{
"NDC": [
{
"NDCCode": "64762-865-22",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (64762-865-22) > 22 mL in 1 BOTTLE, PUMP",
"NDC11Code": "64762-0865-22",
"ProductNDC": "64762-865",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Oxymetazoline Hydrochloride",
"NonProprietaryName": "Oxymetazoline Hydrochloride",
"DosageFormName": "SPRAY, METERED",
"RouteName": "NASAL",
"StartMarketingDate": "20091104",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Dynamic Pharmaceuticals",
"SubstanceName": "OXYMETAZOLINE HYDROCHLORIDE",
"StrengthNumber": ".2",
"StrengthUnit": "mg/.4mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Temporarily relieves nasal congestion due to: 1 common cold, 2 hay fever, 3 upper respiratory allergies, 4 helps clear nasal passages, 5 shrinks swollen membranes, 6 temporarily relieves sinus congestion and pressure."
},
{
"NDCCode": "64762-864-22",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (64762-864-22) > 22 mL in 1 BOTTLE, PUMP",
"NDC11Code": "64762-0864-22",
"ProductNDC": "64762-864",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Oxymetazoline Hydrochloride",
"NonProprietaryName": "Oxymetazoline Hydrochloride",
"DosageFormName": "SPRAY, METERED",
"RouteName": "NASAL",
"StartMarketingDate": "20091104",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Dynamic Pharmaceuticals",
"SubstanceName": "OXYMETAZOLINE HYDROCHLORIDE",
"StrengthNumber": ".2",
"StrengthUnit": "mg/.4mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Temporarily relieves nasal congestion due to: 1 common cold, 2 hay fever, 3 upper respiratory allergies, 4 helps clear nasal passages, 5 shrinks swollen membranes, 6 temporarily relieves sinus congestion and pressure."
},
{
"NDCCode": "64762-865-15",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (64762-865-15) > 15 mL in 1 BOTTLE, PUMP",
"NDC11Code": "64762-0865-15",
"ProductNDC": "64762-865",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Oxymetazoline Hydrochloride",
"NonProprietaryName": "Oxymetazoline Hydrochloride",
"DosageFormName": "SPRAY, METERED",
"RouteName": "NASAL",
"StartMarketingDate": "20091104",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Dynamic Pharmaceuticals",
"SubstanceName": "OXYMETAZOLINE HYDROCHLORIDE",
"StrengthNumber": ".2",
"StrengthUnit": "mg/.4mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Temporarily relieves nasal congestion due to: 1 common cold, 2 hay fever, 3 upper respiratory allergies, 4 helps clear nasal passages, 5 shrinks swollen membranes, 6 temporarily relieves sinus congestion and pressure."
},
{
"NDCCode": "11701-083-22",
"PackageDescription": "4 g in 1 PACKET (11701-083-22) ",
"NDC11Code": "11701-0083-22",
"ProductNDC": "11701-083",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Critic-aid Clear",
"NonProprietaryName": "Petrolatum",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190122",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Coloplast Corp",
"SubstanceName": "PETROLATUM",
"StrengthNumber": "865",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2026-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190122",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily protects and helps relieve chapped or cracked skin. Helps seal out wetness."
},
{
"NDCCode": "43063-865-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (43063-865-30) ",
"NDC11Code": "43063-0865-30",
"ProductNDC": "43063-865",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Baclofen",
"NonProprietaryName": "Baclofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20051220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077241",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "BACLOFEN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180626",
"SamplePackage": "N",
"IndicationAndUsage": "Baclofen tablets USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions.",
"Description": "Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. Baclofen USP is a white to off-white, odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg baclofen. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, and magnesium stearate."
},
{
"NDCCode": "43063-865-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (43063-865-60) ",
"NDC11Code": "43063-0865-60",
"ProductNDC": "43063-865",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Baclofen",
"NonProprietaryName": "Baclofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20051220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077241",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "BACLOFEN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180626",
"SamplePackage": "N",
"IndicationAndUsage": "Baclofen tablets USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions.",
"Description": "Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. Baclofen USP is a white to off-white, odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg baclofen. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, and magnesium stearate."
},
{
"NDCCode": "43063-865-90",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (43063-865-90) ",
"NDC11Code": "43063-0865-90",
"ProductNDC": "43063-865",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Baclofen",
"NonProprietaryName": "Baclofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20051220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077241",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "BACLOFEN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180626",
"SamplePackage": "N",
"IndicationAndUsage": "Baclofen tablets USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions.",
"Description": "Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. Baclofen USP is a white to off-white, odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg baclofen. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, and magnesium stearate."
},
{
"NDCCode": "59779-865-00",
"PackageDescription": "240 g in 1 BOTTLE (59779-865-00)",
"NDC11Code": "59779-0865-00",
"ProductNDC": "59779-865",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cvs",
"NonProprietaryName": "Sodium Bicarbonate, Sodium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "NASAL",
"StartMarketingDate": "20160301",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "CVS Pharmacy",
"SubstanceName": "SODIUM BICARBONATE; SODIUM CHLORIDE",
"StrengthNumber": "22.2; 77.8",
"StrengthUnit": "mg/.1g; mg/.1g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "See Instruction Sheet Inside Box.",
"Description": "See Instruction Sheet Inside Box. for Complete Directions. and Proper Use."
},
{
"NDCCode": "60687-865-01",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (60687-865-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-865-11) ",
"NDC11Code": "60687-0865-01",
"ProductNDC": "60687-865",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Escitalopram",
"NonProprietaryName": "Escitalopram",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250320",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078032",
"LabelerName": "American Health Packaging",
"SubstanceName": "ESCITALOPRAM OXALATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250320",
"SamplePackage": "N",
"IndicationAndUsage": "Escitalopram is a selective serotonin reuptake inhibitor (SSRI) indicated for the: 1 treatment of major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older ( 1) , 2 treatment of generalized anxiety disorder (GAD) in adults ( 1) .",
"Description": "Escitalopram tablets contains escitalopram a selective serotonin reuptake inhibitor (SSRI), present as escitalopram oxalate salt. Escitalopram is the pure S-enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate is designated S-(+)-1-[3(dimethylamino) propyl]-1-(p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula. The molecular formula is C 20H 21FN 2O C 2H 2O 4 and the molecular weight is 414.40. Escitalopram oxalate, USP occurs as a fine, white to slightly-yellow powder and is freely soluble in methanol and dimethyl sulfoxide (DMSO), soluble in isotonic saline solution, sparingly soluble in water and ethanol, slightly soluble in ethyl acetate, and insoluble in heptane. Escitalopram tablets USP, for oral use, are film-coated, round tablets containing 6.38 mg, 12.75 mg, 25.5 mg escitalopram oxalate in strengths equivalent to 5 mg, 10 mg, and 20 mg, respectively, of escitalopram base. The 10 and 20 mg tablets are scored. The tablets also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, and a film coating agent. The film coating agent, Opadry II White Y-22-7719, contains the following ingredients: hypromellose; polydextrose; polyethylene glycol; triacetin; and titanium dioxide. Meets USP Dissolution Test 2."
