 111",
"StrengthUnit": "mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210501",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn and photodamage caused by UVA/UVB exposure. Higher SPF gives more sunburn protection. If used as directed with other sun protection measures (see Directions), decreases the risks of skin cancer and early skin aging caused by the sun ."
},
{
"NDCCode": "0316-2062-45",
"PackageDescription": "148 mL in 1 TUBE (0316-2062-45) ",
"NDC11Code": "00316-2062-45",
"ProductNDC": "0316-2062",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Blue Lizard Kids Spf 50 Sunscreen",
"NonProprietaryName": "Octisalate And Titanium Dioxide And Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210209",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Crown Laboratories",
"SubstanceName": "ZINC OXIDE; TITANIUM DIOXIDE; OCTISALATE",
"StrengthNumber": "111; 59.5; 55.5",
"StrengthUnit": "mg/mL; mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210209",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn and photodamage caused by UVA/UVB exposure. Higher SPF gives more sunburn protection. If used as directed with other sun protection measures (see Directions), decreases the risks of skin cancer and early skin aging caused by the sun ."
},
{
"NDCCode": "0316-2062-50",
"PackageDescription": "259 mL in 1 BOTTLE, PLASTIC (0316-2062-50) ",
"NDC11Code": "00316-2062-50",
"ProductNDC": "0316-2062",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Blue Lizard Kids Spf 50 Sunscreen",
"NonProprietaryName": "Octisalate And Titanium Dioxide And Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210209",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Crown Laboratories",
"SubstanceName": "OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "55.5; 59.5; 111",
"StrengthUnit": "mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210501",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn and photodamage caused by UVA/UVB exposure. Higher SPF gives more sunburn protection. If used as directed with other sun protection measures (see Directions), decreases the risks of skin cancer and early skin aging caused by the sun ."
},
{
"NDCCode": "0316-2072-30",
"PackageDescription": "89 mL in 1 TUBE (0316-2072-30) ",
"NDC11Code": "00316-2072-30",
"ProductNDC": "0316-2072",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Blue Lizard Active Spf 50 Sunscreen",
"NonProprietaryName": "Octisalate And Titanium Dioxide And Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210209",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Crown Laboratories",
"SubstanceName": "OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "55.5; 59.5; 111",
"StrengthUnit": "mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210501",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn and photodamage caused by UVA/UVB exposure. Higher SPF gives more sunburn protection. If used as directed with other sun protection measures (see Directions), decreases the risks of skin cancer and early skin aging caused by the sun ."
},
{
"NDCCode": "0316-2072-40",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (0316-2072-40) / 148 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "00316-2072-40",
"ProductNDC": "0316-2072",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Blue Lizard Active Spf 50 Sunscreen",
"NonProprietaryName": "Octisalate And Titanium Dioxide And Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210209",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Crown Laboratories",
"SubstanceName": "OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "55.5; 59.5; 111",
"StrengthUnit": "mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210224",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn and photodamage caused by UVA/UVB exposure. Higher SPF gives more sunburn protection. If used as directed with other sun protection measures (see Directions), decreases the risks of skin cancer and early skin aging caused by the sun ."
},
{
"NDCCode": "0316-2072-45",
"PackageDescription": "148 mL in 1 TUBE (0316-2072-45) ",
"NDC11Code": "00316-2072-45",
"ProductNDC": "0316-2072",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Blue Lizard Active Spf 50 Sunscreen",
"NonProprietaryName": "Octisalate And Titanium Dioxide And Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210209",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Crown Laboratories",
"SubstanceName": "OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "55.5; 59.5; 111",
"StrengthUnit": "mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210209",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn and photodamage caused by UVA/UVB exposure. Higher SPF gives more sunburn protection. If used as directed with other sun protection measures (see Directions), decreases the risks of skin cancer and early skin aging caused by the sun ."
},
{
"NDCCode": "0316-2072-50",
"PackageDescription": "259 mL in 1 BOTTLE, PLASTIC (0316-2072-50) ",
"NDC11Code": "00316-2072-50",
"ProductNDC": "0316-2072",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Blue Lizard Active Spf 50 Sunscreen",
"NonProprietaryName": "Octisalate And Titanium Dioxide And Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210209",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Crown Laboratories",
"SubstanceName": "OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "55.5; 59.5; 111",
"StrengthUnit": "mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210501",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn and photodamage caused by UVA/UVB exposure. Higher SPF gives more sunburn protection. If used as directed with other sun protection measures (see Directions), decreases the risks of skin cancer and early skin aging caused by the sun ."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>50320-111-58</NDCCode>
<PackageDescription>500 mL in 1 CANISTER (50320-111-58)</PackageDescription>
<NDC11Code>50320-0111-58</NDC11Code>
<ProductNDC>50320-111</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Monk</ProprietaryName>
<ProprietaryNameSuffix>Hand Sanitizing Wipes</ProprietaryNameSuffix>
<NonProprietaryName>Benzethonium Chloride</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100106</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333</ApplicationNumber>
<LabelerName>National Towelette Company</LabelerName>
<SubstanceName>BENZETHONIUM CHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mL/1000mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>44087-1115-1</NDCCode>
<PackageDescription>1 PACKAGE in 1 CARTON (44087-1115-1) / .5 mL in 1 PACKAGE</PackageDescription>
<NDC11Code>44087-1115-01</NDC11Code>
<ProductNDC>44087-1115</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gonal-f Rff Redi-ject</ProprietaryName>
<NonProprietaryName>Follitropin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20131016</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA021684</ApplicationNumber>
<LabelerName>EMD Serono, Inc.</LabelerName>
<SubstanceName>FOLLITROPIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>[iU]/.5mL</StrengthUnit>