},
{
"NDCCode": "61919-865-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (61919-865-30) ",
"NDC11Code": "61919-0865-30",
"ProductNDC": "61919-865",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phentermine Hcl C-iv",
"NonProprietaryName": "Phentermine Hcl C-iv",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20190605",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091359",
"LabelerName": "Direct_Rx",
"SubstanceName": "PHENTERMINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190605",
"SamplePackage": "N",
"IndicationAndUsage": "Phentermine hydrochloride capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. BODY MASS INDEX (BMI), kg/m2. Height (feet, inches) Weight (pounds) 5'0\" 5'3\" 5'6\" 5'9\" 6'0\" 6'3\" 140 27 25 23 21 19 18 150 29 27 24 22 20 19 160 31 28 26 24 22 20 170 33 30 28 25 23 21 180 35 32 29 27 25 23 190 37 34 31 28 26 24 200 39 36 32 30 27 25 210 41 37 34 31 29 26 220 43 39 36 33 30 28 230 45 41 37 34 31 29 240 47 43 39 36 33 30 250 49 44 40 37 34 31. The limited usefulness of agents of this class, including phentermine, [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.",
"Description": "Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. [Phentermine HCl Molecular Structure]. C10H15N HCl M.W. 185.7. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride capsules, USP are available as. a) powder-filled capsules containing 15 mg phentermine hydrochloride (equivalent to 12 mg phentermine base) or 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: corn starch and magnesium stearate. In addition, the 15 mg gray/orange capsules contain lactose monohydrate, gelatin, D&C Yellow # 10, FD&C Red # 40, FD&C Yellow # 6, titanium dioxide, black iron oxide, yellow iron oxide; the 30 mg natural/blue capsules contain lactose anhydrous, gelatin, D&C Red # 28, and FD&C Blue # 1; the 30 mg yellow/yellow capsules contain lactose anhydrous, gelatin, D&C Yellow # 10, FD&C Red # 3, and titanium dioxide; and the 30 mg black/black capsules contain lactose anhydrous, gelatin, FD&C Yellow # 6, FD&C Blue # 1, and FD&C Red # 40. The imprinting ink for the 15 mg gray/orange capsules, 30 mg natural/blue capsules and 30 mg yellow/yellow capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, FD&C Blue # 1 Aluminum Lake, and D&C Yellow # 10 Aluminum Lake. The imprinting ink for the 30 mg black/black capsules contains: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, yellow iron oxide, and dimethicone. b) pellet-filled capsules containing 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: sugar spheres, hypromellose, polyethylene glycol, titanium dioxide, FD&C Blue No. 1 Aluminum Lake, polysorbate 80, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, gelatin, FD&C Blue No. 1 and D&C Red No. 28. The imprinting ink for the pellet-filled capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, FD&C Blue # 1 Aluminum Lake, and D&C Yellow # 10 Aluminum Lake."
},
{
"NDCCode": "61919-865-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (61919-865-90) ",
"NDC11Code": "61919-0865-90",
"ProductNDC": "61919-865",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phentermine Hcl C-iv",
"NonProprietaryName": "Phentermine Hcl C-iv",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20190605",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091359",
"LabelerName": "Direct_Rx",
"SubstanceName": "PHENTERMINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190605",
"SamplePackage": "N",
"IndicationAndUsage": "Phentermine hydrochloride capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. BODY MASS INDEX (BMI), kg/m2. Height (feet, inches) Weight (pounds) 5'0\" 5'3\" 5'6\" 5'9\" 6'0\" 6'3\" 140 27 25 23 21 19 18 150 29 27 24 22 20 19 160 31 28 26 24 22 20 170 33 30 28 25 23 21 180 35 32 29 27 25 23 190 37 34 31 28 26 24 200 39 36 32 30 27 25 210 41 37 34 31 29 26 220 43 39 36 33 30 28 230 45 41 37 34 31 29 240 47 43 39 36 33 30 250 49 44 40 37 34 31. The limited usefulness of agents of this class, including phentermine, [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.",
"Description": "Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. [Phentermine HCl Molecular Structure]. C10H15N HCl M.W. 185.7. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride capsules, USP are available as. a) powder-filled capsules containing 15 mg phentermine hydrochloride (equivalent to 12 mg phentermine base) or 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: corn starch and magnesium stearate. In addition, the 15 mg gray/orange capsules contain lactose monohydrate, gelatin, D&C Yellow # 10, FD&C Red # 40, FD&C Yellow # 6, titanium dioxide, black iron oxide, yellow iron oxide; the 30 mg natural/blue capsules contain lactose anhydrous, gelatin, D&C Red # 28, and FD&C Blue # 1; the 30 mg yellow/yellow capsules contain lactose anhydrous, gelatin, D&C Yellow # 10, FD&C Red # 3, and titanium dioxide; and the 30 mg black/black capsules contain lactose anhydrous, gelatin, FD&C Yellow # 6, FD&C Blue # 1, and FD&C Red # 40. The imprinting ink for the 15 mg gray/orange capsules, 30 mg natural/blue capsules and 30 mg yellow/yellow capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, FD&C Blue # 1 Aluminum Lake, and D&C Yellow # 10 Aluminum Lake. The imprinting ink for the 30 mg black/black capsules contains: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, yellow iron oxide, and dimethicone. b) pellet-filled capsules containing 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: sugar spheres, hypromellose, polyethylene glycol, titanium dioxide, FD&C Blue No. 1 Aluminum Lake, polysorbate 80, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, gelatin, FD&C Blue No. 1 and D&C Red No. 28. The imprinting ink for the pellet-filled capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, FD&C Blue # 1 Aluminum Lake, and D&C Yellow # 10 Aluminum Lake."
},
{
"NDCCode": "71205-865-00",
"PackageDescription": "100 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-865-00) ",
"NDC11Code": "71205-0865-00",
"ProductNDC": "71205-865",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium Misoprostol",
"NonProprietaryName": "Diclofenac Sodium And Misoprostol",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20210715",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205143",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "DICLOFENAC SODIUM; MISOPROSTOL",
"StrengthNumber": "50; 200",
"StrengthUnit": "mg/1; ug/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]",
"Status": "Active",
"LastUpdate": "2022-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220307",
"SamplePackage": "N",
"IndicationAndUsage": "Diclofenac sodium and misoprostol delayed-release tablets are indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. For a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications [see Warnings and Precautions (5.2)].",
"Description": "Diclofenac sodium and misoprostol delayed-release tablets, USP are a combination product containing diclofenac sodium, an NSAID with analgesic properties, and misoprostol, a gastrointestinal (GI) mucosal protective prostaglandin-1 (PGE1) analog. Diclofenac sodium and misoprostol delayed-release tablets, USP are white to off-white, round, biconvex, and approximately 12.7 mm in diameter. Each 50 mg/200 mcg tablet consists of an enteric-coated core containing 50 mg diclofenac sodium surrounded by an outer mantel containing 200 mcg misoprostol. Each 75 mg/200 mcg tablet consists of an enteric-coated core containing 75 mg diclofenac sodium surrounded by an outer mantle containing 200 mcg misprostol. Diclofenac sodium is a phenylacetic acid derivative that is a white to off-white, virtually odorless, crystalline powder. Diclofenac sodium is freely soluble in methanol, soluble in ethanol, and practically insoluble in chloroform and in dilute acid. Diclofenac sodium is sparingly soluble in water. Its chemical formula and name are. C14H10Cl2NO2Na [M.W. = 318.14] 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, monosodium salt. Misoprostol is a water-soluble, viscous liquid that contains approximately equal amounts of two diastereomers. Its chemical formula and name are. C22H38O5 [M.W. = 382.54] (±) methyl 11α,16-dihydroxy-16-methyl-9-oxoprost-13E-en-1-oate. Inactive ingredients in diclofenac sodium and misoprostol delayed-release tablets include: colloidal silicon dioxide; crospovidone; hypromellose; lactose; magnesium stearate; methacrylic acid copolymer; microcrystalline cellulose; polyethylene glycol (400); povidone (polyvidone) K-30; starch (corn); titanium dioxide; triethyl citrate; Carnauba wax."