<Pharm_Classes>Gonadotropin [EPC], Gonadotropins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131016</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GONAL-f® RFF Redi-ject® is a prefilled gonadotropin-containing auto-injection device indicated for: 1 Induction of ovulation and pregnancy in oligo-anovulatory women in whom the cause of infertility is functional and not due to primary ovarian failure (1.1), 2 Development of multiple follicles in ovulatory women as part of an Assisted Reproductive Technology (ART) cycle (1.2).</IndicationAndUsage>
<Description>Follitropin alfa, a gonadotropin [human follicle stimulating hormone (hFSH)], is a glycoprotein hormone produced by recombinant DNA technology in a Chinese Hamster Ovary (CHO) cell line. It has a dimeric structure consisting of two glycoprotein subunits (alpha and beta). The alpha and beta subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structures are indistinguishable from those of human follicle stimulating hormone. The molecular weight is approximately 31 kDa (14 kDa for alpha subunit and 17 kDa for beta subunit). GONAL-f® RFF Redi-ject® (follitropin alfa) injection is a sterile, clear and colorless to slightly yellow solution in disposable, prefilled single-patient-use pen intended for the subcutaneous use. Each GONAL-f® RFF Redi-ject® pen delivers 300 International Units (22 mcg) follitropin alfa in 0.48 mL and the inactive ingredients: dibasic sodium phosphate (0.43 mg), m-cresol (1.47 mg), methionine (0.05 mg), monobasic sodium phosphate (0.19 mg), poloxamer (0.05 mg), sucrose (29.47 mg) and Water for Injection USP. Phosphoric acid and/or sodium hydroxide may be used to adjust the pH to 7. Each GONAL-f® RFF Redi-ject® pen delivers 450 International Units (33 mcg) follitropin alfa in 0.72 mL and the inactive ingredients: dibasic sodium phosphate (0.65 mg), m-cresol (2.21 mg), methionine (0.07 mg), monobasic sodium phosphate (0.29 mg), poloxamer (0.07 mg), sucrose (44.20 mg) and Water for Injection USP. Phosphoric acid and/or sodium hydroxide may be used to adjust the pH to 7. Each GONAL-f® RFF Redi-ject® pen delivers 900 International Units (66 mcg) follitropin alfa in 1.44 mL and the inactive ingredients: dibasic sodium phosphate (1.3 mg), m-cresol (4.42 mg), methionine (0.15 mg), monobasic sodium phosphate (0.58 mg), poloxamer (0.15 mg), sucrose (88.41 mg) and Water for Injection USP. Phosphoric acid and/or sodium hydroxide may be used to adjust the pH to 7. Under current storage conditions, GONAL-f® RFF Redi-ject® may contain up to 10% of oxidized follitropin alfa.</Description>
</NDC>
<NDC>
<NDCCode>44087-1116-1</NDCCode>
<PackageDescription>1 PACKAGE in 1 CARTON (44087-1116-1) / .75 mL in 1 PACKAGE</PackageDescription>
<NDC11Code>44087-1116-01</NDC11Code>
<ProductNDC>44087-1116</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gonal-f Rff Redi-ject</ProprietaryName>
<NonProprietaryName>Follitropin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20131016</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA021684</ApplicationNumber>
<LabelerName>EMD Serono, Inc.</LabelerName>
<SubstanceName>FOLLITROPIN</SubstanceName>
<StrengthNumber>450</StrengthNumber>
<StrengthUnit>[iU]/.75mL</StrengthUnit>
<Pharm_Classes>Gonadotropin [EPC], Gonadotropins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131016</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GONAL-f® RFF Redi-ject® is a prefilled gonadotropin-containing auto-injection device indicated for: 1 Induction of ovulation and pregnancy in oligo-anovulatory women in whom the cause of infertility is functional and not due to primary ovarian failure (1.1), 2 Development of multiple follicles in ovulatory women as part of an Assisted Reproductive Technology (ART) cycle (1.2).</IndicationAndUsage>
<Description>Follitropin alfa, a gonadotropin [human follicle stimulating hormone (hFSH)], is a glycoprotein hormone produced by recombinant DNA technology in a Chinese Hamster Ovary (CHO) cell line. It has a dimeric structure consisting of two glycoprotein subunits (alpha and beta). The alpha and beta subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structures are indistinguishable from those of human follicle stimulating hormone. The molecular weight is approximately 31 kDa (14 kDa for alpha subunit and 17 kDa for beta subunit). GONAL-f® RFF Redi-ject® (follitropin alfa) injection is a sterile, clear and colorless to slightly yellow solution in disposable, prefilled single-patient-use pen intended for the subcutaneous use. Each GONAL-f® RFF Redi-ject® pen delivers 300 International Units (22 mcg) follitropin alfa in 0.48 mL and the inactive ingredients: dibasic sodium phosphate (0.43 mg), m-cresol (1.47 mg), methionine (0.05 mg), monobasic sodium phosphate (0.19 mg), poloxamer (0.05 mg), sucrose (29.47 mg) and Water for Injection USP. Phosphoric acid and/or sodium hydroxide may be used to adjust the pH to 7. Each GONAL-f® RFF Redi-ject® pen delivers 450 International Units (33 mcg) follitropin alfa in 0.72 mL and the inactive ingredients: dibasic sodium phosphate (0.65 mg), m-cresol (2.21 mg), methionine (0.07 mg), monobasic sodium phosphate (0.29 mg), poloxamer (0.07 mg), sucrose (44.20 mg) and Water for Injection USP. Phosphoric acid and/or sodium hydroxide may be used to adjust the pH to 7. Each GONAL-f® RFF Redi-ject® pen delivers 900 International Units (66 mcg) follitropin alfa in 1.44 mL and the inactive ingredients: dibasic sodium phosphate (1.3 mg), m-cresol (4.42 mg), methionine (0.15 mg), monobasic sodium phosphate (0.58 mg), poloxamer (0.15 mg), sucrose (88.41 mg) and Water for Injection USP. Phosphoric acid and/or sodium hydroxide may be used to adjust the pH to 7. Under current storage conditions, GONAL-f® RFF Redi-ject® may contain up to 10% of oxidized follitropin alfa.</Description>
</NDC>
<NDC>
<NDCCode>44087-1117-1</NDCCode>
<PackageDescription>1 PACKAGE in 1 CARTON (44087-1117-1) / 1.5 mL in 1 PACKAGE</PackageDescription>
<NDC11Code>44087-1117-01</NDC11Code>
<ProductNDC>44087-1117</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gonal-f Rff Redi-ject</ProprietaryName>
<NonProprietaryName>Follitropin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20131016</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA021684</ApplicationNumber>
<LabelerName>EMD Serono, Inc.</LabelerName>
<SubstanceName>FOLLITROPIN</SubstanceName>
<StrengthNumber>900</StrengthNumber>
<StrengthUnit>[iU]/1.5mL</StrengthUnit>
<Pharm_Classes>Gonadotropin [EPC], Gonadotropins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131016</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GONAL-f® RFF Redi-ject® is a prefilled gonadotropin-containing auto-injection device indicated for: 1 Induction of ovulation and pregnancy in oligo-anovulatory women in whom the cause of infertility is functional and not due to primary ovarian failure (1.1), 2 Development of multiple follicles in ovulatory women as part of an Assisted Reproductive Technology (ART) cycle (1.2).</IndicationAndUsage>