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{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium Misoprostol",
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"IndicationAndUsage": "Diclofenac sodium and misoprostol delayed-release tablets are indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. For a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications [see Warnings and Precautions (5.2)].",
"Description": "Diclofenac sodium and misoprostol delayed-release tablets, USP are a combination product containing diclofenac sodium, an NSAID with analgesic properties, and misoprostol, a gastrointestinal (GI) mucosal protective prostaglandin-1 (PGE1) analog. Diclofenac sodium and misoprostol delayed-release tablets, USP are white to off-white, round, biconvex, and approximately 12.7 mm in diameter. Each 50 mg/200 mcg tablet consists of an enteric-coated core containing 50 mg diclofenac sodium surrounded by an outer mantel containing 200 mcg misoprostol. Each 75 mg/200 mcg tablet consists of an enteric-coated core containing 75 mg diclofenac sodium surrounded by an outer mantle containing 200 mcg misprostol. Diclofenac sodium is a phenylacetic acid derivative that is a white to off-white, virtually odorless, crystalline powder. Diclofenac sodium is freely soluble in methanol, soluble in ethanol, and practically insoluble in chloroform and in dilute acid. Diclofenac sodium is sparingly soluble in water. Its chemical formula and name are. C14H10Cl2NO2Na [M.W. = 318.14] 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, monosodium salt. Misoprostol is a water-soluble, viscous liquid that contains approximately equal amounts of two diastereomers. Its chemical formula and name are. C22H38O5 [M.W. = 382.54] (±) methyl 11α,16-dihydroxy-16-methyl-9-oxoprost-13E-en-1-oate. Inactive ingredients in diclofenac sodium and misoprostol delayed-release tablets include: colloidal silicon dioxide; crospovidone; hypromellose; lactose; magnesium stearate; methacrylic acid copolymer; microcrystalline cellulose; polyethylene glycol (400); povidone (polyvidone) K-30; starch (corn); titanium dioxide; triethyl citrate; Carnauba wax."
},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium Misoprostol",
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"IndicationAndUsage": "Diclofenac sodium and misoprostol delayed-release tablets are indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. For a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications [see Warnings and Precautions (5.2)].",
"Description": "Diclofenac sodium and misoprostol delayed-release tablets, USP are a combination product containing diclofenac sodium, an NSAID with analgesic properties, and misoprostol, a gastrointestinal (GI) mucosal protective prostaglandin-1 (PGE1) analog. Diclofenac sodium and misoprostol delayed-release tablets, USP are white to off-white, round, biconvex, and approximately 12.7 mm in diameter. Each 50 mg/200 mcg tablet consists of an enteric-coated core containing 50 mg diclofenac sodium surrounded by an outer mantel containing 200 mcg misoprostol. Each 75 mg/200 mcg tablet consists of an enteric-coated core containing 75 mg diclofenac sodium surrounded by an outer mantle containing 200 mcg misprostol. Diclofenac sodium is a phenylacetic acid derivative that is a white to off-white, virtually odorless, crystalline powder. Diclofenac sodium is freely soluble in methanol, soluble in ethanol, and practically insoluble in chloroform and in dilute acid. Diclofenac sodium is sparingly soluble in water. Its chemical formula and name are. C14H10Cl2NO2Na [M.W. = 318.14] 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, monosodium salt. Misoprostol is a water-soluble, viscous liquid that contains approximately equal amounts of two diastereomers. Its chemical formula and name are. C22H38O5 [M.W. = 382.54] (±) methyl 11α,16-dihydroxy-16-methyl-9-oxoprost-13E-en-1-oate. Inactive ingredients in diclofenac sodium and misoprostol delayed-release tablets include: colloidal silicon dioxide; crospovidone; hypromellose; lactose; magnesium stearate; methacrylic acid copolymer; microcrystalline cellulose; polyethylene glycol (400); povidone (polyvidone) K-30; starch (corn); titanium dioxide; triethyl citrate; Carnauba wax."
},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium Misoprostol",
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"IndicationAndUsage": "Diclofenac sodium and misoprostol delayed-release tablets are indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. For a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications [see Warnings and Precautions (5.2)].",
"Description": "Diclofenac sodium and misoprostol delayed-release tablets, USP are a combination product containing diclofenac sodium, an NSAID with analgesic properties, and misoprostol, a gastrointestinal (GI) mucosal protective prostaglandin-1 (PGE1) analog. Diclofenac sodium and misoprostol delayed-release tablets, USP are white to off-white, round, biconvex, and approximately 12.7 mm in diameter. Each 50 mg/200 mcg tablet consists of an enteric-coated core containing 50 mg diclofenac sodium surrounded by an outer mantel containing 200 mcg misoprostol. Each 75 mg/200 mcg tablet consists of an enteric-coated core containing 75 mg diclofenac sodium surrounded by an outer mantle containing 200 mcg misprostol. Diclofenac sodium is a phenylacetic acid derivative that is a white to off-white, virtually odorless, crystalline powder. Diclofenac sodium is freely soluble in methanol, soluble in ethanol, and practically insoluble in chloroform and in dilute acid. Diclofenac sodium is sparingly soluble in water. Its chemical formula and name are. C14H10Cl2NO2Na [M.W. = 318.14] 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, monosodium salt. Misoprostol is a water-soluble, viscous liquid that contains approximately equal amounts of two diastereomers. Its chemical formula and name are. C22H38O5 [M.W. = 382.54] (±) methyl 11α,16-dihydroxy-16-methyl-9-oxoprost-13E-en-1-oate. Inactive ingredients in diclofenac sodium and misoprostol delayed-release tablets include: colloidal silicon dioxide; crospovidone; hypromellose; lactose; magnesium stearate; methacrylic acid copolymer; microcrystalline cellulose; polyethylene glycol (400); povidone (polyvidone) K-30; starch (corn); titanium dioxide; triethyl citrate; Carnauba wax."
},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]",
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"IndicationAndUsage": "Diclofenac sodium and misoprostol delayed-release tablets are indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. For a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications [see Warnings and Precautions (5.2)].",
"Description": "Diclofenac sodium and misoprostol delayed-release tablets, USP are a combination product containing diclofenac sodium, an NSAID with analgesic properties, and misoprostol, a gastrointestinal (GI) mucosal protective prostaglandin-1 (PGE1) analog. Diclofenac sodium and misoprostol delayed-release tablets, USP are white to off-white, round, biconvex, and approximately 12.7 mm in diameter. Each 50 mg/200 mcg tablet consists of an enteric-coated core containing 50 mg diclofenac sodium surrounded by an outer mantel containing 200 mcg misoprostol. Each 75 mg/200 mcg tablet consists of an enteric-coated core containing 75 mg diclofenac sodium surrounded by an outer mantle containing 200 mcg misprostol. Diclofenac sodium is a phenylacetic acid derivative that is a white to off-white, virtually odorless, crystalline powder. Diclofenac sodium is freely soluble in methanol, soluble in ethanol, and practically insoluble in chloroform and in dilute acid. Diclofenac sodium is sparingly soluble in water. Its chemical formula and name are. C14H10Cl2NO2Na [M.W. = 318.14] 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, monosodium salt. Misoprostol is a water-soluble, viscous liquid that contains approximately equal amounts of two diastereomers. Its chemical formula and name are. C22H38O5 [M.W. = 382.54] (±) methyl 11α,16-dihydroxy-16-methyl-9-oxoprost-13E-en-1-oate. Inactive ingredients in diclofenac sodium and misoprostol delayed-release tablets include: colloidal silicon dioxide; crospovidone; hypromellose; lactose; magnesium stearate; methacrylic acid copolymer; microcrystalline cellulose; polyethylene glycol (400); povidone (polyvidone) K-30; starch (corn); titanium dioxide; triethyl citrate; Carnauba wax."
},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]",
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"IndicationAndUsage": "Diclofenac sodium and misoprostol delayed-release tablets are indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. For a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications [see Warnings and Precautions (5.2)].",
"Description": "Diclofenac sodium and misoprostol delayed-release tablets, USP are a combination product containing diclofenac sodium, an NSAID with analgesic properties, and misoprostol, a gastrointestinal (GI) mucosal protective prostaglandin-1 (PGE1) analog. Diclofenac sodium and misoprostol delayed-release tablets, USP are white to off-white, round, biconvex, and approximately 12.7 mm in diameter. Each 50 mg/200 mcg tablet consists of an enteric-coated core containing 50 mg diclofenac sodium surrounded by an outer mantel containing 200 mcg misoprostol. Each 75 mg/200 mcg tablet consists of an enteric-coated core containing 75 mg diclofenac sodium surrounded by an outer mantle containing 200 mcg misprostol. Diclofenac sodium is a phenylacetic acid derivative that is a white to off-white, virtually odorless, crystalline powder. Diclofenac sodium is freely soluble in methanol, soluble in ethanol, and practically insoluble in chloroform and in dilute acid. Diclofenac sodium is sparingly soluble in water. Its chemical formula and name are. C14H10Cl2NO2Na [M.W. = 318.14] 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, monosodium salt. Misoprostol is a water-soluble, viscous liquid that contains approximately equal amounts of two diastereomers. Its chemical formula and name are. C22H38O5 [M.W. = 382.54] (±) methyl 11α,16-dihydroxy-16-methyl-9-oxoprost-13E-en-1-oate. Inactive ingredients in diclofenac sodium and misoprostol delayed-release tablets include: colloidal silicon dioxide; crospovidone; hypromellose; lactose; magnesium stearate; methacrylic acid copolymer; microcrystalline cellulose; polyethylene glycol (400); povidone (polyvidone) K-30; starch (corn); titanium dioxide; triethyl citrate; Carnauba wax."