<Description>Follitropin alfa, a gonadotropin [human follicle stimulating hormone (hFSH)], is a glycoprotein hormone produced by recombinant DNA technology in a Chinese Hamster Ovary (CHO) cell line. It has a dimeric structure consisting of two glycoprotein subunits (alpha and beta). The alpha and beta subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structures are indistinguishable from those of human follicle stimulating hormone. The molecular weight is approximately 31 kDa (14 kDa for alpha subunit and 17 kDa for beta subunit). GONAL-f® RFF Redi-ject® (follitropin alfa) injection is a sterile, clear and colorless to slightly yellow solution in disposable, prefilled single-patient-use pen intended for the subcutaneous use. Each GONAL-f® RFF Redi-ject® pen delivers 300 International Units (22 mcg) follitropin alfa in 0.48 mL and the inactive ingredients: dibasic sodium phosphate (0.43 mg), m-cresol (1.47 mg), methionine (0.05 mg), monobasic sodium phosphate (0.19 mg), poloxamer (0.05 mg), sucrose (29.47 mg) and Water for Injection USP. Phosphoric acid and/or sodium hydroxide may be used to adjust the pH to 7. Each GONAL-f® RFF Redi-ject® pen delivers 450 International Units (33 mcg) follitropin alfa in 0.72 mL and the inactive ingredients: dibasic sodium phosphate (0.65 mg), m-cresol (2.21 mg), methionine (0.07 mg), monobasic sodium phosphate (0.29 mg), poloxamer (0.07 mg), sucrose (44.20 mg) and Water for Injection USP. Phosphoric acid and/or sodium hydroxide may be used to adjust the pH to 7. Each GONAL-f® RFF Redi-ject® pen delivers 900 International Units (66 mcg) follitropin alfa in 1.44 mL and the inactive ingredients: dibasic sodium phosphate (1.3 mg), m-cresol (4.42 mg), methionine (0.15 mg), monobasic sodium phosphate (0.58 mg), poloxamer (0.15 mg), sucrose (88.41 mg) and Water for Injection USP. Phosphoric acid and/or sodium hydroxide may be used to adjust the pH to 7. Under current storage conditions, GONAL-f® RFF Redi-ject® may contain up to 10% of oxidized follitropin alfa.</Description>
</NDC>
<NDC>
<NDCCode>58103-111-10</NDCCode>
<PackageDescription>100 kg in 1 DRUM (58103-111-10)</PackageDescription>
<NDC11Code>58103-0111-10</NDC11Code>
<ProductNDC>58103-111</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Calcium Carbonate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20110404</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>SPI Pharma, Inc.</LabelerName>
<SubstanceName>CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>58</StrengthNumber>
<StrengthUnit>kg/100kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>78206-129-59</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (78206-129-59) / 1 CARTRIDGE in 1 KIT / .36 mL in 1 CARTRIDGE (78206-129-58) </PackageDescription>
<NDC11Code>78206-0129-59</NDC11Code>
<ProductNDC>78206-129</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Follistim Aq</ProprietaryName>
<NonProprietaryName>Follitropin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20230724</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA021211</ApplicationNumber>
<LabelerName>Organon LLC</LabelerName>
<SubstanceName>FOLLITROPIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>[iU]/.36mL</StrengthUnit>
<Pharm_Classes>Gonadotropin [EPC], Gonadotropins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230724</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>FOLLISTIM® AQ Cartridge (follitropin beta) injection, is indicated. In Women for.</IndicationAndUsage>
<Description>Follitropin beta, a gonadotropin [human follicle-stimulating hormone (hFSH)], is a glycoprotein hormone produced by recombinant DNA technology in a Chinese hamster ovary (CHO) cell line. It has a dimeric structure containing two glycoprotein subunits (alpha and beta). The alpha and beta subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structures are indistinguishable from that of hFSH. The molecular weight is approximately 40 kDa. FOLLISTIM AQ Cartridge (follitropin beta) injection is a sterile clear and colorless solution, containing either 300 International Units, 600 International Units, or 900 International Units of follitropin beta in disposable single-patient-use cartridges for subcutaneous use only with the FOLLISTIM Pen. Each cartridge delivers 300 International Units in 0.36 mL and the inactive ingredients: benzyl alcohol (3.6 mg; preservative), methionine (0.18 mg), polysorbate 20 (0.072 mg), sodium citrate (4.64 mg), sucrose (18 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 600 International Units in 0.72 mL and the inactive ingredients: benzyl alcohol (7.2 mg; preservative), methionine (0.36 mg), polysorbate 20 (0.144 mg), sodium citrate (9.3 mg), sucrose (36 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 900 International Units in 1.08 mL and the inactive ingredients: benzyl alcohol (10.8 mg; preservative), methionine (0.54 mg), polysorbate 20 (0.216 mg), sodium citrate (13.9 mg), sucrose (54 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Under current storage conditions, FOLLISTIM AQ may contain up to 11% of oxidized follitropin beta.</Description>
</NDC>
<NDC>
<NDCCode>78206-130-59</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (78206-130-59) / 1 CARTRIDGE in 1 KIT / .72 mL in 1 CARTRIDGE (78206-130-58) </PackageDescription>
<NDC11Code>78206-0130-59</NDC11Code>
<ProductNDC>78206-130</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Follistim Aq</ProprietaryName>
<NonProprietaryName>Follitropin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20230724</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA021211</ApplicationNumber>
<LabelerName>Organon LLC</LabelerName>
<SubstanceName>FOLLITROPIN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>[iU]/.72mL</StrengthUnit>
<Pharm_Classes>Gonadotropin [EPC], Gonadotropins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230724</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>FOLLISTIM® AQ Cartridge (follitropin beta) injection, is indicated. In Women for.</IndicationAndUsage>
<Description>Follitropin beta, a gonadotropin [human follicle-stimulating hormone (hFSH)], is a glycoprotein hormone produced by recombinant DNA technology in a Chinese hamster ovary (CHO) cell line. It has a dimeric structure containing two glycoprotein subunits (alpha and beta). The alpha and beta subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structures are indistinguishable from that of hFSH. The molecular weight is approximately 40 kDa. FOLLISTIM AQ Cartridge (follitropin beta) injection is a sterile clear and colorless solution, containing either 300 International Units, 600 International Units, or 900 International Units of follitropin beta in disposable single-patient-use cartridges for subcutaneous use only with the FOLLISTIM Pen. Each cartridge delivers 300 International Units in 0.36 mL and the inactive ingredients: benzyl alcohol (3.6 mg; preservative), methionine (0.18 mg), polysorbate 20 (0.072 mg), sodium citrate (4.64 mg), sucrose (18 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 600 International Units in 0.72 mL and the inactive ingredients: benzyl alcohol (7.2 mg; preservative), methionine (0.36 mg), polysorbate 20 (0.144 mg), sodium citrate (9.3 mg), sucrose (36 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 900 International Units in 1.08 mL and the inactive ingredients: benzyl alcohol (10.8 mg; preservative), methionine (0.54 mg), polysorbate 20 (0.216 mg), sodium citrate (13.9 mg), sucrose (54 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Under current storage conditions, FOLLISTIM AQ may contain up to 11% of oxidized follitropin beta.</Description>
</NDC>
<NDC>
<NDCCode>0019-9050-40</NDCCode>
<PackageDescription>1 KIT in 1 BOX (0019-9050-40) * 1 mL in 1 VIAL, GLASS * 1 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>00019-9050-40</NDC11Code>
<ProductNDC>0019-9050</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Octreoscan</ProprietaryName>
<NonProprietaryName>Indium In -111 Pentetreotide</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20070501</StartMarketingDate>
<EndMarketingDate>20170701</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020314</ApplicationNumber>
<LabelerName>Mallinckrodt Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2017-07-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>0019-9132-06</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CAN (0019-9132-06) > .5 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>00019-9132-06</NDC11Code>
<ProductNDC>0019-9132</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Indium In 111 Chloride</ProprietaryName>
<NonProprietaryName>Indium In 111 Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20071207</StartMarketingDate>
<EndMarketingDate>20170701</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019841</ApplicationNumber>
<LabelerName>Mallinckrodt Inc.</LabelerName>
<SubstanceName>INDIUM CHLORIDE IN-111</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mCi/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-07-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>0025-2818-31</NDCCode>
<PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0025-2818-31) </PackageDescription>
<NDC11Code>00025-2818-31</NDC11Code>
<ProductNDC>0025-2818</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Calan Sr</ProprietaryName>
<NonProprietaryName>Verapamil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201216</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019152</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>VERAPAMIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-03-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CALAN SR is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.</IndicationAndUsage>
<Description>CALAN SR (verapamil hydrochloride) is a calcium ion influx inhibitor (slow-channel blocker or calcium ion antagonist). CALAN SR is available for oral administration as light green, capsule-shaped, scored, film-coated tablets containing 240 mg of verapamil hydrochloride (equivalent to 222.16 mg verapamil free base); as light pink, oval, scored, film-coated tablets containing 180 mg of verapamil hydrochloride (equivalent to 166.62 mg verapamil free base); and as light violet, oval, film-coated tablets containing 120 mg of verapamil hydrochloride (equivalent to 111.08 mg verapamil free base). The tablets are designed for extended-release of the drug in the gastrointestinal tract; extended-release characteristics are not altered when the tablet is divided in half. The structural formula of verapamil HCl is. Verapamil HCl is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, chloroform, and methanol. Verapamil HCl is not chemically related to other cardioactive drugs. Inactive ingredients include alginate, carnauba wax, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl pyrrolidone, talc, titanium dioxide, and coloring agents: 240 mg—D&C Yellow No. 10 Lake and FD&C Blue No. 2 Lake; 120 and 180 mg—iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>0049-0050-01</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (0049-0050-01) / 60 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>00049-0050-01</NDC11Code>
<ProductNDC>0049-0050</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zoloft</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170106</StartMarketingDate>
<EndMarketingDate>20260630</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020990</ApplicationNumber>
<LabelerName>ROERIG</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170106</StartMarketingDatePackage>
<EndMarketingDatePackage>20260630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZOLOFT is indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
<Description>ZOLOFT contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S‑cis)‑4‑(3,4‑dichlorophenyl)‑1,2,3,4‑tetrahydro-N‑methyl‑1‑naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. ZOLOFT tablets for oral administration contain 28.0 mg, 56.0 mg and 111.9 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, D & C Yellow #10 aluminum lake (in 25 mg tablet), FD & C Blue #1 aluminum lake (in 25 mg tablet), FD & C Red #40 aluminum lake (in 25 mg tablet), FD & C Blue #2 aluminum lake (in 50 mg tablet), hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, synthetic yellow iron oxide (in 100 mg tablet), and titanium dioxide. ZOLOFT oral solution is available in a multidose 60 mL bottle. Each mL of solution contains 22.4 mg sertraline hydrochloride equivalent to 20 mg of sertraline. The solution contains the following inactive ingredients: glycerin, alcohol (12%), menthol, butylated hydroxytoluene (BHT). The oral solution must be diluted prior to administration [See Dosage and Administration (2.7)]. The dispenser contains dry natural rubber.</Description>
</NDC>
<NDC>
<NDCCode>0049-4900-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0049-4900-30) </PackageDescription>
<NDC11Code>00049-4900-30</NDC11Code>
<ProductNDC>0049-4900</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zoloft</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920211</StartMarketingDate>
<EndMarketingDate>20260630</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019839</ApplicationNumber>
<LabelerName>ROERIG</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19920211</StartMarketingDatePackage>
<EndMarketingDatePackage>20260630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZOLOFT is indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
<Description>ZOLOFT contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S‑cis)‑4‑(3,4‑dichlorophenyl)‑1,2,3,4‑tetrahydro-N‑methyl‑1‑naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. ZOLOFT tablets for oral administration contain 28.0 mg, 56.0 mg and 111.9 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, D & C Yellow #10 aluminum lake (in 25 mg tablet), FD & C Blue #1 aluminum lake (in 25 mg tablet), FD & C Red #40 aluminum lake (in 25 mg tablet), FD & C Blue #2 aluminum lake (in 50 mg tablet), hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, synthetic yellow iron oxide (in 100 mg tablet), and titanium dioxide. ZOLOFT oral solution is available in a multidose 60 mL bottle. Each mL of solution contains 22.4 mg sertraline hydrochloride equivalent to 20 mg of sertraline. The solution contains the following inactive ingredients: glycerin, alcohol (12%), menthol, butylated hydroxytoluene (BHT). The oral solution must be diluted prior to administration [See Dosage and Administration (2.7)]. The dispenser contains dry natural rubber.</Description>
</NDC>
<NDC>