},
{
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"IndicationAndUsage": "Diclofenac sodium and misoprostol delayed-release tablets are indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. For a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications [see Warnings and Precautions (5.2)].",
"Description": "Diclofenac sodium and misoprostol delayed-release tablets, USP are a combination product containing diclofenac sodium, an NSAID with analgesic properties, and misoprostol, a gastrointestinal (GI) mucosal protective prostaglandin-1 (PGE1) analog. Diclofenac sodium and misoprostol delayed-release tablets, USP are white to off-white, round, biconvex, and approximately 12.7 mm in diameter. Each 50 mg/200 mcg tablet consists of an enteric-coated core containing 50 mg diclofenac sodium surrounded by an outer mantel containing 200 mcg misoprostol. Each 75 mg/200 mcg tablet consists of an enteric-coated core containing 75 mg diclofenac sodium surrounded by an outer mantle containing 200 mcg misprostol. Diclofenac sodium is a phenylacetic acid derivative that is a white to off-white, virtually odorless, crystalline powder. Diclofenac sodium is freely soluble in methanol, soluble in ethanol, and practically insoluble in chloroform and in dilute acid. Diclofenac sodium is sparingly soluble in water. Its chemical formula and name are. C14H10Cl2NO2Na [M.W. = 318.14] 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, monosodium salt. Misoprostol is a water-soluble, viscous liquid that contains approximately equal amounts of two diastereomers. Its chemical formula and name are. C22H38O5 [M.W. = 382.54] (±) methyl 11α,16-dihydroxy-16-methyl-9-oxoprost-13E-en-1-oate. Inactive ingredients in diclofenac sodium and misoprostol delayed-release tablets include: colloidal silicon dioxide; crospovidone; hypromellose; lactose; magnesium stearate; methacrylic acid copolymer; microcrystalline cellulose; polyethylene glycol (400); povidone (polyvidone) K-30; starch (corn); titanium dioxide; triethyl citrate; Carnauba wax."
},
{
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"ProductNDC": "64762-861",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nbb Cherry",
"NonProprietaryName": "Zinc Gluconate, Zinc Oxide, And Sambucus Nigra Flower",
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"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
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"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Reduces duration of common cold. Reduces severity of cold symptoms: stuffy nose, sneezing, sore throat, coughing, and congestion."
},
{
"NDCCode": "64762-861-30",
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"LabelerName": "Dynamic Pharmaceuticals Inc.",
"SubstanceName": "ZINC GLUCONATE; ZINC OXIDE; SAMBUCUS NIGRA FLOWER",
"StrengthNumber": "1; 1; 1",
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"Status": "Deprecated",
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"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Reduces duration of common cold. Reduces severity of cold symptoms: stuffy nose, sneezing, sore throat, coughing, and congestion."
},
{
"NDCCode": "64762-862-30",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (64762-862-30) > 30 mL in 1 BOTTLE, PUMP",
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"ProductNDC": "64762-862",
"ProductTypeName": "HUMAN OTC DRUG",
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"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Dynamic Pharmaceuticals Inc.",
"SubstanceName": "ZINC OXIDE; ZINC GLUCONATE; SAMBUCUS NIGRA FLOWERING TOP",
"StrengthNumber": ".25; 12.42; .05",
"StrengthUnit": "mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Reduces duration of the common cold. Reduces severity of cold symptoms: SneezingSore ThroatStuffy NoseCoughingCongestion."
},
{
"NDCCode": "64762-864-15",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (64762-864-15) > 15 mL in 1 BOTTLE, PUMP",
"NDC11Code": "64762-0864-15",
"ProductNDC": "64762-864",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Oxymetazoline Hydrochloride",
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"DosageFormName": "SPRAY, METERED",
"RouteName": "NASAL",
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"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Dynamic Pharmaceuticals",
"SubstanceName": "OXYMETAZOLINE HYDROCHLORIDE",
"StrengthNumber": ".2",
"StrengthUnit": "mg/.4mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Temporarily relieves nasal congestion due to: 1 common cold, 2 hay fever, 3 upper respiratory allergies, 4 helps clear nasal passages, 5 shrinks swollen membranes, 6 temporarily relieves sinus congestion and pressure."
},
{
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"ProductNDC": "64762-870",
"ProductTypeName": "HUMAN OTC DRUG",
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"StartMarketingDate": "20091104",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Dynamic Pharmaceuticals Inc.",
"SubstanceName": "ZINC GLUCONATE; ZINC OXIDE; SAMBUCUS NIGRA FLOWER",
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"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
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"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
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},
{
"NDCCode": "64762-870-30",
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"ProductNDC": "64762-870",
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"StartMarketingDate": "20091104",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Dynamic Pharmaceuticals Inc.",
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"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
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"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Reduces duration of common cold. Reduces severity of cold symptoms: stuffy nose, sneezing, sore throat, coughing, and congestion."
},
{
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"DosageFormName": "SPRAY, METERED",
"RouteName": "ORAL",
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"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "Dynamic Pharmaceuticals Inc.",
"SubstanceName": "ZINC GLUCONATE; ZINC ACETATE",
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"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
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{
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"RouteName": "ORAL",
"StartMarketingDate": "20101004",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Dynamic Pharmaceuticals Inc.",
"SubstanceName": "ZINC ACETATE; ZINC GLUCONATE",
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"StrengthUnit": "[hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Reduces duration of the common cold. Reduces severity of cold symptoms: Sore Throat, Stuffy Nose, Sneezing, Coughing, and Congestion."