<NDCCode>0049-4900-41</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (0049-4900-41) / 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00049-4900-41</NDC11Code>
<ProductNDC>0049-4900</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zoloft</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920211</StartMarketingDate>
<EndMarketingDate>20260630</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019839</ApplicationNumber>
<LabelerName>ROERIG</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19920211</StartMarketingDatePackage>
<EndMarketingDatePackage>20260630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZOLOFT is indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
<Description>ZOLOFT contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S‑cis)‑4‑(3,4‑dichlorophenyl)‑1,2,3,4‑tetrahydro-N‑methyl‑1‑naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. ZOLOFT tablets for oral administration contain 28.0 mg, 56.0 mg and 111.9 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, D & C Yellow #10 aluminum lake (in 25 mg tablet), FD & C Blue #1 aluminum lake (in 25 mg tablet), FD & C Red #40 aluminum lake (in 25 mg tablet), FD & C Blue #2 aluminum lake (in 50 mg tablet), hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, synthetic yellow iron oxide (in 100 mg tablet), and titanium dioxide. ZOLOFT oral solution is available in a multidose 60 mL bottle. Each mL of solution contains 22.4 mg sertraline hydrochloride equivalent to 20 mg of sertraline. The solution contains the following inactive ingredients: glycerin, alcohol (12%), menthol, butylated hydroxytoluene (BHT). The oral solution must be diluted prior to administration [See Dosage and Administration (2.7)]. The dispenser contains dry natural rubber.</Description>
</NDC>
<NDC>
<NDCCode>0049-4910-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0049-4910-30) </PackageDescription>
<NDC11Code>00049-4910-30</NDC11Code>
<ProductNDC>0049-4910</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zoloft</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920211</StartMarketingDate>
<EndMarketingDate>20260630</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019839</ApplicationNumber>
<LabelerName>ROERIG</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19920211</StartMarketingDatePackage>
<EndMarketingDatePackage>20260630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZOLOFT is indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
<Description>ZOLOFT contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S‑cis)‑4‑(3,4‑dichlorophenyl)‑1,2,3,4‑tetrahydro-N‑methyl‑1‑naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. ZOLOFT tablets for oral administration contain 28.0 mg, 56.0 mg and 111.9 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, D & C Yellow #10 aluminum lake (in 25 mg tablet), FD & C Blue #1 aluminum lake (in 25 mg tablet), FD & C Red #40 aluminum lake (in 25 mg tablet), FD & C Blue #2 aluminum lake (in 50 mg tablet), hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, synthetic yellow iron oxide (in 100 mg tablet), and titanium dioxide. ZOLOFT oral solution is available in a multidose 60 mL bottle. Each mL of solution contains 22.4 mg sertraline hydrochloride equivalent to 20 mg of sertraline. The solution contains the following inactive ingredients: glycerin, alcohol (12%), menthol, butylated hydroxytoluene (BHT). The oral solution must be diluted prior to administration [See Dosage and Administration (2.7)]. The dispenser contains dry natural rubber.</Description>
</NDC>
<NDC>
<NDCCode>0049-4910-41</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (0049-4910-41) / 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00049-4910-41</NDC11Code>
<ProductNDC>0049-4910</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zoloft</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920211</StartMarketingDate>
<EndMarketingDate>20260630</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019839</ApplicationNumber>
<LabelerName>ROERIG</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19920211</StartMarketingDatePackage>
<EndMarketingDatePackage>20260630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZOLOFT is indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
<Description>ZOLOFT contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S‑cis)‑4‑(3,4‑dichlorophenyl)‑1,2,3,4‑tetrahydro-N‑methyl‑1‑naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. ZOLOFT tablets for oral administration contain 28.0 mg, 56.0 mg and 111.9 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, D & C Yellow #10 aluminum lake (in 25 mg tablet), FD & C Blue #1 aluminum lake (in 25 mg tablet), FD & C Red #40 aluminum lake (in 25 mg tablet), FD & C Blue #2 aluminum lake (in 50 mg tablet), hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, synthetic yellow iron oxide (in 100 mg tablet), and titanium dioxide. ZOLOFT oral solution is available in a multidose 60 mL bottle. Each mL of solution contains 22.4 mg sertraline hydrochloride equivalent to 20 mg of sertraline. The solution contains the following inactive ingredients: glycerin, alcohol (12%), menthol, butylated hydroxytoluene (BHT). The oral solution must be diluted prior to administration [See Dosage and Administration (2.7)]. The dispenser contains dry natural rubber.</Description>
</NDC>
<NDC>
<NDCCode>0049-4960-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0049-4960-30) </PackageDescription>
<NDC11Code>00049-4960-30</NDC11Code>
<ProductNDC>0049-4960</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zoloft</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920211</StartMarketingDate>
<EndMarketingDate>20251031</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019839</ApplicationNumber>
<LabelerName>ROERIG</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19920211</StartMarketingDatePackage>
<EndMarketingDatePackage>20251031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZOLOFT is indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
<Description>ZOLOFT contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S‑cis)‑4‑(3,4‑dichlorophenyl)‑1,2,3,4‑tetrahydro-N‑methyl‑1‑naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. ZOLOFT tablets for oral administration contain 28.0 mg, 56.0 mg and 111.9 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, D & C Yellow #10 aluminum lake (in 25 mg tablet), FD & C Blue #1 aluminum lake (in 25 mg tablet), FD & C Red #40 aluminum lake (in 25 mg tablet), FD & C Blue #2 aluminum lake (in 50 mg tablet), hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, synthetic yellow iron oxide (in 100 mg tablet), and titanium dioxide. ZOLOFT oral solution is available in a multidose 60 mL bottle. Each mL of solution contains 22.4 mg sertraline hydrochloride equivalent to 20 mg of sertraline. The solution contains the following inactive ingredients: glycerin, alcohol (12%), menthol, butylated hydroxytoluene (BHT). The oral solution must be diluted prior to administration [See Dosage and Administration (2.7)]. The dispenser contains dry natural rubber.</Description>
</NDC>
<NDC>