},
{
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"StrengthUnit": "[hp_X]/1; [hp_X]/1",
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},
{
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"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Dynamic Pharmaceuticals Inc.",
"SubstanceName": "ZINC GLUCONATE",
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"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
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},
{
"NDCCode": "0409-4162-03",
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"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019438",
"LabelerName": "Hospira, Inc.",
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"Pharm_Classes": "Amino Acid [EPC],Amino Acids [CS]",
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"LastUpdate": "2019-04-18",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0409-4162-05",
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"ProductNDC": "0409-4162",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aminosyn Ii",
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"StartMarketingDate": "19860403",
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"LabelerName": "Hospira, Inc.",
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"Pharm_Classes": "Amino Acid [EPC],Amino Acids [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-05-23"
}
]
}
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<NDCList>
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<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
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<SubstanceName>OXYMETAZOLINE HYDROCHLORIDE</SubstanceName>
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<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Temporarily relieves nasal congestion due to: 1 common cold, 2 hay fever, 3 upper respiratory allergies, 4 helps clear nasal passages, 5 shrinks swollen membranes, 6 temporarily relieves sinus congestion and pressure.</IndicationAndUsage>
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<SubstanceName>OXYMETAZOLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>mg/.4mL</StrengthUnit>
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<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
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<ProductNDC>64762-865</ProductNDC>
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<NDCCode>11701-083-22</NDCCode>
<PackageDescription>4 g in 1 PACKET (11701-083-22) </PackageDescription>
<NDC11Code>11701-0083-22</NDC11Code>
<ProductNDC>11701-083</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Critic-aid Clear</ProprietaryName>
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<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190122</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily protects and helps relieve chapped or cracked skin. Helps seal out wetness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43063-865-30</NDCCode>
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<ProductNDC>43063-865</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Baclofen</ProprietaryName>
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<Status>Active</Status>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<Description>Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. Baclofen USP is a white to off-white, odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg baclofen. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, and magnesium stearate.</Description>
</NDC>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180626</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<Description>Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. Baclofen USP is a white to off-white, odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg baclofen. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>43063-865-90</NDCCode>
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<Status>Active</Status>
<LastUpdate>2025-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180626</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Baclofen tablets USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions.</IndicationAndUsage>
<Description>Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. Baclofen USP is a white to off-white, odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg baclofen. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, and magnesium stearate.</Description>
</NDC>
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<NDCCode>59779-865-00</NDCCode>
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<ProductNDC>59779-865</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cvs</ProprietaryName>
<NonProprietaryName>Sodium Bicarbonate, Sodium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20160301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>CVS Pharmacy</LabelerName>
<SubstanceName>SODIUM BICARBONATE; SODIUM CHLORIDE</SubstanceName>
<StrengthNumber>22.2; 77.8</StrengthNumber>
<StrengthUnit>mg/.1g; mg/.1g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>See Instruction Sheet Inside Box.</IndicationAndUsage>
<Description>See Instruction Sheet Inside Box. for Complete Directions. and Proper Use.</Description>
</NDC>
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<NDCCode>60687-865-01</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (60687-865-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-865-11) </PackageDescription>
<NDC11Code>60687-0865-01</NDC11Code>
<ProductNDC>60687-865</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Escitalopram</ProprietaryName>
<NonProprietaryName>Escitalopram</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250320</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078032</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>ESCITALOPRAM OXALATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250320</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Escitalopram is a selective serotonin reuptake inhibitor (SSRI) indicated for the: 1 treatment of major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older ( 1) , 2 treatment of generalized anxiety disorder (GAD) in adults ( 1) .</IndicationAndUsage>
<Description>Escitalopram tablets contains escitalopram a selective serotonin reuptake inhibitor (SSRI), present as escitalopram oxalate salt. Escitalopram is the pure S-enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate is designated S-(+)-1-[3(dimethylamino) propyl]-1-(p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula. The molecular formula is C 20H 21FN 2O C 2H 2O 4 and the molecular weight is 414.40. Escitalopram oxalate, USP occurs as a fine, white to slightly-yellow powder and is freely soluble in methanol and dimethyl sulfoxide (DMSO), soluble in isotonic saline solution, sparingly soluble in water and ethanol, slightly soluble in ethyl acetate, and insoluble in heptane. Escitalopram tablets USP, for oral use, are film-coated, round tablets containing 6.38 mg, 12.75 mg, 25.5 mg escitalopram oxalate in strengths equivalent to 5 mg, 10 mg, and 20 mg, respectively, of escitalopram base. The 10 and 20 mg tablets are scored. The tablets also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, and a film coating agent. The film coating agent, Opadry II White Y-22-7719, contains the following ingredients: hypromellose; polydextrose; polyethylene glycol; triacetin; and titanium dioxide. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>61919-865-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (61919-865-30) </PackageDescription>
<NDC11Code>61919-0865-30</NDC11Code>
<ProductNDC>61919-865</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phentermine Hcl C-iv</ProprietaryName>
<NonProprietaryName>Phentermine Hcl C-iv</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190605</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091359</ApplicationNumber>
<LabelerName>Direct_Rx</LabelerName>
<SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190605</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phentermine hydrochloride capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. BODY MASS INDEX (BMI), kg/m2. Height (feet, inches) Weight (pounds) 5'0" 5'3" 5'6" 5'9" 6'0" 6'3" 140 27 25 23 21 19 18 150 29 27 24 22 20 19 160 31 28 26 24 22 20 170 33 30 28 25 23 21 180 35 32 29 27 25 23 190 37 34 31 28 26 24 200 39 36 32 30 27 25 210 41 37 34 31 29 26 220 43 39 36 33 30 28 230 45 41 37 34 31 29 240 47 43 39 36 33 30 250 49 44 40 37 34 31. The limited usefulness of agents of this class, including phentermine, [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
<Description>Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. [Phentermine HCl Molecular Structure]. C10H15N HCl M.W. 185.7. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride capsules, USP are available as. a) powder-filled capsules containing 15 mg phentermine hydrochloride (equivalent to 12 mg phentermine base) or 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: corn starch and magnesium stearate. In addition, the 15 mg gray/orange capsules contain lactose monohydrate, gelatin, D&C Yellow # 10, FD&C Red # 40, FD&C Yellow # 6, titanium dioxide, black iron oxide, yellow iron oxide; the 30 mg natural/blue capsules contain lactose anhydrous, gelatin, D&C Red # 28, and FD&C Blue # 1; the 30 mg yellow/yellow capsules contain lactose anhydrous, gelatin, D&C Yellow # 10, FD&C Red # 3, and titanium dioxide; and the 30 mg black/black capsules contain lactose anhydrous, gelatin, FD&C Yellow # 6, FD&C Blue # 1, and FD&C Red # 40. The imprinting ink for the 15 mg gray/orange capsules, 30 mg natural/blue capsules and 30 mg yellow/yellow capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, FD&C Blue # 1 Aluminum Lake, and D&C Yellow # 10 Aluminum Lake. The imprinting ink for the 30 mg black/black capsules contains: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, yellow iron oxide, and dimethicone. b) pellet-filled capsules containing 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: sugar spheres, hypromellose, polyethylene glycol, titanium dioxide, FD&C Blue No. 1 Aluminum Lake, polysorbate 80, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, gelatin, FD&C Blue No. 1 and D&C Red No. 28. The imprinting ink for the pellet-filled capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, FD&C Blue # 1 Aluminum Lake, and D&C Yellow # 10 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>61919-865-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (61919-865-90) </PackageDescription>
<NDC11Code>61919-0865-90</NDC11Code>
<ProductNDC>61919-865</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phentermine Hcl C-iv</ProprietaryName>
<NonProprietaryName>Phentermine Hcl C-iv</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190605</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091359</ApplicationNumber>
<LabelerName>Direct_Rx</LabelerName>
<SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190605</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phentermine hydrochloride capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. BODY MASS INDEX (BMI), kg/m2. Height (feet, inches) Weight (pounds) 5'0" 5'3" 5'6" 5'9" 6'0" 6'3" 140 27 25 23 21 19 18 150 29 27 24 22 20 19 160 31 28 26 24 22 20 170 33 30 28 25 23 21 180 35 32 29 27 25 23 190 37 34 31 28 26 24 200 39 36 32 30 27 25 210 41 37 34 31 29 26 220 43 39 36 33 30 28 230 45 41 37 34 31 29 240 47 43 39 36 33 30 250 49 44 40 37 34 31. The limited usefulness of agents of this class, including phentermine, [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
<Description>Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. [Phentermine HCl Molecular Structure]. C10H15N HCl M.W. 185.7. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride capsules, USP are available as. a) powder-filled capsules containing 15 mg phentermine hydrochloride (equivalent to 12 mg phentermine base) or 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: corn starch and magnesium stearate. In addition, the 15 mg gray/orange capsules contain lactose monohydrate, gelatin, D&C Yellow # 10, FD&C Red # 40, FD&C Yellow # 6, titanium dioxide, black iron oxide, yellow iron oxide; the 30 mg natural/blue capsules contain lactose anhydrous, gelatin, D&C Red # 28, and FD&C Blue # 1; the 30 mg yellow/yellow capsules contain lactose anhydrous, gelatin, D&C Yellow # 10, FD&C Red # 3, and titanium dioxide; and the 30 mg black/black capsules contain lactose anhydrous, gelatin, FD&C Yellow # 6, FD&C Blue # 1, and FD&C Red # 40. The imprinting ink for the 15 mg gray/orange capsules, 30 mg natural/blue capsules and 30 mg yellow/yellow capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, FD&C Blue # 1 Aluminum Lake, and D&C Yellow # 10 Aluminum Lake. The imprinting ink for the 30 mg black/black capsules contains: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, yellow iron oxide, and dimethicone. b) pellet-filled capsules containing 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine base) and inactive ingredients: sugar spheres, hypromellose, polyethylene glycol, titanium dioxide, FD&C Blue No. 1 Aluminum Lake, polysorbate 80, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, gelatin, FD&C Blue No. 1 and D&C Red No. 28. The imprinting ink for the pellet-filled capsules contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, FD&C Blue # 1 Aluminum Lake, and D&C Yellow # 10 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>71205-865-00</NDCCode>
<PackageDescription>100 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-865-00) </PackageDescription>
<NDC11Code>71205-0865-00</NDC11Code>
<ProductNDC>71205-865</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium Misoprostol</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium And Misoprostol</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210715</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205143</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>DICLOFENAC SODIUM; MISOPROSTOL</SubstanceName>
<StrengthNumber>50; 200</StrengthNumber>
<StrengthUnit>mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220307</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diclofenac sodium and misoprostol delayed-release tablets are indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. For a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications [see Warnings and Precautions (5.2)].</IndicationAndUsage>
<Description>Diclofenac sodium and misoprostol delayed-release tablets, USP are a combination product containing diclofenac sodium, an NSAID with analgesic properties, and misoprostol, a gastrointestinal (GI) mucosal protective prostaglandin-1 (PGE1) analog. Diclofenac sodium and misoprostol delayed-release tablets, USP are white to off-white, round, biconvex, and approximately 12.7 mm in diameter. Each 50 mg/200 mcg tablet consists of an enteric-coated core containing 50 mg diclofenac sodium surrounded by an outer mantel containing 200 mcg misoprostol. Each 75 mg/200 mcg tablet consists of an enteric-coated core containing 75 mg diclofenac sodium surrounded by an outer mantle containing 200 mcg misprostol. Diclofenac sodium is a phenylacetic acid derivative that is a white to off-white, virtually odorless, crystalline powder. Diclofenac sodium is freely soluble in methanol, soluble in ethanol, and practically insoluble in chloroform and in dilute acid. Diclofenac sodium is sparingly soluble in water. Its chemical formula and name are. C14H10Cl2NO2Na [M.W. = 318.14] 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, monosodium salt. Misoprostol is a water-soluble, viscous liquid that contains approximately equal amounts of two diastereomers. Its chemical formula and name are. C22H38O5 [M.W. = 382.54] (±) methyl 11α,16-dihydroxy-16-methyl-9-oxoprost-13E-en-1-oate. Inactive ingredients in diclofenac sodium and misoprostol delayed-release tablets include: colloidal silicon dioxide; crospovidone; hypromellose; lactose; magnesium stearate; methacrylic acid copolymer; microcrystalline cellulose; polyethylene glycol (400); povidone (polyvidone) K-30; starch (corn); titanium dioxide; triethyl citrate; Carnauba wax.</Description>
</NDC>
<NDC>
<NDCCode>71205-865-30</NDCCode>
<PackageDescription>30 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-865-30) </PackageDescription>
<NDC11Code>71205-0865-30</NDC11Code>
<ProductNDC>71205-865</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium Misoprostol</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium And Misoprostol</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210715</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205143</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>DICLOFENAC SODIUM; MISOPROSTOL</SubstanceName>
<StrengthNumber>50; 200</StrengthNumber>
<StrengthUnit>mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220307</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diclofenac sodium and misoprostol delayed-release tablets are indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. For a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications [see Warnings and Precautions (5.2)].</IndicationAndUsage>
<Description>Diclofenac sodium and misoprostol delayed-release tablets, USP are a combination product containing diclofenac sodium, an NSAID with analgesic properties, and misoprostol, a gastrointestinal (GI) mucosal protective prostaglandin-1 (PGE1) analog. Diclofenac sodium and misoprostol delayed-release tablets, USP are white to off-white, round, biconvex, and approximately 12.7 mm in diameter. Each 50 mg/200 mcg tablet consists of an enteric-coated core containing 50 mg diclofenac sodium surrounded by an outer mantel containing 200 mcg misoprostol. Each 75 mg/200 mcg tablet consists of an enteric-coated core containing 75 mg diclofenac sodium surrounded by an outer mantle containing 200 mcg misprostol. Diclofenac sodium is a phenylacetic acid derivative that is a white to off-white, virtually odorless, crystalline powder. Diclofenac sodium is freely soluble in methanol, soluble in ethanol, and practically insoluble in chloroform and in dilute acid. Diclofenac sodium is sparingly soluble in water. Its chemical formula and name are. C14H10Cl2NO2Na [M.W. = 318.14] 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, monosodium salt. Misoprostol is a water-soluble, viscous liquid that contains approximately equal amounts of two diastereomers. Its chemical formula and name are. C22H38O5 [M.W. = 382.54] (±) methyl 11α,16-dihydroxy-16-methyl-9-oxoprost-13E-en-1-oate. Inactive ingredients in diclofenac sodium and misoprostol delayed-release tablets include: colloidal silicon dioxide; crospovidone; hypromellose; lactose; magnesium stearate; methacrylic acid copolymer; microcrystalline cellulose; polyethylene glycol (400); povidone (polyvidone) K-30; starch (corn); titanium dioxide; triethyl citrate; Carnauba wax.</Description>
</NDC>
<NDC>
<NDCCode>71205-865-55</NDCCode>
<PackageDescription>500 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-865-55) </PackageDescription>
<NDC11Code>71205-0865-55</NDC11Code>
<ProductNDC>71205-865</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium Misoprostol</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium And Misoprostol</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210715</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205143</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>DICLOFENAC SODIUM; MISOPROSTOL</SubstanceName>
<StrengthNumber>50; 200</StrengthNumber>
<StrengthUnit>mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220307</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diclofenac sodium and misoprostol delayed-release tablets are indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. For a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications [see Warnings and Precautions (5.2)].</IndicationAndUsage>
<Description>Diclofenac sodium and misoprostol delayed-release tablets, USP are a combination product containing diclofenac sodium, an NSAID with analgesic properties, and misoprostol, a gastrointestinal (GI) mucosal protective prostaglandin-1 (PGE1) analog. Diclofenac sodium and misoprostol delayed-release tablets, USP are white to off-white, round, biconvex, and approximately 12.7 mm in diameter. Each 50 mg/200 mcg tablet consists of an enteric-coated core containing 50 mg diclofenac sodium surrounded by an outer mantel containing 200 mcg misoprostol. Each 75 mg/200 mcg tablet consists of an enteric-coated core containing 75 mg diclofenac sodium surrounded by an outer mantle containing 200 mcg misprostol. Diclofenac sodium is a phenylacetic acid derivative that is a white to off-white, virtually odorless, crystalline powder. Diclofenac sodium is freely soluble in methanol, soluble in ethanol, and practically insoluble in chloroform and in dilute acid. Diclofenac sodium is sparingly soluble in water. Its chemical formula and name are. C14H10Cl2NO2Na [M.W. = 318.14] 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, monosodium salt. Misoprostol is a water-soluble, viscous liquid that contains approximately equal amounts of two diastereomers. Its chemical formula and name are. C22H38O5 [M.W. = 382.54] (±) methyl 11α,16-dihydroxy-16-methyl-9-oxoprost-13E-en-1-oate. Inactive ingredients in diclofenac sodium and misoprostol delayed-release tablets include: colloidal silicon dioxide; crospovidone; hypromellose; lactose; magnesium stearate; methacrylic acid copolymer; microcrystalline cellulose; polyethylene glycol (400); povidone (polyvidone) K-30; starch (corn); titanium dioxide; triethyl citrate; Carnauba wax.</Description>