<NDCCode>0052-0313-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0052-0313-01) / 1 CARTRIDGE in 1 KIT / .42 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>00052-0313-01</NDC11Code>
<ProductNDC>0052-0313</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Follistim Aq</ProprietaryName>
<NonProprietaryName>Follitropin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20040324</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA021211</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>FOLLITROPIN</SubstanceName>
<StrengthNumber>350</StrengthNumber>
<StrengthUnit>[iU]/.42mL</StrengthUnit>
<Pharm_Classes>Gonadotropin [EPC], Gonadotropins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Follistim® AQ Cartridge (follitropin beta) injection, is indicated. In Women for.</IndicationAndUsage>
<Description>Follitropin beta, a gonadotropin [human follicle-stimulating hormone (hFSH)], is a glycoprotein hormone produced by recombinant DNA technology in a Chinese hamster ovary (CHO) cell line. It has a dimeric structure containing two glycoprotein subunits (alpha and beta). The alpha and beta subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structures are indistinguishable from that of hFSH. The molecular weight is approximately 40 kDa. Follistim AQ Cartridge (follitropin beta) injection is a sterile clear and colorless solution, containing either 300 International Units, 600 International Units, or 900 International Units of follitropin beta in disposable single-patient-use cartridges for subcutaneous use only with the Follistim Pen. Each cartridge delivers 300 International Units in 0.36 mL and the inactive ingredients: benzyl alcohol (3.6 mg; preservative), methionine (0.18 mg), polysorbate 20 (0.072 mg), sodium citrate (4.64 mg), sucrose (18 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 600 International Units in 0.72 mL and the inactive ingredients: benzyl alcohol (7.2 mg; preservative), methionine (0.36 mg), polysorbate 20 (0.144 mg), sodium citrate (9.3 mg), sucrose (36 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 900 International Units in 1.08 mL and the inactive ingredients: benzyl alcohol (10.8 mg; preservative), methionine (0.54 mg), polysorbate 20 (0.216 mg), sodium citrate (13.9 mg), sucrose (54 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Under current storage conditions, Follistim AQ may contain up to 11% of oxidized follitropin beta.</Description>
</NDC>
<NDC>
<NDCCode>0052-0313-81</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0052-0313-81) / 1 CARTRIDGE in 1 KIT / .42 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>00052-0313-81</NDC11Code>
<ProductNDC>0052-0313</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Follistim Aq</ProprietaryName>
<NonProprietaryName>Follitropin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20040324</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA021211</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>FOLLITROPIN</SubstanceName>
<StrengthNumber>350</StrengthNumber>
<StrengthUnit>[iU]/.42mL</StrengthUnit>
<Pharm_Classes>Gonadotropin [EPC], Gonadotropins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Follistim® AQ Cartridge (follitropin beta) injection, is indicated. In Women for.</IndicationAndUsage>
<Description>Follitropin beta, a gonadotropin [human follicle-stimulating hormone (hFSH)], is a glycoprotein hormone produced by recombinant DNA technology in a Chinese hamster ovary (CHO) cell line. It has a dimeric structure containing two glycoprotein subunits (alpha and beta). The alpha and beta subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structures are indistinguishable from that of hFSH. The molecular weight is approximately 40 kDa. Follistim AQ Cartridge (follitropin beta) injection is a sterile clear and colorless solution, containing either 300 International Units, 600 International Units, or 900 International Units of follitropin beta in disposable single-patient-use cartridges for subcutaneous use only with the Follistim Pen. Each cartridge delivers 300 International Units in 0.36 mL and the inactive ingredients: benzyl alcohol (3.6 mg; preservative), methionine (0.18 mg), polysorbate 20 (0.072 mg), sodium citrate (4.64 mg), sucrose (18 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 600 International Units in 0.72 mL and the inactive ingredients: benzyl alcohol (7.2 mg; preservative), methionine (0.36 mg), polysorbate 20 (0.144 mg), sodium citrate (9.3 mg), sucrose (36 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 900 International Units in 1.08 mL and the inactive ingredients: benzyl alcohol (10.8 mg; preservative), methionine (0.54 mg), polysorbate 20 (0.216 mg), sodium citrate (13.9 mg), sucrose (54 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Under current storage conditions, Follistim AQ may contain up to 11% of oxidized follitropin beta.</Description>
</NDC>
<NDC>
<NDCCode>0052-0316-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0052-0316-01) / 1 CARTRIDGE in 1 KIT / .78 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>00052-0316-01</NDC11Code>
<ProductNDC>0052-0316</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Follistim Aq</ProprietaryName>
<NonProprietaryName>Follitropin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20040324</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA021211</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>FOLLITROPIN</SubstanceName>
<StrengthNumber>650</StrengthNumber>
<StrengthUnit>[iU]/.78mL</StrengthUnit>
<Pharm_Classes>Gonadotropin [EPC], Gonadotropins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Follistim® AQ Cartridge (follitropin beta) injection, is indicated. In Women for.</IndicationAndUsage>
<Description>Follitropin beta, a gonadotropin [human follicle-stimulating hormone (hFSH)], is a glycoprotein hormone produced by recombinant DNA technology in a Chinese hamster ovary (CHO) cell line. It has a dimeric structure containing two glycoprotein subunits (alpha and beta). The alpha and beta subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structures are indistinguishable from that of hFSH. The molecular weight is approximately 40 kDa. Follistim AQ Cartridge (follitropin beta) injection is a sterile clear and colorless solution, containing either 300 International Units, 600 International Units, or 900 International Units of follitropin beta in disposable single-patient-use cartridges for subcutaneous use only with the Follistim Pen. Each cartridge delivers 300 International Units in 0.36 mL and the inactive ingredients: benzyl alcohol (3.6 mg; preservative), methionine (0.18 mg), polysorbate 20 (0.072 mg), sodium citrate (4.64 mg), sucrose (18 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 600 International Units in 0.72 mL and the inactive ingredients: benzyl alcohol (7.2 mg; preservative), methionine (0.36 mg), polysorbate 20 (0.144 mg), sodium citrate (9.3 mg), sucrose (36 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 900 International Units in 1.08 mL and the inactive ingredients: benzyl alcohol (10.8 mg; preservative), methionine (0.54 mg), polysorbate 20 (0.216 mg), sodium citrate (13.9 mg), sucrose (54 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Under current storage conditions, Follistim AQ may contain up to 11% of oxidized follitropin beta.</Description>
</NDC>
<NDC>
<NDCCode>0052-0316-81</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0052-0316-81) / 1 CARTRIDGE in 1 KIT / .78 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>00052-0316-81</NDC11Code>
<ProductNDC>0052-0316</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Follistim Aq</ProprietaryName>
<NonProprietaryName>Follitropin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20040324</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA021211</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>FOLLITROPIN</SubstanceName>
<StrengthNumber>650</StrengthNumber>
<StrengthUnit>[iU]/.78mL</StrengthUnit>
<Pharm_Classes>Gonadotropin [EPC], Gonadotropins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Follistim® AQ Cartridge (follitropin beta) injection, is indicated. In Women for.</IndicationAndUsage>
<Description>Follitropin beta, a gonadotropin [human follicle-stimulating hormone (hFSH)], is a glycoprotein hormone produced by recombinant DNA technology in a Chinese hamster ovary (CHO) cell line. It has a dimeric structure containing two glycoprotein subunits (alpha and beta). The alpha and beta subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structures are indistinguishable from that of hFSH. The molecular weight is approximately 40 kDa. Follistim AQ Cartridge (follitropin beta) injection is a sterile clear and colorless solution, containing either 300 International Units, 600 International Units, or 900 International Units of follitropin beta in disposable single-patient-use cartridges for subcutaneous use only with the Follistim Pen. Each cartridge delivers 300 International Units in 0.36 mL and the inactive ingredients: benzyl alcohol (3.6 mg; preservative), methionine (0.18 mg), polysorbate 20 (0.072 mg), sodium citrate (4.64 mg), sucrose (18 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 600 International Units in 0.72 mL and the inactive ingredients: benzyl alcohol (7.2 mg; preservative), methionine (0.36 mg), polysorbate 20 (0.144 mg), sodium citrate (9.3 mg), sucrose (36 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 900 International Units in 1.08 mL and the inactive ingredients: benzyl alcohol (10.8 mg; preservative), methionine (0.54 mg), polysorbate 20 (0.216 mg), sodium citrate (13.9 mg), sucrose (54 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Under current storage conditions, Follistim AQ may contain up to 11% of oxidized follitropin beta.</Description>
</NDC>
<NDC>
<NDCCode>0052-0326-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0052-0326-01) / 1 CARTRIDGE in 1 KIT / 1.17 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>00052-0326-01</NDC11Code>
<ProductNDC>0052-0326</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Follistim Aq</ProprietaryName>
<NonProprietaryName>Follitropin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20040324</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA021211</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>FOLLITROPIN</SubstanceName>
<StrengthNumber>975</StrengthNumber>
<StrengthUnit>[iU]/1.17mL</StrengthUnit>
<Pharm_Classes>Gonadotropin [EPC], Gonadotropins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Follistim® AQ Cartridge (follitropin beta) injection, is indicated. In Women for.</IndicationAndUsage>
<Description>Follitropin beta, a gonadotropin [human follicle-stimulating hormone (hFSH)], is a glycoprotein hormone produced by recombinant DNA technology in a Chinese hamster ovary (CHO) cell line. It has a dimeric structure containing two glycoprotein subunits (alpha and beta). The alpha and beta subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structures are indistinguishable from that of hFSH. The molecular weight is approximately 40 kDa. Follistim AQ Cartridge (follitropin beta) injection is a sterile clear and colorless solution, containing either 300 International Units, 600 International Units, or 900 International Units of follitropin beta in disposable single-patient-use cartridges for subcutaneous use only with the Follistim Pen. Each cartridge delivers 300 International Units in 0.36 mL and the inactive ingredients: benzyl alcohol (3.6 mg; preservative), methionine (0.18 mg), polysorbate 20 (0.072 mg), sodium citrate (4.64 mg), sucrose (18 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 600 International Units in 0.72 mL and the inactive ingredients: benzyl alcohol (7.2 mg; preservative), methionine (0.36 mg), polysorbate 20 (0.144 mg), sodium citrate (9.3 mg), sucrose (36 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 900 International Units in 1.08 mL and the inactive ingredients: benzyl alcohol (10.8 mg; preservative), methionine (0.54 mg), polysorbate 20 (0.216 mg), sodium citrate (13.9 mg), sucrose (54 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Under current storage conditions, Follistim AQ may contain up to 11% of oxidized follitropin beta.</Description>
</NDC>
<NDC>
<NDCCode>0093-3560-26</NDCCode>
<PackageDescription>2 CARTON in 1 CARTON (0093-3560-26) / 1 KIT in 1 CARTON (0093-3560-19) * 1 L in 1 POUCH (0093-9043-19) * 1 L in 1 POUCH * 1 L in 1 POUCH (0093-9044-19) </PackageDescription>
<NDC11Code>00093-3560-26</NDC11Code>
<ProductNDC>0093-3560</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Peg-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate And Ascorbic Acid</ProprietaryName>
<NonProprietaryName>Peg-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate And Ascorbic Acid</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20200831</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090145</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2023-02-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200831</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults.</IndicationAndUsage>
<Description>PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution is an osmotic laxative consisting of 6 pouches (2 of Pouch A, 2 of Pouch B and 2 of Lemon Flavor Pack) containing white to yellow free flowing powder with odor of lemon for reconstitution. Each Pouch A contains 100 grams of polyethylene glycol (PEG) 3350, NF, 7.5 grams of sodium sulfate, USP, 2.691 grams of sodium chloride, USP, and 1.015 grams of potassium chloride, USP. Pouch A contains 111.2 g of powder for oral solution. Each Pouch B contains 4.7 grams of ascorbic acid, USP and 5.9 grams of sodium ascorbate, USP. Pouch B contains 10.6 g of powder for oral solution. Each Lemon Flavor pack contains natural lemon flavor; maltodextrin and saccharin sodium. When 1 Pouch A, 1 Pouch B and 1 Lemon Flavor pack are dissolved together in water to a volume of 1 liter, PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution is an oral solution having a lemon taste. The entire, reconstituted, 2-liter PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution colon preparation contains 200 grams of PEG-3350, 15 grams of sodium sulfate, 5.38 grams of sodium chloride, 2.03 grams of potassium chloride, 9.4 grams of ascorbic acid, and 11.8 grams of sodium ascorbate plus the following excipients: sodium saccharin, USP, maltodextrin, NF, and lemon flavoring. A mixing container for reconstitution is enclosed.</Description>