</NDC>
<NDC>
<NDCCode>71205-865-60</NDCCode>
<PackageDescription>60 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-865-60) </PackageDescription>
<NDC11Code>71205-0865-60</NDC11Code>
<ProductNDC>71205-865</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium Misoprostol</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium And Misoprostol</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210715</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205143</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>DICLOFENAC SODIUM; MISOPROSTOL</SubstanceName>
<StrengthNumber>50; 200</StrengthNumber>
<StrengthUnit>mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220307</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diclofenac sodium and misoprostol delayed-release tablets are indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. For a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications [see Warnings and Precautions (5.2)].</IndicationAndUsage>
<Description>Diclofenac sodium and misoprostol delayed-release tablets, USP are a combination product containing diclofenac sodium, an NSAID with analgesic properties, and misoprostol, a gastrointestinal (GI) mucosal protective prostaglandin-1 (PGE1) analog. Diclofenac sodium and misoprostol delayed-release tablets, USP are white to off-white, round, biconvex, and approximately 12.7 mm in diameter. Each 50 mg/200 mcg tablet consists of an enteric-coated core containing 50 mg diclofenac sodium surrounded by an outer mantel containing 200 mcg misoprostol. Each 75 mg/200 mcg tablet consists of an enteric-coated core containing 75 mg diclofenac sodium surrounded by an outer mantle containing 200 mcg misprostol. Diclofenac sodium is a phenylacetic acid derivative that is a white to off-white, virtually odorless, crystalline powder. Diclofenac sodium is freely soluble in methanol, soluble in ethanol, and practically insoluble in chloroform and in dilute acid. Diclofenac sodium is sparingly soluble in water. Its chemical formula and name are. C14H10Cl2NO2Na [M.W. = 318.14] 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, monosodium salt. Misoprostol is a water-soluble, viscous liquid that contains approximately equal amounts of two diastereomers. Its chemical formula and name are. C22H38O5 [M.W. = 382.54] (±) methyl 11α,16-dihydroxy-16-methyl-9-oxoprost-13E-en-1-oate. Inactive ingredients in diclofenac sodium and misoprostol delayed-release tablets include: colloidal silicon dioxide; crospovidone; hypromellose; lactose; magnesium stearate; methacrylic acid copolymer; microcrystalline cellulose; polyethylene glycol (400); povidone (polyvidone) K-30; starch (corn); titanium dioxide; triethyl citrate; Carnauba wax.</Description>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<StartMarketingDatePackage>20220307</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diclofenac sodium and misoprostol delayed-release tablets are indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. For a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications [see Warnings and Precautions (5.2)].</IndicationAndUsage>
<Description>Diclofenac sodium and misoprostol delayed-release tablets, USP are a combination product containing diclofenac sodium, an NSAID with analgesic properties, and misoprostol, a gastrointestinal (GI) mucosal protective prostaglandin-1 (PGE1) analog. Diclofenac sodium and misoprostol delayed-release tablets, USP are white to off-white, round, biconvex, and approximately 12.7 mm in diameter. Each 50 mg/200 mcg tablet consists of an enteric-coated core containing 50 mg diclofenac sodium surrounded by an outer mantel containing 200 mcg misoprostol. Each 75 mg/200 mcg tablet consists of an enteric-coated core containing 75 mg diclofenac sodium surrounded by an outer mantle containing 200 mcg misprostol. Diclofenac sodium is a phenylacetic acid derivative that is a white to off-white, virtually odorless, crystalline powder. Diclofenac sodium is freely soluble in methanol, soluble in ethanol, and practically insoluble in chloroform and in dilute acid. Diclofenac sodium is sparingly soluble in water. Its chemical formula and name are. C14H10Cl2NO2Na [M.W. = 318.14] 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, monosodium salt. Misoprostol is a water-soluble, viscous liquid that contains approximately equal amounts of two diastereomers. Its chemical formula and name are. C22H38O5 [M.W. = 382.54] (±) methyl 11α,16-dihydroxy-16-methyl-9-oxoprost-13E-en-1-oate. Inactive ingredients in diclofenac sodium and misoprostol delayed-release tablets include: colloidal silicon dioxide; crospovidone; hypromellose; lactose; magnesium stearate; methacrylic acid copolymer; microcrystalline cellulose; polyethylene glycol (400); povidone (polyvidone) K-30; starch (corn); titanium dioxide; triethyl citrate; Carnauba wax.</Description>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<StartMarketingDatePackage>20220307</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diclofenac sodium and misoprostol delayed-release tablets are indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. For a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications [see Warnings and Precautions (5.2)].</IndicationAndUsage>
<Description>Diclofenac sodium and misoprostol delayed-release tablets, USP are a combination product containing diclofenac sodium, an NSAID with analgesic properties, and misoprostol, a gastrointestinal (GI) mucosal protective prostaglandin-1 (PGE1) analog. Diclofenac sodium and misoprostol delayed-release tablets, USP are white to off-white, round, biconvex, and approximately 12.7 mm in diameter. Each 50 mg/200 mcg tablet consists of an enteric-coated core containing 50 mg diclofenac sodium surrounded by an outer mantel containing 200 mcg misoprostol. Each 75 mg/200 mcg tablet consists of an enteric-coated core containing 75 mg diclofenac sodium surrounded by an outer mantle containing 200 mcg misprostol. Diclofenac sodium is a phenylacetic acid derivative that is a white to off-white, virtually odorless, crystalline powder. Diclofenac sodium is freely soluble in methanol, soluble in ethanol, and practically insoluble in chloroform and in dilute acid. Diclofenac sodium is sparingly soluble in water. Its chemical formula and name are. C14H10Cl2NO2Na [M.W. = 318.14] 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, monosodium salt. Misoprostol is a water-soluble, viscous liquid that contains approximately equal amounts of two diastereomers. Its chemical formula and name are. C22H38O5 [M.W. = 382.54] (±) methyl 11α,16-dihydroxy-16-methyl-9-oxoprost-13E-en-1-oate. Inactive ingredients in diclofenac sodium and misoprostol delayed-release tablets include: colloidal silicon dioxide; crospovidone; hypromellose; lactose; magnesium stearate; methacrylic acid copolymer; microcrystalline cellulose; polyethylene glycol (400); povidone (polyvidone) K-30; starch (corn); titanium dioxide; triethyl citrate; Carnauba wax.</Description>
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<NDCCode>71205-865-90</NDCCode>
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<ProductNDC>71205-865</ProductNDC>
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<StartMarketingDate>20210715</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205143</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
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<Status>Active</Status>
<LastUpdate>2022-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220307</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diclofenac sodium and misoprostol delayed-release tablets are indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. For a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications [see Warnings and Precautions (5.2)].</IndicationAndUsage>
<Description>Diclofenac sodium and misoprostol delayed-release tablets, USP are a combination product containing diclofenac sodium, an NSAID with analgesic properties, and misoprostol, a gastrointestinal (GI) mucosal protective prostaglandin-1 (PGE1) analog. Diclofenac sodium and misoprostol delayed-release tablets, USP are white to off-white, round, biconvex, and approximately 12.7 mm in diameter. Each 50 mg/200 mcg tablet consists of an enteric-coated core containing 50 mg diclofenac sodium surrounded by an outer mantel containing 200 mcg misoprostol. Each 75 mg/200 mcg tablet consists of an enteric-coated core containing 75 mg diclofenac sodium surrounded by an outer mantle containing 200 mcg misprostol. Diclofenac sodium is a phenylacetic acid derivative that is a white to off-white, virtually odorless, crystalline powder. Diclofenac sodium is freely soluble in methanol, soluble in ethanol, and practically insoluble in chloroform and in dilute acid. Diclofenac sodium is sparingly soluble in water. Its chemical formula and name are. C14H10Cl2NO2Na [M.W. = 318.14] 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, monosodium salt. Misoprostol is a water-soluble, viscous liquid that contains approximately equal amounts of two diastereomers. Its chemical formula and name are. C22H38O5 [M.W. = 382.54] (±) methyl 11α,16-dihydroxy-16-methyl-9-oxoprost-13E-en-1-oate. Inactive ingredients in diclofenac sodium and misoprostol delayed-release tablets include: colloidal silicon dioxide; crospovidone; hypromellose; lactose; magnesium stearate; methacrylic acid copolymer; microcrystalline cellulose; polyethylene glycol (400); povidone (polyvidone) K-30; starch (corn); titanium dioxide; triethyl citrate; Carnauba wax.</Description>
</NDC>
<NDC>
<NDCCode>64762-861-25</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (64762-861-25) > 25 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE</PackageDescription>
<NDC11Code>64762-0861-25</NDC11Code>
<ProductNDC>64762-861</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nbb Cherry</ProprietaryName>
<NonProprietaryName>Zinc Gluconate, Zinc Oxide, And Sambucus Nigra Flower</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091104</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Dynamic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ZINC GLUCONATE; ZINC OXIDE; SAMBUCUS NIGRA FLOWER</SubstanceName>
<StrengthNumber>1; 1; 1</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Reduces duration of common cold. Reduces severity of cold symptoms: stuffy nose, sneezing, sore throat, coughing, and congestion.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>64762-861-30</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (64762-861-30) > 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE</PackageDescription>
<NDC11Code>64762-0861-30</NDC11Code>
<ProductNDC>64762-861</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nbb Cherry</ProprietaryName>
<NonProprietaryName>Zinc Gluconate, Zinc Oxide, And Sambucus Nigra Flower</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091104</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Dynamic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ZINC GLUCONATE; ZINC OXIDE; SAMBUCUS NIGRA FLOWER</SubstanceName>
<StrengthNumber>1; 1; 1</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Reduces duration of common cold. Reduces severity of cold symptoms: stuffy nose, sneezing, sore throat, coughing, and congestion.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>64762-862-30</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (64762-862-30) > 30 mL in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>64762-0862-30</NDC11Code>
<ProductNDC>64762-862</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nbb</ProprietaryName>
<NonProprietaryName>Zinc Oxide, Zinc Gluconate, And Sambucus Nigra Flowering Top</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100601</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Dynamic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ZINC OXIDE; ZINC GLUCONATE; SAMBUCUS NIGRA FLOWERING TOP</SubstanceName>
<StrengthNumber>.25; 12.42; .05</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Reduces duration of the common cold. Reduces severity of cold symptoms: SneezingSore ThroatStuffy NoseCoughingCongestion.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>64762-864-15</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (64762-864-15) > 15 mL in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>64762-0864-15</NDC11Code>
<ProductNDC>64762-864</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Oxymetazoline Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxymetazoline Hydrochloride</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20091104</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Dynamic Pharmaceuticals</LabelerName>
<SubstanceName>OXYMETAZOLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>mg/.4mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Temporarily relieves nasal congestion due to: 1 common cold, 2 hay fever, 3 upper respiratory allergies, 4 helps clear nasal passages, 5 shrinks swollen membranes, 6 temporarily relieves sinus congestion and pressure.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>64762-870-25</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (64762-870-25) > 25 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE</PackageDescription>
<NDC11Code>64762-0870-25</NDC11Code>
<ProductNDC>64762-870</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nbb Citrus</ProprietaryName>
<NonProprietaryName>Zinc Gluconate, Zinc Oxide, And Sambucus Nigra Flower</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20091104</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Dynamic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ZINC GLUCONATE; ZINC OXIDE; SAMBUCUS NIGRA FLOWER</SubstanceName>
<StrengthNumber>1; 1; 1</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Reduces duration of common cold. Reduces severity of cold symptoms: stuffy nose, sneezing, sore throat, coughing, and congestion.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>64762-870-30</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (64762-870-30) > 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE</PackageDescription>
<NDC11Code>64762-0870-30</NDC11Code>
<ProductNDC>64762-870</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nbb Citrus</ProprietaryName>
<NonProprietaryName>Zinc Gluconate, Zinc Oxide, And Sambucus Nigra Flower</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091104</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Dynamic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ZINC GLUCONATE; ZINC OXIDE; SAMBUCUS NIGRA FLOWER</SubstanceName>
<StrengthNumber>1; 1; 1</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Reduces duration of common cold. Reduces severity of cold symptoms: stuffy nose, sneezing, sore throat, coughing, and congestion.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>64762-871-30</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (64762-871-30) > 30 mL in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>64762-0871-30</NDC11Code>
<ProductNDC>64762-871</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nbe</ProprietaryName>
<NonProprietaryName>Zinc Gluconate And Zinc Acetate</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100930</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>Dynamic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ZINC GLUCONATE; ZINC ACETATE</SubstanceName>
<StrengthNumber>12.26; .46</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Reduces duration of the common cold. Reduces severity of cold symptoms:SneezingSore ThroatStuffy NoseCoughingCongestion.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>64762-873-25</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (64762-873-25) > 25 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE</PackageDescription>
<NDC11Code>64762-0873-25</NDC11Code>
<ProductNDC>64762-873</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nbe Citrus</ProprietaryName>
<ProprietaryNameSuffix>Cold Remedy Fast Melting (rite Aid)</ProprietaryNameSuffix>
<NonProprietaryName>Zinc Acetate And Zinc Gluconate</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101004</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Dynamic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ZINC ACETATE; ZINC GLUCONATE</SubstanceName>
<StrengthNumber>2; 1</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Reduces duration of the common cold. Reduces severity of cold symptoms: Sore Throat, Stuffy Nose, Sneezing, Coughing, and Congestion.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>64762-874-25</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (64762-874-25) > 25 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE</PackageDescription>
<NDC11Code>64762-0874-25</NDC11Code>
<ProductNDC>64762-874</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nbe Cherry</ProprietaryName>
<ProprietaryNameSuffix>Cold Remedy Fast Melting (rite Aid)</ProprietaryNameSuffix>
<NonProprietaryName>Zinc Acetate And Zinc Gluconate</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101004</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Dynamic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ZINC ACETATE; ZINC GLUCONATE</SubstanceName>
<StrengthNumber>2; 1</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Reduces duration of the common cold. Reduces severity of cold symptoms: Sore Throat, Stuffy Nose, Sneezing, Coughing, and Congestion.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>64762-884-25</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (64762-884-25) > 25 LOZENGE in 1 BOTTLE</PackageDescription>
<NDC11Code>64762-0884-25</NDC11Code>
<ProductNDC>64762-884</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nbe Cool Mint</ProprietaryName>
<ProprietaryNameSuffix>Cold Remedy Fast Melting</ProprietaryNameSuffix>
<NonProprietaryName>Zinc Gluconate</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110801</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Dynamic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ZINC GLUCONATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Reduces duration of common cold. Reduces severity of cold symptoms: stuffy nose, sneezing, sore throat, coughing, and congestion.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0409-4162-03</NDCCode>
<PackageDescription>12 POUCH in 1 CASE (0409-4162-03) > 1 BAG in 1 POUCH > 500 mL in 1 BAG</PackageDescription>
<NDC11Code>00409-4162-03</NDC11Code>
<ProductNDC>0409-4162</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aminosyn Ii</ProprietaryName>
<NonProprietaryName>Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic Acid, Glutamic Acid, Histidine, Proline, Serine, N-acetyl-tyrosine, And Glycine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20050729</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019438</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; HISTIDINE; PROLINE; SERINE; N-ACETYLTYROSINE; GLYCINE</SubstanceName>
<StrengthNumber>561; 850; 893; 146; 253; 340; 170; 425; 844; 865; 595; 627; 255; 614; 450; 230; 425</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC],Amino Acids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-04-18</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0409-4162-05</NDCCode>
<PackageDescription>6 POUCH in 1 CASE (0409-4162-05) > 1 BAG in 1 POUCH > 1000 mL in 1 BAG</PackageDescription>
<NDC11Code>00409-4162-05</NDC11Code>
<ProductNDC>0409-4162</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aminosyn Ii</ProprietaryName>
<NonProprietaryName>Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic Acid, Glutamic Acid, Histidine, Proline, Serine, N-acetyl-tyrosine, And Glycine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19860403</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019438</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; HISTIDINE; PROLINE; SERINE; N-ACETYL-TYROSINE; GLYCINE</SubstanceName>
<StrengthNumber>561; 850; 893; 146; 253; 340; 170; 425; 844; 865; 595; 627; 255; 614; 450; 230; 425</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC],Amino Acids [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-05-23</LastUpdate>
</NDC>
</NDCList>