</NDC>
<NDC>
<NDCCode>0316-2062-30</NDCCode>
<PackageDescription>89 mL in 1 TUBE (0316-2062-30) </PackageDescription>
<NDC11Code>00316-2062-30</NDC11Code>
<ProductNDC>0316-2062</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Blue Lizard Kids Spf 50 Sunscreen</ProprietaryName>
<NonProprietaryName>Octisalate And Titanium Dioxide And Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210209</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Crown Laboratories</LabelerName>
<SubstanceName>ZINC OXIDE; TITANIUM DIOXIDE; OCTISALATE</SubstanceName>
<StrengthNumber>111; 59.5; 55.5</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn and photodamage caused by UVA/UVB exposure. Higher SPF gives more sunburn protection. If used as directed with other sun protection measures (see Directions), decreases the risks of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0316-2062-40</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (0316-2062-40) / 148 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00316-2062-40</NDC11Code>
<ProductNDC>0316-2062</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Blue Lizard Kids Spf 50 Sunscreen</ProprietaryName>
<NonProprietaryName>Octisalate And Titanium Dioxide And Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210209</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Crown Laboratories</LabelerName>
<SubstanceName>OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>55.5; 59.5; 111</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn and photodamage caused by UVA/UVB exposure. Higher SPF gives more sunburn protection. If used as directed with other sun protection measures (see Directions), decreases the risks of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0316-2062-45</NDCCode>
<PackageDescription>148 mL in 1 TUBE (0316-2062-45) </PackageDescription>
<NDC11Code>00316-2062-45</NDC11Code>
<ProductNDC>0316-2062</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Blue Lizard Kids Spf 50 Sunscreen</ProprietaryName>
<NonProprietaryName>Octisalate And Titanium Dioxide And Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210209</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Crown Laboratories</LabelerName>
<SubstanceName>ZINC OXIDE; TITANIUM DIOXIDE; OCTISALATE</SubstanceName>
<StrengthNumber>111; 59.5; 55.5</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn and photodamage caused by UVA/UVB exposure. Higher SPF gives more sunburn protection. If used as directed with other sun protection measures (see Directions), decreases the risks of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0316-2062-50</NDCCode>
<PackageDescription>259 mL in 1 BOTTLE, PLASTIC (0316-2062-50) </PackageDescription>
<NDC11Code>00316-2062-50</NDC11Code>
<ProductNDC>0316-2062</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Blue Lizard Kids Spf 50 Sunscreen</ProprietaryName>
<NonProprietaryName>Octisalate And Titanium Dioxide And Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210209</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Crown Laboratories</LabelerName>
<SubstanceName>OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>55.5; 59.5; 111</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-11-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn and photodamage caused by UVA/UVB exposure. Higher SPF gives more sunburn protection. If used as directed with other sun protection measures (see Directions), decreases the risks of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0316-2072-30</NDCCode>
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<NDC11Code>00316-2072-30</NDC11Code>
<ProductNDC>0316-2072</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Blue Lizard Active Spf 50 Sunscreen</ProprietaryName>
<NonProprietaryName>Octisalate And Titanium Dioxide And Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210209</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Crown Laboratories</LabelerName>
<SubstanceName>OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>55.5; 59.5; 111</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-11-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn and photodamage caused by UVA/UVB exposure. Higher SPF gives more sunburn protection. If used as directed with other sun protection measures (see Directions), decreases the risks of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0316-2072-40</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (0316-2072-40) / 148 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00316-2072-40</NDC11Code>
<ProductNDC>0316-2072</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Blue Lizard Active Spf 50 Sunscreen</ProprietaryName>
<NonProprietaryName>Octisalate And Titanium Dioxide And Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210209</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Crown Laboratories</LabelerName>
<SubstanceName>OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>55.5; 59.5; 111</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-11-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn and photodamage caused by UVA/UVB exposure. Higher SPF gives more sunburn protection. If used as directed with other sun protection measures (see Directions), decreases the risks of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0316-2072-45</NDCCode>
<PackageDescription>148 mL in 1 TUBE (0316-2072-45) </PackageDescription>
<NDC11Code>00316-2072-45</NDC11Code>
<ProductNDC>0316-2072</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Blue Lizard Active Spf 50 Sunscreen</ProprietaryName>
<NonProprietaryName>Octisalate And Titanium Dioxide And Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210209</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Crown Laboratories</LabelerName>
<SubstanceName>OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>55.5; 59.5; 111</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-11-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn and photodamage caused by UVA/UVB exposure. Higher SPF gives more sunburn protection. If used as directed with other sun protection measures (see Directions), decreases the risks of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0316-2072-50</NDCCode>
<PackageDescription>259 mL in 1 BOTTLE, PLASTIC (0316-2072-50) </PackageDescription>
<NDC11Code>00316-2072-50</NDC11Code>
<ProductNDC>0316-2072</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Blue Lizard Active Spf 50 Sunscreen</ProprietaryName>
<NonProprietaryName>Octisalate And Titanium Dioxide And Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210209</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Crown Laboratories</LabelerName>
<SubstanceName>OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>55.5; 59.5; 111</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-11-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn and photodamage caused by UVA/UVB exposure. Higher SPF gives more sunburn protection. If used as directed with other sun protection measures (see Directions), decreases the risks of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
</NDCList>